Medical device trials in Colombia can start in as little as 30 days.
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.”
The combination of good healthcare (95% of Colombian citizens have health insurance), an already strong clinical trial industry, stringent regulations issued in 2008 that requires sites to be certified by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) and a relatively quick and predictable approval process for launching a trial has made it a desirable clinical trial destination.
— Ronald Rosenberg, CenterWatch Weekly, April 6, 2015
Competitive costs: Savings of about 30% or more over trials costs in the US or Europe. Today’s low Colombian peso exchange rate vs the US dollar makes the country even more cost-competitive.
Fast and predictable national regulatory pathway —about 30 days for medical devices and 90 days for pharma.
High enrollment rate: A 50-million population with universal health care coverage ensures a large patient pool of all ages.
Fast product importation (free trade agreement with the U.S. and the E.U.).
Great geographical location: EST time zone, fast and direct airline connectivity from any major city.
Great healthcare infrastructure and business environment. According to América Economía magazine’s annual ranking, Colombia has the best clinics and hospitals in Latin America.
CAPABILITIES FOR ZIKA, ARBOVIRUSES AND OTHER TROPICAL DISEASE STUDIES
To date, over 100,000 suspected cases of Zika and have been reported in Colombia.
Our organization is well positioned to contribute in the fight against neglected and emerging infectious diseases, closing the gaps between the affected communities, researchers and sponsors.
Sites And Network
We maintain a wide network of sites in Colombia. Many of these sites were set up specifically to run studies in tropical and emerging infectious diseases such as Zika, Dengue and Chikungunya.
These capabilities include active/passive vigilance, field diagnostic evaluation and clinical trials as well as economic evaluations.
Since the healthcare network plays a key role in the control of outbreaks, we have developed ties with academic and government institutions in Colombia. This is especially true at the local level, where most of the impact of outbreaks is felt.
With this infrastructure in place, we can work according to the local regulations in the execution of our studies and we enjoy close coordination with government institutions. This coordination has been valuable for example, in obtaining human samples such as sera from Zika infected patients.
Our sites have different capabilities for delivering healthcare but each one has the logistic and scientific capacity to conduct studies. All of these sites are in zones that are susceptible for arborvirus transmission. The sites range from larger cities (Medellin, Cartagena) to rural and remote areas (Sierra Nevada, Calabazo). All of these sites have access to large populations at risk for Zika and other tropical diseases.
Ipsum has developed a strong group of enthusiastic and experienced researchers across several cities in Colombia. We also rely on researchers and collaborators at different levels, such as microbiologists, pharmacists and clinical research coordinators.
Rely on IPSUM’s experienced tropical disease team to deliver the optimal clinical strategy. As new therapeutics are identified and need clinical testing, our team is already on the ground and well-prepared to start trials quickly and keep them on track. With access to a large amount of affected patients, we run multisite trials in tropical areas of Colombia.
Infectious disease research goes through challenging regulatory settings in terms of clinical, statistical and safety data requirements. An investigational drug/vaccine needs to undergo various types of studies, such as, non-inferiority, equivalence, and superiority studies in varied age groups to prove itself as a promising treatment, against a particular disease prior to market approvals. Our experienced and devoted teams of experts understand these issues and provide customized solutions in accordance with the requirements of our clients. Well-equipped with the latest and most advanced technologies, we can provide personalized solutions to meet your business needs.
Infectious diseases affect more than 1 billion people, living in tropical and subtropical climates. Over 70% of countries and territories that report the presence of tropical diseases are low-income or lower middle-income economies. Our access to patients in remote tropical areas of Colombia gives us the advantage to recruit diverse populations, at a fast rate, helping us manage our client’s studies proficiently and meet objectives.
IPSUM Cardiovascular sites:
Enhancing your cardiovascular program with knowledge and in sight
IPSUM has the experience, operational capability and the resources necessary to successfully support protocol development and manage complicated trial execution.
Cardiovascular research and development is extremely vital when considering that heart disease is the number one cause of mortality worldwide. Cardiovascular drug and device development are among the most complicated therapeutic areas to navigate.
IPSUM can help design a regulatory strategy, meet with health authorities, and achieve agreement on essential study design that will lead to a successful study outcome.
Advanced clinical services for cardiovascular disease
Including stroke, heart attack and heart failure
We help your cardiovascular program accomplish:
Validated Software Development:
The U.S. Food and Drug Administration (FDA) and other international agencies require that computer software infrastructure and applications are appropriately tested for their regulated uses. Validation provides the required documented evidence through a process of planning, requirements definition, test development, test execution and final reporting. Additionally, operational procedures are reviewed to ensure ongoing compliance. Source Meridian specializes in providing full scope validation and compliance services to ensure that mission critical business systems are functional and in compliance.As a global leader specializing in providing a full scope software testing and validation services, Source Meridian helps life sciences companies ensure that key business systems are functional and in full compliance with applicable FDA and international regulations and guidelines. We understand that computer systems are a key element of a company’s risk management strategy, and aim to ensure these systems are running efficiently and accurately.
Involve our Cardiovascular Sites of Excellence
Providing local infrastructure, scientific knowledge and technological innovation for your cardiovascular studies
We identify cardiovascular investigators from our broad database. We run studies at our own sites and also collaborate with experienced, trained, and inspired partner sites. After being selected, we maintain smooth contact with study sites, guaranteeing a timely start, efficient recruitment, and strong patient retention for trials. We work with sponsors to recognize study specific risks and take appropriate measures early on.
Once the study is deployed, the program is monitored based on risk with the help of skilled CRA’s. Project managers and medical monitors also deliver supervision and efficiently pilot the program execution.
Disorders of the endocrine system and metabolic diseases are associated with complex clinical trials, due to the interconnected nature of the HPA axis (hypothalamus, pituitary, adrenal) and the liver, pancreas, and gallbladder.
Ipsum’s site network has PI’s with specialties in that include endocrinology, internal medicine and pediatrics. We have all the means to ensure a team of experts will run your study.
Ipsum has experience in Endocrine & Metabolic Diseases and Clinical Trial operation including: