Frequently Asked Questions About Clinical Trials in Colombia

 

We can assist you with the search, site selection, and approval of planned clinical trial in Colombia. We will review your site selection criteria and study goals. Then, we will search the 110+ clinical research sites in Colombia that are ICH-GCP (certified by Colombia's regulatory agency, INVIMA) to find the ideal site and principal investigator for your clinical trial. We will then get the study approved at the site's ethics committee, and then we will get it approved at INVIMA. The next step is to obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia. Please be aware Colombian regulations prevent healthy volunteers from participating in Phase I trials; only sick patients with the disease related to the therapeutic area of your investigational products are allowed. 

This is a compilation of the frequently asked questions we receive from our customers (aka sponsors) when exploring Colombia as a clinical trial destination. 

How much does a trial in Colombia cost? 

Trial costs in Colombia are about 30-50% less than what it would cost to conduct the same trial in the US, Canada or Western Europe. Once we read your study protocol, we will be able to match your study with the right site and investigator in Colombia and obtain a detailed trial budget from the site.

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

Regardless of who sponsors/funds a trial (for investigator-initiated ones: a for-profit, non-profit, state, or federal agency; or for industry-initiated: 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, overhead of about 20%, study coordinator time, record storage, etc.). 

The costs that an industry-sponsor typically saves on an investigator-initiated trial vs an industry-initiated trial 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
  • writing and publishing the study results

On an investigator-initiated trial, 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. 

If you decide to conduct an industry-initiated trial, 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. Any CRO (including ours can give you a quote for the design of your study). You will also have to assume the other costs that I mentioned above. 

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, etc. 

I 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 me to give you an approximated cost per patient without reading the protocol, identifying the schedule of events, putting together a budget grid, and contacting sites in Colombia. This will give you an accurate idea of actual costs so that you have realistic expectations in Colombia.

I have been involved with trials in Colombia that range from $2,000 to $20,000 per patient in different therapeutic areas involving drugs and medical devices. Every trial is totally different from the other. All I can give you at this point (based on my 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 industry-initiated trials 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 fees 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 two. 

What are the requirements for trial approval in Colombia

  • Medical devices: See here
  • Pharmaceutical drugs: See here
  • Biotechnology drugs, gene therapy, tissue regenerating technologies, and other biotech products that are not classified as medical devices or pharmaceutical drugs do not need INVIMA approval; only ethics committee approval is necessary. 

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

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. 

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

In order to legally import the investigational product and additional accessories named on the clinical supply list sent with your INVIMA submission, we must apply on your behalf —for each shipment— for a separate application for an import permit approval to the Ministry of Industry, Commerce and Tourism (VUCE office). The average processing time is between 5 to 10 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.