Development-stage pharma, medtech & biotech companies struggle to find highly talented medical staff that will give them the focus and energy to complete —on a timely manner— quality, and ethical clinical research at a very competitive cost.
Colombia offers unparalleled benefits for life sciences companies such as 1) fast 30 to 60-day national regulatory approval, 2) access to a 50-million patient population with universal health coverage, and 3) 30%-50% cost saving as compared to the US and Europe.
We are a contract research organization (CRO) for life sciences companies looking to conduct their clinical trials in Colombia. We provide medical device development services, study design and clinical trial support services in Colombia including site selection, trial set-up, study project management, regulatory management, logistical management, patient recruitment, techno/pharma vigilance, medical safety monitoring, adjudication of adverse events, data management and study monitoring.
Our founder —Dr. Pedro Martinez-Clark, a Harvard-trained interventional cardiologist— envisioned a clinical development and research organization that helped innovative pharma, medtech & biotech companies reach their clinical development and research goals by partnering them with cost-effective, quality and ethical clinical research sites in Colombia —a hidden gem unknown to the life science industry— and by operationalizing their trials at these sites by providing regulatory, clinical and logistical support.
Our official presentation provides additional informatión about who we are, what we do and why we do it. Our slidedoc provides further information about the regulatory and importation process in Colombia. On April 6, 2015, CenterWatch, the leading clinical research publication, featured a front-page article about the work that our organization is doing with the Colombian government to attract innovative pharma, medtech & biotech startups to the country.
Colombia, as a top destination for pharma, medtech & biotech clinical trials, has been featured on the Biodesign site —which is the companion to the 2nd edition of Biodesign: The Process of Innovating Medical Technologies —the most important medical innovation book in the medical device development industry. The "Update" section and the Strategy Development/Clinical Strategy chapter are profiling our work to make Colombia the top choice for early-stage clinical trials. This book was inspired by the world-renowned Stanford University's Biodesign program and was written by Paul Yock, MD, director of Biodesign, and one of the most respected authorities in the industry and other collaborators.
We improve the overall well-being of humankind by being the preferred contract research organization for innovative life sciences developmental-stage companies so that we can aid in the clinical development of their life-changing innovations.
To bridge the medical innovation development gap between rich countries and Colombia.
We exist because we believe that Colombia offers unparalleled benefits for the life sciences industry to conduct clinical research trials. We provide clinical development services to innovative life sciences companies exploring Colombia as their destination for their clinical trials. Our clients are looking for cost-efficient, ethical, fast, and quality overseas research sites, and we partner them with our vast network of government-ICH/GCP-certified sites in Colombia and help them operationalize their trials in the country.
We exist because we believe that life sciences innovators in emerging economies like Colombia deserve the opportunity to bring their products to market for the benefit of patients globally. We aid these medical innovators develop their products from concept to market by providing feasibility analysis, business plan, biomedical engineering, intellectual property advisory, and clinical development services for their innovation.
What we do
Life sciences companies engage our services because they trust us to search, evaluate and select the best site in Colombia where they can conduct their clinical trial, and they trust us to operationalize the logistics of their trials by transferring to us some of their FDA-sponsor-defined obligations.
The scope of our services include,
- Data management
- Patient recruitment
- Product registration: Regulatory registration and approval in Colombia
- Colombia in-country representation: Regulatory legal representation for foreign manufacturers
- Regulatory consulting
- Medical device development and prototyping
- Study & protocol design
- Site selection
- Trial start-up
- Regulatory submission
- Study project management
- Study monitoring
- Safety monitoring
- Logistics (import, distribution, disposal, export)
Why we do it
Development stage life science companies struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality and ethical clinical research at a very competitive cost. The regulatory process of conducting a first-in-human or any type of early-stage clinical research trial in the US is very lengthy due to current FDA regulations and institutional review board processes.
This forces startups to look "outside of the US" (OUS) to conduct their foreign clinical trials (FCT) and to look for a country where they can find a competent clinical research site where they can conduct their trials. Small and mid-size life science companies have no well-defined, professional and structured process to identify OUS sites. They mostly rely on word-of-mouth to identify these sites. We are the only CRO that helps small and mid-size life science companies find an OUS clinical research site in Colombia where they can expeditiously conduct clinical trials —fast, at lower cost, ethically, and with quality.
We recognized that the country of Colombia, with a population of almost 50 million, has over 110 government-certified ICH/GCP-compliant clinical research sites, and has the fastest regulatory process in Latin America —studies can be approved by the national regulatory agency in 30 days for medical devices and in 60 days for biotech and pharma. These sites have been conducting trials for almost 30 years, and are unknown to the global life sciences industry. These are highly qualified sites that receive about 40 annual trials sponsored mainly by the top 20 pharmaceutical companies. These sites are staffed by experienced and highly trained personnel and can be made available to small and mid-size life science company in the US or Europe.
Colombia has a robust clinical research industry ready to help small and mid-size pharma, medtech & biotech companies
Colombian medicine is well-known in Latin America and the rest of the world as a pioneer and leader in health services, positioning the country as one of the most attractive destinations for medical tourism. In fact, Colombia has been working for many years towards consolidation and excellence in health services, offering a highly competitive environment with prominent strengths. According to the annual ranking of América Economía magazine, Colombia has the best hospitals in Latin America and has the largest share (42%) of the best hospitals in the region. Furthermore, the World Health Organization has ranked Colombia's health system ranks as the first in Latin America.
In 2013, Colombia exported $215 million in health services and almost 50,000 foreign patients traveled to Colombia seeking medical services; by 2032, this amount is expected to increase to $6 billion. Thanks to the alliances between the Government, private enterprises, experts and scientists, as well as through positive administrative and managerial changes, a great portfolio of medical and surgical services has been developed to provide patients with world-class, high-quality services. Learn more at the Colombian health portal. Several clinical research organizations in Latin America have reported annual growth of about 35% to 50%. It's expected that in the next few years, Latin America will double its current volume of over 4,500 trials. Clinical trials in Colombia have been conducted since the early 80s; today it receives about 100 annual clinical trials.
The Ministry of Health and Social Protection of the Republic of Colombia mandated INVIMA to issue the Good Clinical Practice Certificate to clinical research sites in Colombia that comply with its strict guidelines. The law includes a comprehensive checklist that every site must complete. INVIMA then visits every site that applies for the certificate, verifies its compliance with the resolution´s checklist and grants a GCP certificate.
With respect to whether the INVIMA Good Clinical Practices Certificate is compliant with FDA requirements, for international inspections of pharmaceutical trials, the FDA requires conducting the trials according to GCP and under the Ethics Committee approval (see FDA's document titled Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators on Attachment 5 of this folder). For medical devices, the FDA requires conducting a trial according to the Declaration of Helsinki (a requirement in Resolution 2378) and to the laws and regulations of the country where the trial is taking place.
It therefore follows that if a Colombian research site 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. We have written a document that provides further information about this.
We bridge the gap between small and mid-size life science companies looking for ethical, quality and cost-effective sites and highly qualified sites in Colombia
Our value proposition for clinical trial sponsors is built on the fact that most Colombian clinical research sites are not ready to deal directly with foreign sponsors. Clinical trials have been conducted in Colombia for about 30 years, and Colombia is one of the top trial destinations in Latin America —along with Mexico, Argentina, Brazil, and Chile. However, sites in Colombia, for the most part, do not deal directly with foreign sponsors, much less with sponsors seeking to conduct early-stage medical device, biotechnology, and pharmaceutical trials.
Several global contract research organizations (CRO) have local offices in Colombia at the service of the top 20 pharmaceutical sponsors of clinical trials. These CROs include Covance, ICON, inVentivHealth, Inc Research, JSS Medical Research, Quintiles, Paraxel, PRA Health Sciences, and PPD. For about 30 years, sites in Colombia have worked with these sponsors and CROs in a very local manner. In other words, their relationship (oral and written) is mostly in Spanish (Colombia’s English proficiency is one of the lowest in the world according to the global English Proficiency Index), and these sites get paid mostly by the local CRO in local currency —Colombian pesos. These CROs, for the most part, manage all operational matters related to a trial (i.e., regulatory affairs, logistics, study management), and they become the point of contact for all communication to and from the foreign sponsor so that the sites concentrate only on their clinical duties related to providing medical services for their pharma trial subjects. There are no large independent (non-hospital) clinical research sites in Colombia; most sites in Colombia are part of medium to large hospital institutions that have an interest in clinical research, and the other sites are independent medium to small medical practices led by one physician-owner who has a personal interest in research and has found that he can diversify his practice’s income by conducting clinical trials at its facility.
These are sites with very little English skills and with no experience doing international business (invoicing in US dollars, communicating professionally in American English, reading and international executing clinical trial agreements, obtaining importation permits, securely storing investigational medical devices, importing/exporting equipment and medical products, etc.). The local dynamics of the Colombian clinical trial industry make clinical research sites in Colombia not suitable to contract directly with international sponsors.
With multinational pharmaceutical sponsor and global CROs with local offices in Colombia, clinical research sites have very little incentives to become a world-class international operation ready to directly attract foreign sponsors. Since 2012 Colombia has received about 65% less clinical trials. Colombia's regulatory agency at the Ministry of Health —INVIMA— only approved 39 new clinical trials in 2016. By December 2016, there were 110 INVIMA-certified clinical research sites in Colombia. If we divide the number of new trials (39) by the number of sites (110), numbers tell us that each site received 0.3 trials in 2016.
For a site to break that pattern and to diversify its income beyond the trials that the local CROs propose to them, it has to look overseas to attract foreign sponsors to conduct their trials at their facility. This will require a significant personnel (with world class bilingual and research/clinical skills) and business development/marketing investment to promote their clinical research capabilities overseas. This creates an opportunity for a Colombia-focused CRO to bring new clinical research study proposals to sites in Colombia.
We bring value to the sponsor and to the site
Our value proposition for clinical trial sponsors is to become their agents to operationalize the logistics of their trials in Colombia. The typical sponsor that we attract is a small or mid-size development stage pharmaceutical, medical device, and biotechnology company typically backed with venture capital funds. These companies seek to conduct fast, cost effective and ethical clinical trials for their innovation. They are by nature, very dynamic and require speed in regulatory approval, product importation, patient screening, recruitment, and in the overall conduction of their trials.
When we manage the relationship between a sponsor and a site in Colombia, we ensure that the sponsor is isolated from the realities of conducting trials at a research site in a developing country (i.e. lack of international business and legal experience, poor command of English, inexperience with regulatory and importation processes, cultural differences).
We seek to bring to sites in Colombia world-class clinical trials with medical innovations that otherwise they would have never received by the large CROs that currently have offices in the country. These are some of the trial set-up and operational services that we typically perform on behalf of a foreign sponsor:
- Preliminary pre-trial groundwork at the site at their patient database to ensure that we have candidate subjects.
- Budget, contract drafting and negotiation with sponsor.
- Application for import permit right after regulatory approval.
- English to Spanish translations — by certified official translators and to the local Colombian Spanish dialect.
- Import and storage of medical products for a trial (at our government-certified facility).
- Inventory management with monthly inventory reports.
- Project status updates via weekly teleconference calls.
- Patient enrollment activities (patient referral campaigns, calls to patients to schedule appointments and reminders, patient transportation, etc. )
- Ongoing quarterly reporting/regulatory paperwork required by the national regulatory agency.
- Reporting to national regulatory agency and ethics committee (e.g. adverse events, quarterly reporting of patients enrolled, reporting of devices used, dispossessed, returned to the sponsor, etc.)
- Any other activity necessary to successfully conduct the sponsor's trial in Colombia.
Will data from a clinical research site in Colombia be accepted by the FDA?
For international inspections of pharmaceutical trials, 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 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.
It's fast and inexpensive to ship investigational medical products to Colombia
The United States-Colombia Trade Promotion Agreement (TPA) entered into force on May 15, 2012. On the day of implementation, over 80 percent of U.S. industrial goods exports to Colombia became duty-free including agricultural and construction equipment, building products, aircraft and parts, fertilizers, information technology equipment, medical and scientific equipment, and wood. Other benefits of the TPA include:
- More than half of U.S. exports of agricultural commodities to Colombia became duty-free, including wheat, barley, soybeans, high-quality beef, bacon, and almost all fruit and vegetable products.
- Stronger protection and enforcement of intellectual property rights in Colombia.
- Increased access to Colombia’s $180 billion services market for highly competitive American companies.
Trade barriers between the EU and Colombia were lifted as of 1 August 2013, when a comprehensive and far-reaching trade deal entered into application. The agreement opened up markets for both EU and Colombian exporters, eventually bringing annual savings of more than €500m for companies. The improved, more stable conditions for trade and investment are expected to boost trade and investment between the EU and the Andean region.