Read answers to the frequently asked questions (FAQ) we receive about conducting early-stage, early-feasibility (EFS), and first-in-human (FIH) clinical studies in Colombia

General Questions

Why is Colombia a top destination for first-in-human (FIH) clinical trials?

Colombia checks positively on cost, speed, and quality; the main requirements for a medical device company to select a destination for its early-stage/feasibility human studies:

1. Cost: Savings are +30 percent over what the same trial would cost in North America or Western Europe.

2. Speed: The total IRB/EC and MoH (INVIMA) review in Colombia takes 90-120 days.

3. Quality:

   • The World Health Organization ranked Colombia's healthcare system as #22 in a review of 191 countries (read more).

   • The “America Economía" magazine ranked Colombia's hospitals as some of the best in Latin America (read more).

   • The International Living publication ranked Colombia's healthcare system within the top five in the world (read more).

   • Hospitals in Colombia are only allowed to conduct clinical research with pharmaceutical drugs after they have passed a rigorous ICH/GCP certification process.

4. Patient recruitment: Colombia's population is +50 million. About 95 percent of the Colombian population is covered by universal healthcare.

5. R&D tax and financial incentives: Investments in science, technology, and innovation projects get a 100% tax deduction, a 25% tax discount, a 50% future tax credit, and about $10 million in free government money grants. Read more.

Read more.

In a nutshell, what's the process to get a clinical trial approved in Colombia?

1. Obtain study approval from your site's institutional review board (IRB)/ethics committee (EC).

2. Obtain study approval from Colombia's regulatory agency (INVIMA)/Ministry of Health (MoH).

3. Obtain an import permit at Colombia's Ministry of Industry and Commerce (MinCIT) and ship your investigational devices to your site in Colombia.

Read more.

Has the media wrote about clinical trials in Latin America and more specifically in Colombia?

Yes. Clinical Leader has articles here about clinical research in Latin America and in Colombia.

Who is bioaccess™? What's its story?

It all started when Dr. Pedro Martinez-Clark —a Harvard-trained interventional cardiologist was a professor at the University of Miami (UM) and in the late 2000s, with Dr. William O'Neill, Dr. Eduardo DeMarchena, and other US physician researchers at UM, started collaborating with a research center in Colombia to do the clinical validation of a new cardiac valve in Colombia read more) being developed by a US Medtech startup. This led Dr. Martinez-Clark to realize that US medical device companies needed help finding cost-effective, ethical and fast investigator and clinical research centers in Latin America, and operationalizing their first-in-human clinical trials in the region.

This led Dr. Martinez-Clark to start a company called Interventional Concepts, Inc. —a Miami-based contract research organization (CRO) dedicated to helping US medical device startups conduct first-in-human clinical trials in Colombia (read more). Later in 2016, the company changed its name to bioaccess™ to reflect its wider focus on clinical research, regulatory, and market access services.

bioaccess™ is now a CRO, regulatory, and market access consulting company that delivers a full spectrum of clinical, regulatory, and market access offerings from bench to commercialization so that medtechs can succeed in Colombia. Our promise is for medtechs that believe that Colombia offers untapped potential to conduct clinical trials or to sell their innovations. We focus on medtechs that want to run a clinical trial or want to have sales growth in Colombia. We promise that by engaging with us, you will cost-effectively get the clinical data you need or will be able to obtain regulatory market clearance in Colombia. 

What's your relationship with the U.S. Commercial Service?

bioaccess™ is the only CRO, regulatory, and market access consulting company vetted and approved as a business service provider to help US medical device companies do business and succeed in Colombia. Read more.

Do you have a slide deck about your company and capabilities?

Yes, we do. See it here.

What's the scope of your CRO clinical trial services in Colombia?

We can help you operationalize your planned first-in-human medical device clinical trial in Colombia by providing you with the following services:

• Study design (i.e., protocol writing, production of the study documents including study protocol, investigator's brochure, subject informed consent, case report form) –in partnership with Beacon Launch Partners.

• Feasibility (i.e., investigator/site selection).

• Coordination and attendance of sponsor pre-trial visit in Colombia.

• Coordination and execution of the clinical trial agreement (CTA).

• Gathering, reviewing study documents, and translations to Spanish: Protocol, investigator's brochure, insurance policy, principal investigator (PI) training certification, and additional supporting documentation as required for approval. 

• Study submission to the site's ethics committee (EC): Includes gathering of local EC requirement checklist, editing, and assembly of submission package (excludes applicable submission fee). 

• Study submission to the MoH (INVIMA): Includes completing the application, editing of study documents to comply with INVIMA's guidelines, and final assembly (excludes applicable submission fee).

• Submission of the import permit application to Colombia's Ministry of Industry, Commerce, and Tourism (MinCIT).

• Processing of the importation/nationalization of the investigational product.

• Coordination and attendance of site initiation visit and training to site's PI, study coordinator, and relevant staff. 

• Project management.

• Study monitoring.

• Reporting (as mandated by INVIMA and the IRB/EC).

What is INVIMA in Colombia?

INVIMA (Colombia National Food and Drug Surveillance Institute) or “Instituto Nacional de Vigilancia de Medicamentos y Alimentos” in Spanish is a regulatory authority created in 1992 under Colombia's Ministry of Health and Social Protection (MoH or MinSalud). INVIMA is in charge of inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards or procedures, and implementing best practices and providing medical approval for the import and export of products.

The entity within INVIMA that deals with medical device matters is the Directorate for Medical Devices and other Technologies or “Dirección de Dispositivos Médicos y Otras Tecnologías” in Spanish; subordinated directly to the General Directorate. The directorate monitors and controls medical devices, tracks pre- and post-market programs and, among others, suggests technical standards for the manufacturing, marketing, surveillance, and quality assurance of devices.

The Pan American Health Organization/World Health Organization has categorized INVIMA as a Level 4 regional reference health authority. A Level 4 national regulatory authority is one that is competent and efficient in performance of the health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines. Read more.

What's the quality of healthcare in Colombia?

When the World Health Organization ranked the healthcare systems of 191 countries, Colombia came in at #22. That is better than Canada at #30 and the United States at #37. On top of this, when financial publication América Economía put together their latest annual list of Latin America’s top 58 hospitals, 23 of those hospitals were based in Colombia. That means that 40% of the top Latin American hospitals are located in Colombia.

Four of these hospitals are Joint Commission International accredited, the gold standard in world health. Two are located in Bogotá (Fundación Cardioinfantil – Instituto de Cardiología, and Hospital Universitario Fundacion Santa Fe de Bogotá), one is located in Medellín (Hospital Pablo Tobón Uribe), and one is located just outside of Bucaramanga (Fundación Cardiovascular de Colombia – Instituto del Corazón).

Source: International Living, PROCOLOMBIA.

Does the Ministry of Health in Colombia have a nationwide database to capture all the patient encounters, procedures, prescriptions, etc. to find the hospitals with the most volume of patients and make it easier for a drug or medical device clinical trial sponsor to recruit subjects?

Yes! Colombia is the country in Latin America that does the best job in capturing all the patient encounters, procedures, prescriptions, etc. Colombia’s Ministry of Health (Minsalud) has three powerful databases (i.e., SISPRO, MIPRES, SISMED) that we can tap into to find answers to healthcare questions.

There’s only one company in Bogota that has licensed this data from Minsalud and has a copyrighted algorithm to do data mining, business analytics, and user-friendly and graphical visualization of the raw data in the databases. The data in these databases cover close to 95% of the Colombian population that is covered by the country’s universal healthcare system. This company in Bogota can help us determine —among other things— the number of patients for a determined condition/disease, what drugs they take, what medical procedures they underwent, and in what specific hospital(s) patients are been treated for the diagnosis of interest. This significantly speeds up and facilitates site selection and patient recruitment in a clinical trial. 

We are looking for an investigator and a site to conduct our first-in-human trial, but we are not sure if Colombia is the right place. Can you help us?

Some medical device companies in need of first-in-human (FIH) clinical trials help approach bioaccess™ after they have identified a principal investigator (PI) in Colombia at an international conference or through their personal and business connections. This PI is usually someone who has demonstrated expertise in the intended use of the investigational device after presenting at international conferences or after publishing in recognized academic journals. 

Only after the medical device company has been in direct contact with the PI and has decided to have him lead and conduct its (FIH/FIM) trial is when we at bioaccess™ come in and operationalize the trial in Colombia. We contact the PI, gather IRB/EC requirements at the PI's hospital, assemble the dossier package for IRB/EC submission, and then apply for MoH (INVIMA) approval. We also help with the importation of the investigational devices and become the project managers and monitors of the study. 

So, the choice of conducting a trial in Colombia is first driven by the medical device company's choice of a PI in Colombia. Asides from having the right PI leading your study in Colombia, the country’s advantages are in essence: a) fast MoH review, b) cost savings (~30% savings over US hospital fees), and c) large patient pool (+50 million people with universal health care). 

If your company hasn’t found an investigator in Colombia who has expressed his interest in participating in your FIH trial, then we will have to find it for you —we offer site and PI selection services. 

We are looking to do a pivotal medical device clinical trial in the US and would like to include foreign clinical data to lower our costs. The incentive to do this would be if we would see a significant reduction in cost as compared to conducting the trial in the US. Of course, this would only work if the FDA will accept the outside-the-US (OUS) data. Can you steer us in the right direction?

There will be a significant cost reduction in a country like Colombia. You can expect savings of about 30% vs US hospital prices. The FDA accepts oversees clinical data as long as it is acquired following ICH/GCP guidelines. All the research sites in Colombia follow ICH/GCP and +120 of them are ICH/GCP certified by Colombia's Ministry of Health. Read more here.

I am not sure how data collection and monitoring may differ in Colombia. The online electronic data capture (EDC) solution we would use may not have a Spanish version. We need something that can export a statistical analysis software (SAS) database for the statistician to work with.

• It’s fairly common for study coordinators in Colombia to enter information in English-based EDCs. There’s no need to have the EDC interface in Spanish. 

• You could send your monitor from the US (preferably bilingual) to the site in Colombia or you can hire our CRO monitoring services to send one of our local monitors to the site (you will save on travel expenses). 

We are planning a trial in Colombia. We already have the site and principal investigator selected. How can you assist us?

If you have a site and principal investigator already selected in Colombia, we can assist you by providing you with our contract research organization (CRO) services in Colombia. We can help you with the trial set-up (e.g., budget and clinical trial agreement approved and executed, ethics committee and Ministry of Health/INVIMA submission, import license, logistics/storage/shipment to site, etc.). We can also help you with post-approval services (e.g., project/study management, site monitoring, medical writing, etc). Read more about our trial-set up services here. 

Will our company staff be able to scrub-in with the local investigator at a site in Colombia?

Yes. All of our clients/sponsors want to be able to bring their engineers, physicians, and other relevant staff for cases at sites in Colombia. We understand the needs of early-stage medical device companies, and we can accommodate any special request they have to work at a lab in a site in Colombia. We only work with investigators in Colombia at sites that are open to allowing the staff from our clients/sponsors to temporarily “own” the lab or operating room where cases will be done.

As part of a clinical trial in Colombia, is it possible for a foreign physician to perform the investigational procedure on subjects with the intention to train the Colombian physician/investigator and/or perform the first few procedures?

Yes. Regulations in Colombia have something called Permisos transitorios a personal de salud extranjero (translated as Temporary permits for foreign healthcare professionals). It’s basically a permit that is submitted to the Colegio Médico Colombiano (the Colombian version of the American Medical Association). This permit is valid for six (6) months and can be renewed with the right justifications. To obtain this permit, the applicant (the hospital/research center in Colombia) must submit an application that includes the foreign physician's CV, his/her medical license in the US, a letter describing the participation of the foreign physician in the project, proof of INVIMA approval, etc. Applicants must submit the application at least 20 days before the project starts. After the approval of the Temporary permits for foreign healthcare professionals, the research center must obtain a local malpractice insurance policy with a coverage of at least USD $60,000 that protects patients from the acts of the foreign physician.

Principal investigators in Colombia at smaller hospitals usually let foreign specialists get in the operating room (OR) to do cases for training purposes with any red tape or formal approvals before they obtain the Temporary permits for foreign healthcare professionals. They know that foreign physicians are qualified to deliver training and this permit is just a required formality to comply with local regulations.

Can we have a trained US physician/surgeon who has much expertise on the investigational medical device we are developing and its procedure? … or must the surgeon be from Colombia?

Yes, you can bring foreign physicians to participate in a clinical trial in Colombia and perform procedures alongside the Colombian principal investigator in your study.

We don't speak Spanish and would like to make sure we have good communication with our chosen principal investigator (PI) and the staff at his/her hospital in Colombia. How can you at bioaccess™ facilitate this communication?

We have bilingual team members in Colombia, and any of them will be with you during your site visits to Colombia and during the procedures. Our director of research (Cris Venner) is based in Barranquilla, Colombia. Osvaldo Martinez-Clark (our VP of Business Development) is based in Barranquilla, Colombia. Julio Martinez-Clark (our CEO) spends about 50% of his time in Colombia. Any of them will be available to travel with you to the chosen site/hospital for site visits and/or the procedures and will be facilitating any interaction with the PI and the hospital staff. 

How many institutional review boards (IRB) are there in Colombia? 

Colombia has about 70 IRBs (also known as “research ethics committees” or ECs) that INVIMA has certified in Good Clinical Practice following ICH/GCP international guidelines. Every site in Colombia can only be associated with one IRB/EC at any point in time.

Source: INVIMA

How many hospitals in Colombia are ICH/GCP-certified as clinical research centers/sites? 

There are 120+ health institutions (aka IPS' in Colombia) that Colombia's regulatory agency (INVIMA) has certified in Good Clinical Practice following ICH/GCP international guidelines. 

Source: INVIMA

I've got another project I want to do in Columbia.  One of the decision-makers is skeptical, though, that we can achieve the level of control - implant procedure, and overall data quality - we need.  We have a strategy presentation to investors on Wed afternoon.  Do you have time this week - Mon, Tues or Wed morning to talk about clinical trials in Columbia, and what you can do for us to ensure quality?  

Your worries are common to all of our clients/sponsors: 

1. Level of control/implant procedure: A physician or a clinical member of your team will be able to scrub in with the Colombian investigator and participate in all of the procedures. If he/she is a licensed physician in the US, we’ll get him/her a temporary license to perform surgery in Colombia. All we need from him/her is a copy of his/her medical license and passport. 

2. Overall data quality: 

• Clinical research centers in Colombia are ICH/GCP certified on top of each individual participating in research (i.e., the PI, study coordinator, etc.) being ICH/GCP certified individually (read more here). This means that the Ministry of Health ensures that they have quality processes to conduct clinical research (i.e., SOPs, a dedicated pharmacy for research, a dedicated filing system for research, consult research rooms, and a space to take blood/urine samples for research). Colombia is the only country in Latin America with this requirement. This provides quality data to sponsors. These ICH/GCP centers already conduct research for the top pharmaceutical companies (i.e., Pfizer, AbbVie, Novartis, J&J, Roche, BMS, Merck, Sanofi, etc.) and the top CROs (i.e., PPD, ICON, IQVIA, Paraxel, Medpace, Syneos, Labcorp, etc.). 

• We always dedicate a physician study manager to oversee each one of our studies in each research center. This, on top of the study monitor, ensures that the study is carried out according to the protocol and that the data is captured appropriately. The study manager is always physically present with the sponsor in each implant procedure. 

Questions about Clinical Research Sites/Centers in Colombia

What are the sites you (bioaccess™) work with and their capabilities?

Colombia had +5,000 healthcare service providers. This includes ambulatory care (66%), hospitals (17%), promotion and prevention centers (11%), and ancillary service providers (6%). Out of the +5,000 service providers, about 1,000 are general hospitals that could be activated for medical device clinical trials.

Since 2010, bioaccess™ has worked with sites in Barranquilla, Bogota, Bucaramanga, Buga, Cali, Medellin, and Zipaquirá in a myriad of medical device clinical trials involving several therapeutic areas that include cardiology, ophthalmology, gene therapy, nephrology, orthopedics, angelology/vascular, neurology, endocrinology, etc.

Will the FDA accept data from an OUS clinical research site in Colombia? We want to initiate an early feasibility (ESF) study in Colombia; if such a study were conducted in Colombia, would it meet all the requirements that the FDA requires so we can begin a pivotal study next in the US?

Yes! For international inspections of clinical trials/clinical investigations, the FDA requires conducting the trials according to GCP and under the Ethics Committee approval. For medical devices, the FDA requires the conduct of the trial according to the Declaration of Helsinki (a requirement by Colombian law in Resolution 2378) and to the laws and regulations of the country where the trial is taking place.

If a Colombian research site conducts its study following ICH/GCP and/or receives a Good Clinical Practice Certificate from INVIMA, then it is also compliant with FDA requirements for international inspections for studies involving investigational drugs and biologics as well as for studies involving investigational medical devices.

Read more. 

Questions About Subject Recruitment

What are the approved subject recruitment activities in Colombia? Do you know what is allowed and what is not?

Colombian clinical research laws do not specifically state what activities a clinical research site can and can't do to recruit subjects for a clinical trial. The simple answer to your question is that the ethics committee (EC) at the site where you are planning to conduct your clinical trial and INVIMA must approve any promotional material that you plan to use to recruit patients.

Can a sponsor/company bring foreign subjects for the clinical trial in Colombia? … or must all the subjects be Colombian citizens or residents?

Yes, foreign non-Colombian citizens or residents can participate in a clinical trial in Colombia. Colombian clinical research regulations don't condition patient recruitment to the citizenship of the subject admitted in a clinical trial.

Can bioaccess work with us (as sponsors) on a subject recruitment campaign in Colombia?

Yes! We can design ads, a landing page, a questionnaire in Typeform, and activate a social media campaign on Facebook and Instagram. Read more here.

Regulatory Timeline

What are the time variables that a medical device company must evaluate to start a first-in-human medical device clinical trial in Colombia?

The time it takes to approve a clinical research study in Colombia has four (4) main variables.

1. Search for principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia).

2. Approval time of the ethics committee associated with the hospital/site/research center.

3. Approval time at the regulatory agency (INVIMA)/MoH.

4. Approval time of the import permit of the devices under investigation (VUCE).

In a blog post, we explain the reason why the selection of the principal investigator is really what could make a study successful or not. Read more.

What is the IRB/EC review timeline in Colombia?

Every IRB/EC has its own meeting schedule, however, generally, an IRB/EC in Colombia meets about every 15 or 30 days.

Every hospital in Colombia has its own IRB/EC and their review times depend on their scheduled meeting frequency, and on how efficient and busy they are. Some IRB/ECs meet every week, other ones every two weeks, and other ones meet every 30 days. Top and well known hospitals in Bogota or Medellin usually have longer EC review times. In secondary cities like Cali or Barranquilla, the EC review time at regular hospitals is faster. 

You should contact the site that you have in mind for your trial in Colombia, and its staff will tell you the meeting dates for their respective IRB/EC. INVIMA publishes a list of clinical research sites in Colombia and their corresponding IRBs; see the list under the title “Centros de Investigación/Comités de Ética Vinculados a Instituciones Certificadas en Buenas Prácticas Clínicas.”

What's the typical competent authority (INVIMA) cycle time for the review of a medical device clinical trial in Colombia?

INVIMA's medical device committee meets every 30 days (see their meeting schedule here). So, this means that the review takes about 30 days (providing your dossier package/application is reviewed at that meeting). The meeting minutes are published about 7-15 business days after the meeting date. Only when the meeting minutes are public, you will know if INVIMA's medical device committee approved your application or it is requesting additional documentation or clarification before another review (and hopefully approval) at their next meeting.

What has been your typical experience? Does INVIMA's medical device committee typically take the full 40-45 days?  

Yes.

Does this INVIMA timeframe include an opportunity to address and respond to questions or would their questions be issued only at the end of 40-45 days?

Their questions will be issued at the end of the 40-45 days. You will have to submit your answers before the deadline of INVIMA's next meeting.

Does INVIMA have a required time frame to getting back to the sponsor after responses to their questions have been submitted?

No. INVIMA will review your answers and will decide at their next meeting whether to approve your study or not.

For site selection, can you please outline the process of helping us find a clinical study site that would meet our criteria? We have a list of some potential investigators and sites from PubMed searches for applicable devices. What would be other ways in which bioaccess™ could recommend potential sites?

Most trials fail for lack of patient recruitment. Starting with an investigator doesn't guarantee patient recruitment. We first identify a hospital with a large volume of patients for the indication of use of the investigational device. After this step, we contact and explain the study to their research center, and if they express interest and show us subject recruitment potential, then they will name an investigator for the study. We rely on a) a database of the Colombian Ministry of Health to find the hospitals with the most volume of patients for a specific diagnosis, b) the relationships we have created with the top hospitals in the country. 

Could you estimate time frames for study initiation (best case, expected case, and risks/assumptions)? I understand in Colombia INVIMA approval is needed and then EC? Do we need a clinical trial agreement (CTA and budget to start the process?

• Timeline: The expected best case is that we get the study initiated in 90 days. The expected worse case is that we get the study initiated in 120 days.

• Assumptions: Your study documents are ready for us to review, translate, and submit to the EC and INVIMA. See a detailed list of INVIMA study evaluation requirements here.

• Approval Pathway: EC approval first, and then INVIMA.

• Clinical Trial Agreement (CTA)/Budget: Most ECs don't ask for it to start the EC evaluation process. A few large hospital EC's do.

Questions About Clinical Trial Costs/Budget

We are a startup with investors lined up. We are finishing up our prototyping stage and summing up the capital we are raising to the investor. We are mainly looking for some initial big picture cost for the clinical trial and regulatory process compared to other countries that we have in mind like Australia in which we do have a specific site we have in mind. We are new to the clinical trial space in Latin America and would like your opinion on the potential benefit and cost of our current plan.

• Whatever cost you were quoted in Australia, then it’s safe to assume that you will save in Colombia anywhere between 30% off of that per-patient price.

  • Only after we formally engage, we will be able to extract every single activity from the schedule of events in your study protocol, build a budget grid, populate it with the prevailing market price for each trial activity in Colombia, and then propose the budget to a site for negotiation and approval. Please see the “Cost” section of our FAQ for details about how to budget a clinical trial in Colombia.

  • Please see a sample study budget here. We proposed, negotiated, and approved this budget at a site in Colombia based on the prevailing market prices for each activity.

• On top of the cost savings in Colombia, you will also have a faster approval and a better chance of reaching your recruitment goals in a country like Colombia. The approval timeline in Colombia is sequential and consist of the following:

  • Local IRB/EC approval (depending on what site we choose).

  • Ministry of Health (INVIMA) review cycle (after IRB/EC approval).

  • Import permit approval.

• Document requirements, approval process, etc: See here.

• This article that we wrote for Med Device Online may be insightful as you become more acquainted with Latin America’s medical device clinical trial capabilities: Should You Conduct Your Medical Device Clinical Trial In Latin America?

How much does a medical device clinical trial in Colombia cost (USD)? 

The cost to conduct a medical device clinical trial in Colombia is about 30% less than what it would cost to conduct the same trial in the US, Canada or Western Europe. These are the typical cost components on a medical device clinical trial project: 

1. Study design fees: This includes the medical writing cost associated with designing your study and producing its respective documents (i.e., protocol, investigator's brochure, patient informed consent form, case report form). If you decide to outsource this activity to a contract research organization (CRO), then the cost varies depending on the complexity of the study, and it may range anywhere from $35,000 to $60,000 (or more) depending on the number of hours involved.

2. Hospital fees:

   • These fees will depend on the schedule of events in your study protocol. Every trial is different; it is difficult for us as a CRO to give you a ballpark price per patient without fully reviewing your study protocol and creating a detailed proposed budget based on market prices in Colombia.

   • Prices in Colombia are typically about 30% lower than what the same study would cost at a hospital in North America or in Western Europe.

   • Based on our vast experience running clinical trials in Colombia, these are our comments about hospital fees in Colombia:

     • Fees can be grouped at about $2,000-$3,000 for simple minimally-invasive procedures with short follow-ups; $3,000-$5,000 for moderately invasive procedures with some follow-up visits; and $5,000-$15,000 for highly-invasive procedures with several follow-up visits. These fees may vary ±25% depending on the schedule of events in your study protocol and current market pricing for healthcare services in Colombia at the time of the execution of our master services agreement (MSA). These are some typical charges that a site in Colombia may include in a study budget:

       • Ethics Committee Submission: $800

       • Screen Failures: $500

       • Adverse Event Reporting: $200

       • Start-up fee: $2,000

       • Close-out activities: $700 

       • Device inventory management set-up fee: $350

       • Long-term archiving fee: $400 

       • Monthly administrative fee: $150

       • Site Overhead: 20%-25%

     • A hospital/research site in Colombia will typically not prepared and send you a detailed study budget after reviewing your study protocol. A hospital/research site in Colombia expects that you (sponsor) or we (CRO) propose a detailed study budget to them so that they can either accept or negotiate the individual pricing for each activity in the schedule of events inside your study protocol.

     • After you formally engage our CRO clinical research services in Colombia by executing our MSA, we'll look at the schedule of events in your study protocol and create a detailed budget based on market pricing in Colombia. We'll then propose this budget to a site and will negotiate with it the final study budget.

   • If you don’t have a proposed study budget we will have to contact several sites to ask them for a per-patient ballpark cost, and they are usually slow in responding to this type of request (it is a lot faster if we send them a proposed budget). Once you formally engage us as your CRO for your clinical trial in Colombia, our first order of business is to extract the schedule of events from your study protocol, create a customized budget grid, research the average prices in Colombia for each of the study activities, and present it to your chosen site for negotiation and approval before we facilitate the execution of a clinical trial agreement (CTA) between your company and the site in Colombia. See a sample hospital study budget here.

3. Submission fees: About $3,000 (this includes IRB/EC submission of about $1,500 and INVIMA fees of about $1,500).

4. Translations (from English to Spanish): Expect to translate about 1,300 pages of documents and pay about $3 per page to a translator in Colombia. We facilitate these translations for you and invoice them at cost as a pass-thru expense.

5. CRO fees: You should budget about $75,000 to $150,000 depending on the services you choose to contract your CRO for. This amount could be higher for a study with a lengthy follow-up period (1-5 years). This includes the following essential activities:

   • Search & Selection of Site and Principal Investigator.

   • Trial Set-Up.

   • Trial Start-Up.

   • Device Importation.

   • Registered Agent/Legal Representation/Importer of Record.

   • Other activities such as study project management, subject recruitment campaign in social media, reporting, management of payments to the site, and study monitoring are optional and will be priced separately. 

6. Miscellaneous: Travel expenses, clinical trial insurance policy, custom agency/broker import duties/fees.

Will I receive a hospital budget before I decide to contract your CRO clinical research services?

No. A research site in Colombia will expect that you (sponsor) or we (CRO) propose a detailed study budget. After you formally engage our CRO clinical research services in Colombia, we'll create a detailed budget based on market pricing in Colombia. We'll then propose this budget to a site and will negotiate with it the final study budget.

Will your CRO budget be our total cost to execute our study in the hospital/site we've selected in Colombia, or as we presume, the hospital/site would assess additional charges per patient (ICU care required-which should be only 1-2 days per patient, and time in the cardiac catheterization lab to insert and remove the device, and fees for physician care)?

The “Budget" section of our proposal doesn’t include hospital fees. Once we formally engage, our team in Colombia will carefully review the schedule of activities table in your study protocol (Table 1, page 15), will gather the prevailing local market prices for each one of the activities/hospital services required in the study, and will produce a detailed budget proposal to the site. Please see here a budget we just completed for a clinical trial that we will conduct at San Vicente Fundación University Hospital. Hospital/site fees in Colombia are about 30% less of what you would pay for similar services in the US. We will only know the study per patient cost once our team in Bogota does it job and produces the study budget. 

Questions About Clinical Trial Insurance

How much would you guess clinical trial insurance might be for a small 5-10 patient study in Colombia.  

For one of our client/sponsors, on a 10-subject study, Clinical Trial Insurance Services (CTIS) recently quoted them a premium about $7,500 (plus local sales tax) for a $1,000,000 limit for 12 months. This was for a study that required the implantation of a vascular device to treat chronic venous insufficiency.

We don’t get involved in securing insurance for our clients/sponsors. They usually get their insurance policies directly with their own insurance agents. This page has some names of US insurance agencies our sponsors have used in the past.

Do you have a relationship with a local clinical trial insurance provider ? in some jurisdictions we need to provide clinical trial insurance with the application to the ministries of health and or hospital IRBs. We can normally arrange insurance coverage within a week but, for example, in Panama, it took us around 4 weeks to get insurance through a local provider.

All of our clinical trial clients/sponsors obtain insurance from their insurance agents in the US or Europe. Their agents will place their policies with a top global insurance company (e.g., Chubb, Travelers, Liberty, etc.). These brokers or global insurance companies will issue an insurance certificate that will list the names of the principal investigator, the clinical research sites, and their physical addresses. This insurance certificate is enough to comply with INVIMA's requirement. However, we suggest our clients/sponsors to work with their insurance brokers to obtain an insurance certificate issued by the local Colombian office of their insurer (almost all of the top global insurers have offices in Bogota). This page has some names of US insurance agencies our sponsors have used in the past.

Questions About Investigator-Initiated Trials (IITs) vs Industry-Sponsored Trials (ISTs) in Latin America

I am planning to conduct an investigator-initiated trial (IIT) in Canada. I was given a cost of $8,000 to $10,000 per patient. Will this cost be lower in Colombia?

Sponsoring a clinical trial entails numerous regulatory responsibilities, including those set forth in 21 CFR 312 and 812. There is no “lite” version of sponsor responsibilities for sponsor-investigators.

Regardless of who sponsors/funds a trial (for investigator-initiated trials (IIT): a for-profit, non-profit, state, or federal agency; or for industry-sponsored trials (IST): a for-profit entity), you will likely receive from a site a detailed budget. Usually, when a site or an investigator gives you an approximated cost-per patient it only includes actual clinical costs based on the schedule of events on the protocol, and indirect costs (i.e., administrative fees related to start-up costs, an overhead of about 20-25%, study coordinator time, record storage, and other activities). 

The costs that an industry-sponsor typically saves on an IIT vs an IST are the following,

• Study design (i.e., protocol creation and its accompanying documents including the case report form, the patient informed consent, and the investigator’s brochure).

• Study monitoring cost.

• Data collection and statistical analysis cost.

• Medical writing and publication of the results.

On an IIT, the study design/protocol is a) authored by the investigator within the course and scope of his/her university/hospital employment; or b) an investigator within the course and scope of his/her university employment jointly with an employee of another entity (e.g., an employee of another non-profit institution or an employee of the company funding the study). The same goes for the other costs that I mentioned above. 

One of the greatest challenges for IIT is the contract negotiations toward a clinical trial agreement, which averages 70.5 days among the companies surveyed for a recent report by Cutting Edge Information, a Research Triangle Park, N.C.-based business management and consulting firm. The primary reasons for such elongated timelines: complicated contract review processes and complex negotiations and/or disagreements.

If you decide to conduct an IST, then your company will likely assume the cost of designing the study and authoring the protocol and its accompanying documents. This cost may be around $20-60k depending on the complexity of the study. You —the sponsor— will also have to assume the other costs that I mentioned above. Once a life sciences company agrees to fund an IST, they are essentially investing money on a trial over which they have not much control. 

IIT clinical trial agreements (CTAs) are different from CTAs for ISTs for three main reasons:

• The company does not have the sponsor’s regulatory responsibilities.

• The investigator is asking for help from the company, instead of the other way around.

• The investigational product is usually a marketed product (as in Phase IV studies).

The main areas of interest in IIT CTAs are the following:

• Compliance with laws.

  • Clearly specific who is the “sponsor” from a regulatory perspective.

  • Sponsor (i.e., PI and/or site, if site is contracting on PI behalf) must comply with applicable laws and regulations.

  • From industry perspective, helps ensure company can use data in FDA applications, if needed/desired.

• Investigator and sponsor duties.

• Data ownership rights.

  • Site/investigator typically owns data, but provides company with
    periodic and final reports.

  • Site/iInvestigator may provide a data license to company.

• Intellectual Property (PI).

• Publication:

  • Typically more liberal publication rights for investigator, although company may still review (and perhaps comment) and postpone for certain reasons.

  • Memorialize that investigator is “responsible party” for clinicaltrials.gov purposes.

• Privacy (including HIPAA).

• Confidentiality:

  • May or may not be mutual – companies often consider their interests in the study, what information they actual provide, and desired use of data and results.

  • Ex: Does the company want the ability to use the data in marketing submissions or otherwise?

  • Ex: Is the company supplying proprietary data to help develop study, or was the idea for the study completely the investigator’s?

• Audit/Monitoring:

  • Investigator is the sponsor and is therefore responsible for monitoring from a regulatory standpoint.

  • Company may require audit/monitoring rights, depending upon level of company’s involvement.

• Payments.

• Serious adverse event (AE) reporting obligations:

  • Investigator is the sponsor and responsible for regulatory obligations.

  • Agreement typically requires site/investigator to submit AEs to company.

  • In post-market context, company may be required to submit AEs if they are involved in the study.

• Termination rights.

• Indemnification:

  • Typically far more limited than in a regular CTA, but depends on company involvement with the study.

  • Ex: harms directly caused by company product (manufacturing defects/product liability); company use of study data.

• Subject injury (it varies): No company reimbursement vs.
  injuries directly caused by a problem with company product (similar to indemnification) vs. broader, if company is more involved with the study.

Subject injury and indemnification —a major focus in most ISTs with experimental treatments— are typically smaller factors in IIT CTAs because the investigational product is usually a marketed product and the company does not want to accept liability for a study over which it has minimal control. Normally, the company warrants that the investigational product is manufactured per specifications, the investigator indemnifies the company for subject injury, and the company indemnifies the investigator-sponsor for possible commercialization.

If you decide to conduct a trial outside your home country you will have to plan for costs associated with shipping an importation, international travel, and other miscellaneous items. We wrote an article that may give you some idea of the type of savings that you can have by running your trial outside of the US or Canada. The article is titled Did you know 40-65% of all clinical trials involving FDA-regulated products are being conducted overseas?

Every trial is different. It is almost impossible for anybody to give you an approximated cost per patient in Colombia without reading the protocol, identifying the schedule of events on it, putting together a budget grid, and contacting sites in Colombia for pricing. 

We have been involved with medical device clinical trials in Colombia that range from $1,500 to about $10,000 per patient in different therapeutic areas. Every trial is totally different from the other. All we can give you (based on our own experience and from gathering international data) is approximated percentages of the savings that you will have when conducting a comparable trial in the US vs in Colombia. 

What’s customary in IST is that the sponsor firsts presents a draft/proposed budget to a site (the sponsor sometimes hires the services of the CRO to create this budget), and then waits for the site to respond with a counteroffer. When you present a site a proposed budget, the site will look at it and will determine if it is willing to conduct the trial at your proposed prices or not; here is when the ping-pong game of budget negotiations begin until both parties agree on a final agreed-upon study budget that will be the genesis of a clinical trial agreement between the sponsor and the site. 

We want to keep clinical research fees very low. We assume that investigators in Latin America would want to self-fund our clinical trials so that they can publish the results and gain academic recognition. Are investigator-initiated trials (IIT) common in Latin America?

Latin America is a vast region of over 30 countries and 600+ million people. Many startup companies add Latin America to the territories where they aim to sell their products. A Latin America presence is usually a great way to add value to the company in front of investors and potential strategic acquirers. 

The ideal and faster way for life science companies to enter the Latin American market is through industry-sponsored trials (ISTs). Then, gaining regulatory market clearance approvals in the major countries (Mexico, Colombia, Peru, Chile, Brazil). Engaging key opinion leaders (KOLs) as proctors and promoters of innovative medical technologies will foster adoption and trust in the regional medical community. 

Most healthcare institutions in Latin America are not active in IIT research. Most of the healthcare institutions in the region are for-profit service provider businesses that focus on adding additional services to generate more revenue and increase their profits in the financial interest of their shareholders. 

Government funding in Latin America to fund IIT is very scarce. Only large not-for-profit healthcare institutions in Latin America are somewhat involved in IIT. The bulk of clinical research volume in Latin America is IST since healthcare institutions and countries see this as a way to export their services and diversify their service offering. 

If IIT is your preferred way to enter Latin America, then the members of a company's scientific advisory board may have Latin American KOLs in their network. If these KOLs are part of a large leading not-for-profit healthcare institution in the region, they may have the funding for IITs.  

These are the general activities that need to happen before a healthcare institution/clinic/research site can recruit patients for a formal world-class clinical trial. Each one of these activities usually occurs in every clinical trial and have a cost associated. Either the sponsor or the research site will have to fund each of these activities: 

1. A regulatory and methodological review of study documents (i.e., study protocol, investigator's brochure, case report forms (CRFs), informed consent form (ICF), subject recruitment marketing material) according to international guidelines per Good Clinical Practices (ICH/GCP), formatting and adaptation to local laws and regulations.

2. Translation of documents to the local language (Spanish and/or Portuguese). 

3. Execution of mutual non-disclosure and confidentiality agreements with the principal investigator (PI) and the research site. 

4. Creation of the study budget based on the local market rates for each of the activities in the study protocol, proposing the budget to the research site, and negotiating the final budget. 

5. Drafting, negotiation, and execution of the clinical trial agreement (CTA) with the research site. 

6. Gathering institutional review board (IRB) or ethics committee (EC) document requirements, assembly of the dossier, submission, follow-up, and approval. This activity also includes the payment of the IRB/EC fee (USD 1k-2k) to evaluate the study. 

7. Gathering Ministry of Health (MoH) document requirements, assembly of the dossier, submission, follow-up, and approval. This activity also includes the payment of the MoH fee to evaluate the study (USD 1k-2k). 

8. Obtaining an import permit to nationalize the investigational medical product. This activity may also apply to software products depending on local import regulations.

9. Documenting and setting up the subject recruitment campaign strategy (e.g., social media ads, trial subjects coming into the clinic). 

10. Project/study coordination and management (i.e., explanation of the ICF to trial subjects, and family members, coordination of the ICF signature with the PI, the subject and witnesses, completion of the CRF -paper or electronic data capture form-, coordination of the subject follow-up visits -in person or virtual, quality control of the clinical data).

11. Study monitoring. 

12. Gathering of study data and submitting the mandated periodic status reports to the IRB/EC and the MoH. 

13. Closure of the study and submission of the closure report to the IRB/EC and the MoH. 

14. Production of the final study report. 

Questions About Document Requirements for the Approval of a Medical Device Study in Colombia

What are the document requirements for a drug clinical trial approval in Colombia?

• Pharmaceutical drugs: See here.

• All other innovative medical technologies (biotechnology, gene therapy, tissue regenerating) in Colombia are considered "advanced therapies." Colombia's Ministry of Health/INVIMA will evaluate advanced therapy study approval applications on a case-by-case basis.

Do a fully executed clinical trial agreement/contract and budget are required for INVIMA clinical trial approval submission?

Yes, but only the study budget (final). You do not have to submit your clinical trial agreement between your company and the site in Colombia. Please see the question and answer above for clinical trial approval requirements at INVIMA in Colombia. 

Are all testing reports from verification and validation activities required to be submitted to an ethics committee and INVIMA or just the investigator brochure with results?

Both. You will need to provide all testing reports along with your investigator brochure with the results.

Does INVIMA require biocompatibility tests and animal studies be performed following GLP standards?

For animal studies that are to be submitted to INVIMA to support the safety of a medical device, Good Laboratory Practices (GLP) is not mandatory. INVIMA doesn’t specifically mention GLP on its requirements to approve a medical device study.

We have a medical device at the R&D (no approval by any regulatory body) stage and we want to know what type of biocompatibility testing would be sufficient for a Colombian IRB to approve a clinical study. Specifically, we would like to know if a systemic toxicity (90 day sub-chronic in rats) or an animal study (dog) would sufficient to show safety prior to proceeding with a clinical study in Colombia.

Would you be able to provide a list of required testing that would need to completed to submit to the MoH/INVIMA (i.e. EMC, biocompatibility, clinical evaluations, sterilization, summative, preclinicals, etc.)?

INVIMA has general requirements for pre-clinical testing. The INVIMA requirement is pretty open. INVIMA only asks for “pre-clinical studies." INVIMA wants to see that the device’s direct patient risks be mitigated by doing device level tests. It's up to the sponsor to prove to INVIMA the device's safety by providing as much documentation as the sponsor deems necessary. The basic tests that INVIMA expects are,

• Biocompatibility, sterility, pyrogenicity, stability, performance, animal studies (GLP is not necessary), etc. (as applicable), 

• Electrical safety, electromagnetic compatibility, etc. (as applicable).

You can read INVIMA requirements to approve a medical device clinical study here. 

Do I need a Good Laboratory Practices (GLP) certificate to get my drug trial approved in Colombia? 

No. You will only need to provide your Good Manufacturing Practices (GMP) certificate. Please see the requirements for trial approval in Colombia here. 

Questions About Importation/Nationalization of Investigational Medical Devices in Colombia

What's the process to import investigational devices into Colombia?

The following is the process to import the investigational product and additional accessories named on the clinical supply list sent with your INVIMA submission:

1. Apply —for each shipment— for an import permit approval at the VUCE office (Ministry of Commerce, Industry, and Tourism [MinCIT]). The average processing time is 7-10 business days. 

2. Ship your devices to a designated free zone in Colombia.

3. Process the nationalization of the devices through a licensed customs broker.

Third-party costs (i.e., customs broker, duties & taxes) for each shipment of investigational devices that you intend to nationalize in Colombia is about $1,000.

What information is needed so that we can get an import permit at VUCE within Colombia's Ministry of Industry, Commerce, and Tourism (MinCIT) for our investigational devices?

For the INVIMA submission, you provided a detailed clinical supply list, including,

• Lot number.

• Reference numbers.

• Quantity.

• Serial numbers (if available).

The above information, along with a proforma invoice, is needed when we start the import process after INVIMA approval. For the import permit, the VUCE office at Colombia's Ministry of Commerce, Industry and Tourism (MinCIT) and the customs agency (Bureau of National Taxes and Customs —DIAN) will verify what is being imported (lot numbers, ref. numbers, quantities) versus what INVIMA has already approved; if there everything matches, VUCE/MinCIT will quickly issue the import permit in just a few business days.

We will be carrying the investigational devices into Colombia. Will that be OK with INVIMA and the hospital where we will conduct our study?

• Colombia’s regulatory agency (INVIMA) requires that sponsors’ legal representative/registered agent/importer of record in Colombia (in most cases a local CRO like bioaccess) obtains an import permit after study approval. We will process this import permit at Colombia’s Ministry of Industry, Commerce, and Tourism (MinCIT) for you once we have the INVIMA study approval letter and you send us the proforma invoice of the investigational devices you plan to nationalize into Colombia. This import permit approval takes a few business days after submission. 

• Once MinCIT approves your import permit, we will process the nationalization of your investigational devices at Colombia's custom's agency (DIAN).

• You may carry your investigational devices into the country as part of your personal luggage, but no reputable hospital in Colombia will accept to take custody of investigational devices and implant them in patients without proper nationalization/importation paperwork. 

• Our study approval application to INVIMA will include a clinical supply list. Per INVIMA requirements, this clinical supply list will include the description, lot number, part number, and the serial number of the exact number of devices that the sponsor will use during the study. INVIMA mandates that by the end of the study, the sponsor’s legal representative/registered agent/importer of record in Colombia (in most cases a local CRO like bioaccess) provides a “device accountability report.” This report must include the list of devices nationalized, used, stored and/or discarded or returned back to its country of origin. 

• The Pan American Health Organization/World Health Organization has categorized INVIMA as a Level 4 regional reference health authority. The other Level 4 agencies in the Americas are Argentina/ANMAT, Brazil/INVISA, Canada/HS, Chile/ISP, Cuba/CECMED, Mexico/COFEPRIS, and the US/FDA. A Level 4 national regulatory authority is one that is competent and efficient in performance of the health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines (read more). INVIMA has tight control over investigational drugs and devices in Colombia and works in unison with Colombia's custom agency (DIAN) to make certain no investigational product gets into the country and used at hospital facilities without its proper importation formalities. Conducting your study in a country with a Level 4 regulatory agency and at an ICH/GCP-certified research center guarantees clinical data of excellent quality.

Will our company be able to bring any equipment we need to do cases at a site in Colombia?

Yes, you will. We will take care of the proper importation process to get your equipment at the site when you need it for cases. Just tell us what specific equipment you need to bring to Colombia, and at the time of submission of your application for study approval, we will add a clinical supply list with the details of the supporting equipment you need for your study.

What are our options to ship and nationalize investigational medical devices into Colombia?

Modality No. 01: Ordinary Importation:  Colombia’s regulatory agency (INVIMA) requires that sponsors have a legal representative/registered agent/importer of record in Colombia to import INVIMA-approved investigational medical devices. The following is the process to import the investigational medical devices and additional accessories named on the clinical supply list sent and approved with your INVIMA submission: 

1. Apply for an import permit approval at the VUCE office (Ministry of Commerce, Industry, and Tourism [MinCIT]). The average processing time is 7-10 business days.

2. Ship your devices to a designated customs-free zone in Colombia. The average processing time is 3-10 business days.

3. Process the nationalization of the devices through a licensed customs broker. The average processing time is 7-10 business days.

The detailed information about the investigational medical devices listed on the Clinical Supply List (lot number, reference numbers, quantities, serial numbers - if available) and a proforma invoice are needed when the import process starts. The customs agency (Bureau of National Taxes and Customs —DIAN) will verify that what is being imported (lot numbers, ref. numbers, quantities) versus what the import permit approved is consistent; if everything matches, DIAN will nationalize and release the shipment via issuing a document called "Declaration of Importation".

Under this modality, the investigational product and its accessories must be shipped to Colombia approximately three weeks before the scheduled date for the implantation of the investigational medical devices. No reputable hospital in Colombia will accept to take custody of investigational devices and implant them in patients without proper nationalization/importation paperwork. The Declaration of Importation is the proof of the proper importation of medical devices. This importation modality is the recommended modality INVIMA, and the research centers expect for any importation of investigational products.

Modality No. 02: Postal Traffic and Urgent Shipments (chapter 12, article 254 of Decreto 1165 de 2019): 

INVIMA doesn't allow the importation of unregistered medical devices sent by courier (i.e., DHL, FedEx, UPS, etc.) into Colombia. This is to prevent Colombian residents from buying unregistered medical devices from foreign sellers (e.g., Amazon, eBay, Alibaba). INVIMA and the Colombia customs agency (DIAN) work closely and together to inspect and process courier shipments of regulated products at airports.

These are the restrictions for urgent shipments to Colombia: 

1. The declared value cannot exceed USD 2,000.

2. The weight cannot exceed 50 kilograms (110.23 pounds).

3. The goods must not be subject to legal or administrative restrictions.

4. The goods must not include weapons, drugs, or any other product subject to international shipping restrictions.

5. No more than six (6) units of the same product.

6. The shipping box size cannot exceed 1.5 meters (59.05 inches).

This modality places the medical devices at risk of being held by DIAN since medical devices are subject to legal or administrative restrictions (item 3.3 above). If DIAN holds the shipment, it will require proof of the INVIMA registration as commercial or investigational medical devices before releasing them. DIAN may request the recipient to switch importation modalities from urgent to ordinary, which will require a customs broker and will take the time specified in option No. 1 above

Option No. 03: Hand-Carrying the Investigational Product as part of Personal Luggage: 

The customs process that will take place at the airport is uncertain if a passenger carries the investigational medical devices in their personal luggage. The passenger must declare the investigational medical devices to a DIAN agent and go through the nationalization process at the airport in Colombia. Once the passenger attempts to nationalize the investigational medical devices at the airport, one of the possible outcomes is that a DIAN agent could question the passenger, hold the investigational medical devices and force the importation modality to an ordinary importation which will require a customs broker and will take the time specified in option No. 1 above. 

bioaccess recommends modality No. 01 (ordinary importation).

Questions About Travel to Colombia

Is it safe to travel to Colombia?

The quick answer: yes—Colombia is absolutely safe for travel. Like anywhere else in the world, there are areas that are fine and areas that aren't. But overall, Colombia is a traveler-friendly destination and very safe for visitors. Most likely, you will be traveling to Bogotá, Medellín, Cali, Barranquilla, or Cartagena. These are the main cities in Colombia, and they all have modern airports with safe taxi service to your any hotel. Besides, for your initial trip to Colombia, a team member from bioaccess™ will pick you up at the airport and accompany your at your chosen hotel. This will give you extra piece of mind about your safety and will show you how safe it is to travel to Colombia.

About 4.5 million tourists visited Colombia in 2019. This represents an almost 8% growth over 2019. As a matter of fact, Colombia was chosen as the number one trending destination for tourism in 2020 in a ranking by the United States Tour Operators Association (USTOA). Read more.

Colombia is quickly becoming one of the most attractive investment destinations in the world. In December 2019, the Colombian government announced over USD $1 billion in foreign direct investments (FDI) in 2019; this represents a 100% increase from that the country received in 2018. This shows the interest international companies have in the business opportunities Colombia has to offer. The doubling of the number of investors, when compared to 2018, ratifies Colombia as one of the most attractive and safe investment destinations in the world. Read more.

How do I travel to Colombia?

Five U.S. airlines provide non-stop, daily flights between Colombia and the United States: Delta (from Atlanta and New York City), United Airlines (from Houston and New York), American Airlines (from Miami and Dallas), Spirit (from Fort Lauderdale), and Jet Blue (from Orlando and Fort Lauderdale). Non-U.S. airlines (Copa, LATAM, Viva Colombia) also operate on some of these routes. Colombian airline Avianca provides non-stop flights to Miami, Fort Lauderdale, Orlando, New York, Washington-Dulles, and Los Angeles. If you are a US citizen, you won't need a visa to enter Colombia and visit for up to 90 days.

Miscellaneous Questions

What are the reporting requirements for a medical device clinical trial in Colombia?

You must comply with the technovigilance reporting mandated by the IRB/EC at the research site you plan to conduct your trial, and by INVIMA. The report to INVIMA must be sent using this form.

1. Serious and non serious adverse events (as they occur)

2. Follow-up (every six months)

3. Final device usage accountability report (end of the study)

4. Study close-out

Source: INVIMA

Does Colombia have any clinical trial registry or database where the trials conducted in the country are available for public view?

Colombia's INVIMA has a list (in Spanish) of trials that it has approved. See the list here.

You can also search ClinicalTrials.gov for clinical trials in Colombia.

We are working on a stem cell project, and we are starting to look at sites for our first-in-human trial work. How difficult would it be to bring stem cells from the US into Colombia for the trail?

Easy! All we need is approval from the institutional ethics committee at the site to officially start recruiting patients. We will take care of the importation process. It should be pretty fast and straightforward. 

Our product already has CE Marking, it already has marketing authorization from INVIMA, and we are already selling it in Colombia. We would like to conduct a trial on the product (for the same indication of use it is approved for) in Colombia so that we can obtain clinical data for an FDA PMA submission. Does that make our trial easier in Colombia? 

Yes! All you have to do is find a clinical research site and get your study approved at its IRB/EC. INVIMA doesn't have to evaluate and approve your study (since you already have INVIMA approval to import your product into Colombia). 

We plan to conduct a non-interventional retrospective research study in Colombia. Which agency do we need to apply for ethics or IRB study waiver or exempt status?

You will need to submit your study documents for evaluation and approval at the institutional review board (IRB or also known as institutional ethics committee) that is associated with the site/center where you plan to conduct the study. Every hospital facility in Colombia has its own IRB/ethics committee. If you want to have an official letter from the regulatory agency saying that you are exempt from their jurisdiction, then you have to contact INVIMA and submit a derecho de petición request. You will get an answer from INVIMA within 30 business days. 

What should I know about translations? 

• All documents must be translated to the "Colombian" Spanish dialect. The Spanish spoken in Latin America changes from country-to-country and INVIMA has rejected documents such as an Informed Consent Form that is not easily understood by an average native Colombian citizen.

• We recommend that sponsors translate their documents by Colombian Spanish-speaking translators certified by the Colombian Ministry of Foreign Affairs.

• A certified translator is a person who has passed the linguistic proficiency test from the relevant agency designated by the Government of Colombia for this purpose. Any translator who passes this test should take office before the Superior Tribunal of the Judiciary District and apply for a certification from the Ministry of Justice and Law, which will accredit him or her as an official certified translator. The certified translator must register his name with the Ministry of Foreign Affairs by submitting a copy of the Oath of Office and a copy of the certification issued by the Ministry of Justice and Law.

• We offer our sponsors certified translation services and works with local Colombian certified translators duly endorsed by the Ministry of Foreign Affairs (who therefore, hold the relevant certification issued by the Ministry of Justice and Law) with past experience in the clinical research industry. This will ensure that our sponsor's translations as accurate, faithful and valid to be presented to any government agency such as INVIMA.

• Although INVIMA doesn’t specifically require that sponsors submit documents translated to Spanish by official government-certified translators, it’s customary —and expected by the recipient of the document— in Colombia that all translations (both in private business and government dealings) are done by government-certified translators.

• Just like there are differences in English expressions, spelling, industry and business terminology among English-speaking countries (USA, UK, Australia, Canada, etc.) Spanish varies throughout Latin America. Colombian Spanish has its own peculiarities just like Mexican or Argentinian Spanish have. For Colombia’s INVIMA purposes, this is important in two ways: a) the evaluation committee members should be able to easily understand the protocol, the investigator's brochure (IB), and all other study-related documents, and b) the patient's informed consent form (ICF) should be written in such a way that an average Colombian native citizen is able to easily understand (there have been cases where the committee has rejected ICFs for being written in non-Colombian Spanish).

• A printed document that has been translated by a certified translator in Colombia will have (by law) the following elements:

  • A "Certified Translation" header.

  • A consecutive certified translation control number.

  • The seal of the official translator in which the translator's full name, his or her certification number issued by the Ministry of Justice, the certification issue date, and the languages that the translator is certified to translate.

  • The signature of the translator in the last page, or at least, the initials of the translator if the document has several pages.

Through a seal and a signature, the translator certifies that the translation is correct and complete and takes responsibility for what is translated. This way, the translator basically acts like a notary authenticating a document. A certified translator is also authorized to be an official interpreter, translating declarations and  affidavits before a notary or a judge.