Frequently Asked Questions About Medical Device Clinical Trials in Colombia
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
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:
Cost: Savings are +30 percent over the same trial's cost in North America or Western Europe.
Speed: Colombia's total IRB/EC and MoH (INVIMA) approval takes 120-180 days.
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 among 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.
Patient recruitment: Colombia's population is more than 50 million. About 95 percent of the Colombian population is covered by universal healthcare.
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.
In a nutshell, what's the process to get a clinical trial approved in Colombia?
Obtain study approval from your site's institutional review board (IRB)/ethics committee (EC).
Obtain study approval from Colombia's regulatory agency (INVIMA)/Ministry of Health (MoH).
Obtain an import permit at Colombia's Ministry of Industry and Commerce (MinCIT) and ship your investigational devices to your site in Colombia.
Has the media written about clinical trials in Latin America and, more specifically, in Colombia?
Yes. Clinical Leader has articles here about clinical research in Latin America and 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) 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 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, 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 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 focus on clinical research services in Latin America.
bioaccess® is now a CRO that delivers a full spectrum of clinical research service offerings so medical device companies can succeed with their clinical trial plans in Latin America. Our promise is for Medtech companies that believe Latin America offers untapped potential to conduct clinical trials. By engaging with us, we promise you will cost-effectively get the clinical data you need in Latin America.
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).
Coordinate and attend the sponsor's pre-trial visit in Colombia.
Coordination and execution of the clinical trial agreement (CTA).
Gathering and 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): This includes gathering the local EC requirement checklist, editing, and assembling the submission package (excluding the applicable submission fee).
Study submission to the MoH (INVIMA): This includes completing the application, editing study documents to comply with INVIMA's guidelines, and final assembly (excluding the 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.
Coordinating and attending the site initiation visit and training for the 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 violations of health standards or procedures, 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 device manufacturing, marketing, surveillance, and quality assurance.
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 competent and efficient in performing the health regulation functions recommended by PAHO/WHO to guarantee medicines' safety, efficacy, and quality. 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 its latest annual list of Latin America’s top 58 hospitals, 23 were based in Colombia. That means 40% of the top Latin American hospitals are 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
Does the Ministry of Health in Colombia have a nationwide database that captures all patient encounters, procedures, prescriptions, etc. to find the hospitals with the highest patient volume 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 of capturing all patient encounters, procedures, prescriptions, etc. Colombia’s Ministry of Health (Minsalud) has three powerful databases (SISPRO, MIPRES, SISMED) that we can tap into to find answers to healthcare questions.
We can do data mining, business analytics, and user-friendly and graphical visualization of the raw data in the databases. The data in these databases covers nearly 95% of the Colombian population, 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 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 unsure if Colombia is the right place. Can you help us?
Some medical device companies needing first-in-human (FIH) clinical trials help approach bioaccess® after identifying a principal investigator (PI) in Colombia at an international conference or through their personal and business connections. This PI usually has demonstrated expertise in using the investigational device after presenting at international conferences or 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/her lead and conduct its (FIH/FIM) trial will 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 import 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. Aside 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 interest in participating in your FIH trial, we will have to find one for you—we offer site and PI selection services.
We are looking to conduct 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 a significant reduction in cost compared to conducting the trial in the US. Of course, this would only work if the FDA would accept the outside-the-US (OUS) data. Can you steer us in the right direction?
Colombia offers significant cost reductions, with savings of about 30% compared to US hospital prices. The FDA accepts overseas clinical data as long as it is acquired following ICH/GCP guidelines. All the research sites in Colombia follow ICH/GCP, and more than 140 of them are certified by Colombia's Ministry of Health.
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 (preferably bilingual) from the US 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 have already selected the site and principal investigator. How can you assist us?
If you have a site and principal investigator already selected in Colombia, we can provide you with our contract research organization (CRO) services in Colombia. We can help you with the trial set-up (e.g., a 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).
Can our company staff 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 to work at a lab on a site in Colombia. We only work with investigators in Colombia at sites 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, can a foreign physician perform the investigational procedure on subjects 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 a permit 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 apply at least 20 days before the project starts. After approving 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 into the operating room (OR) to do cases for training without any red tape or formal approvals before obtaining 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 is highly knowledgeable about 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 ensure 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 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 procedures. They 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. At any given time, every site in Colombia can only be associated with one IRB/EC.
Source: INVIMA
How many hospitals in Colombia are ICH/GCP-certified as clinical research centers/sites?
There are 140+ health institutions (aka IPS in Colombia) that Colombia's regulatory agency (INVIMA) has certified as following ICH/GCP international guidelines in good clinical practice.
Source: INVIMA
I've got another project I want to do in Colombia. One of the decision-makers is skeptical, though, that we can achieve the level of control—implant procedure and overall data quality—we need. What can you do for us to ensure quality?
Your worries are common to all of our clients/sponsors:
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.
Overall data quality:
Clinical research centers in Colombia are ICH/GCP certified, and each individual participating in research (i.e., the PI, study coordinator, etc.) is ICH/GCP certified individually. This means that the Ministry of Health ensures 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 that has 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 study in each research center. This, in addition to 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 during each implant procedure.
Questions about Clinical Research Sites/Centers in Colombia
What sites do you (bioaccess®) work with, and what are 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.
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 plan to conduct your clinical trial and INVIMA must approve any promotional material you plan to use to recruit patients.
Can a medical device 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, and a questionnaire in Typeform and activate a social media campaign on Facebook and Instagram.
Regulatory Timeline
What time variables must a medical device company 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.
Search for the principal investigator (PI) and his/her associated hospital where he/she practices and has the right patient population (aka IPS in Colombia).
Approval time of the ethics committee associated with the hospital/site/research center.
Approval time at the regulatory agency (INVIMA)/MoH.
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.
What is the IRB/EC review timeline in Colombia? Every IRB/EC has its meeting schedule. However, an IRB/EC in Colombia generally 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, others every two weeks, and others 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 you have in mind for your trial in Colombia, and its staff will tell you the meeting dates for their respective IRB/EC.
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 about every 30 days. This means the review takes about 30 days (provided 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 will you know if INVIMA's medical device committee approved your application or if it requests additional documentation or clarification before another review (and hopefully approval) at their next meeting.
Does this INVIMA timeframe include an opportunity to address and respond to questions, or will their questions be issued only after 40-45 days?
Their questions will be issued after 40-45 days. You must submit your answers before the deadline of INVIMA's next meeting.
Does INVIMA have a required time frame for responding to the sponsor's questions after they have been submitted?
No. INVIMA will review your answers and decide at their next meeting whether to approve your study.
For site selection, can you please outline the process of helping us find a clinical study site that meets our criteria? We have a list of potential investigators and sites from PubMed searches for applicable devices. What other ways bioaccess® could recommend potential sites?
Most trials fail due to a lack of patient recruitment. Starting with an investigator doesn't guarantee patient recruitment. First, we identify a hospital with many potential patients who fit your study. After this step, we contact and explain the study to their research center. If they express interest and show us the potential for subject recruitment, 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 and 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 that INVIMA approval is needed after EC/IRB approval in Colombia. Do we need a clinical trial agreement (CTA) and budget to start the process?
Timeline: The expected best case is that we initiate the study in 120 days, and the worst case is that we initiate it in 180 days.
Assumptions: Your study documents are ready for us to review, translate, and submit to the EC and INVIMA.
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 ECs do.
Questions About Clinical Trial Costs/Budget
We are a startup with investors lined up. We are finishing our prototyping stage and obtaining the capital we are raising. 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 in mind. We are new to the clinical trial space in Latin America and would like your opinion on our current plan's potential benefits and costs.
Whatever cost you were quoted in Australia, it’s safe to assume that you will save 30% to 40% on that per-patient price in Colombia.
Only after we formally engage will we 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 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 faster approval and a better chance of reaching your recruitment goals in a country like Colombia. The approval timeline in Colombia is sequential and consists 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.
This article, which 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 of conducting 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 of a medical device clinical trial project:
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), 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.
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 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 non-invasive procedures with short follow-ups, $3,000-$5,000 for moderately invasive procedures with some follow-up visits, and $5,000-$20,000 for highly invasive procedures with several follow-up visits. These fees may vary by ±25% depending on the schedule of events in your study protocol and current market pricing for healthcare services in Colombia when executing our master services agreement (MSA).
A hospital/research site in Colombia will typically not prepare and send you a detailed study budget after reviewing your study protocol. A hospital/research site in Colombia expects you (sponsor) or us (CRO) to 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 review 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 negotiate the final study budget with it.
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 much 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.
Submission fees: About $3,000 (this includes about $1,500 for IRB/EC submission and about $1,500 for INVIMA fees).
Translations (from English to Spanish): Expect to translate about 1,300 pages and pay a translator in Colombia about $3 per page. We facilitate these translations for you and invoice them at cost as a pass-through expense.
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.
Miscellaneous: Travel expenses, clinical trial insurance policy, custom agency/broker import duties/fees.
Will I receive a hospital budget before contracting your CRO clinical research services?
No. A research site in Colombia will expect you (sponsor) or us (CRO) to 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 negotiate the final study budget with it.
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 clients/sponsors, on a 10-subject study, Clinical Trial Insurance Services (CTIS) recently quoted them a premium of 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 from their 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 four weeks to get insurance through a local provider.
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 listing the principal investigator's name, clinical research sites, and physical addresses. This insurance certificate is enough to comply with INVIMA's requirements. However, we suggest our clients/sponsors 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 Document Requirements for the Approval of a Medical Device Study in Colombia
Are a fully executed clinical trial agreement/contract and budget 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 must provide all testing reports and your investigator brochure with the results.
Does INVIMA require biocompatibility tests and animal studies to 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) are not mandatory. INVIMA doesn’t specifically mention GLP in its requirements for approval of 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 be sufficient to show safety prior to proceeding with a clinical study in Colombia.
Could you provide a list of required testing that must be completed to submit to the MoH/INVIMA (e.g., EMC, biocompatibility, clinical evaluations, sterilization, summative, preclinical, 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 can be mitigated by doing device-level tests. It's up to the sponsor to prove the device's safety to INVIMA 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 for approving a medical device clinical study 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:
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.
Ship your devices to a designated free zone in Colombia.
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 you intend to nationalize in Colombia is about $2,000.
What information is needed to get an import permit for our investigational devices at VUCE within Colombia's Ministry of Industry, Commerce, and Tourism (MinCIT)?
For the INVIMA submission, you provided a detailed clinical supply list, including,
Lot number.
Reference numbers.
Quantity.
Serial numbers (if available).
The above information and a proforma invoice are 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 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 sponsors’ legal representative/registered agent/importer of record in Colombia (usually a local CRO like bioaccess) obtain 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 customs agency (DIAN).
You may carry your investigational devices into the country as part of your luggage. Still, no reputable hospital in Colombia will accept taking custody of investigational devices and implanting 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 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 to their 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 American agencies are Argentina/ANMAT, Brazil/INVISA, Canada/HS, Chile/ISP, Cuba/CECMED, Mexico/COFEPRIS, and the US/FDA. A Level 4 national regulatory authority is competent and efficient in performing the health regulation functions recommended by PAHO/WHO to guarantee medicines' safety, efficacy, and quality (read more). INVIMA has tight control over investigational drugs and devices in Colombia and works in unison with Colombia's customs agency (DIAN) to make certain no investigational product gets into the country and is 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 to the site when you need it for cases. Just tell us what specific equipment you need to bring to Colombia. At the time you submit 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 for shipping and nationalizing investigational medical devices in 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:
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.
Ship your devices to a designated customs-free zone in Colombia. The average processing time is 3-10 business days.
Process the nationalization of the devices through a licensed customs broker. The average processing time is 7-10 business days.
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 prevents 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:
The declared value cannot exceed USD 2,000.
The weight cannot exceed 50 kilograms (110.23 pounds).
The goods must not be subject to legal or administrative restrictions.
The goods must not include weapons, drugs, or other products subject to international shipping restrictions.
No more than six (6) units of the same product.
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 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 safe for travel. Like anywhere else in the world, some areas are fine, and some areas aren't. But overall, Colombia is a traveler-friendly destination and very safe for visitors. You will most likely 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 services to your hotel. Besides, for your initial trip to Colombia, a team member from bioaccess® will pick you up at the airport and accompany you to your chosen hotel. This will give you extra peace of mind about your safety and show you how safe it is to travel to Colombia.
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 globally. In December 2019, the Colombian government announced over USD 1 billion in foreign direct investments (FDI) in 2019; this represents a 100% increase from the country's received in 2018. This shows international companies' interest in the business opportunities Colombia offers. 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 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 where you plan to conduct your trial and by INVIMA. The report to INVIMA must be sent using this form.
Serious and non-serious adverse events (as they occur)
Follow-up (every six months)
Final device usage accountability report (end of the study)
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 it has approved. You can 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 trial?
Easy! To officially start recruiting patients, we need approval from the institutional ethics committee at the site. We will take care of the importation process, which should be pretty fast and straightforward.
Our product already has CE marking and marketing authorization from INVIMA, and we are selling it in Colombia. We want to conduct a trial on the product (for the same indication of its approved use) in Colombia to 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 must we apply for ethics, IRB study waiver, or exempt status?
You must submit your study documents for evaluation and approval at the institutional review board (IRB, also known as the institutional ethics committee) 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 an official letter from the regulatory agency saying that you are exempt from their jurisdiction, you must 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 into the "Colombian" Spanish dialect. The Spanish spoken in Latin America has changed from country to country, and INVIMA has rejected documents such as an Informed Consent Form that an average native Colombian citizen does not easily understand.
We recommend that sponsors translate their documents using 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 sponsor's certified translation services and work 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 are accurate, faithful, and valid for presentation 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 document recipient—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 peculiarities, just like Mexican or Argentinian Spanish. For Colombia’s INVIMA purposes, this is important in two ways: a) the evaluation committee members should be able to quickly 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 can easily understand (there have been cases where the committee has rejected ICFs for being written in non-Colombian Spanish).
A printed document that a certified translator in Colombia has translated will have (by law) the following elements:
A "Certified Translation" header.
A consecutive certified translation control number.
The seal of the official translator contains the translator's full name, the Ministry of Justice certification number, the certification issue date, and the languages that the translator is certified to translate.
The translator's signature is on the last page, or at least the translator's initials 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 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.
