Please Wait...

Improving Clinical Trial Environment in Latin America: Benefit from the Right Partner to Access a Largely Untapped Population

Latin America: Benefit from the Right Partner

Latin America is a geographical region with a largely untapped population for clinical trials, and it has experienced tenfold growth in clinical trials since 2000.1 However, according to clinicaltrials.gov, there are currently only approximately 3,500 studies being conducted in all of Latin America, compared with the approximate 30,000 in the United States alone.

The population of Latin America (>626 million people) is concentrated primarily in urban areas, with many lacking access to quality healthcare. As a result, I have found that clinical trials often observe rapid enrollment, with engaged and accessible patients who typically have good relationships with their physicians. My experience also indicates that the combination of qualified investigators and site adoption of ICH GCP guidelines ensures high quality standards for clinical trials.

One downside to conducting clinical trials in Latin America has been the historically lengthy timelines for regulatory approval, study budget process and contracting. Also, local insurance payers do not always cover the costs for diagnostic tools and/or ancillary drugs and devices, making this the responsibility of the sponsor.

However, progress is continuing to be made in these areas. For example, the Pacific Alliance was formed as an economic program supporting regional integration with the free movement of goods, services, resources and people. Also, the Ministry of Health in Argentina (ANMAT) issued a new regulation in April of 2017 to shorten the timeline for clinical trial approval from 160 business days to 70 days, while Argentine Customs pledged to simplify their import process for equipment and drugs.

As improvements continue to be made in these countries, partnering with a company that has long-standing experience, relationships and site networks in the region can help navigate the current lack of regulatory harmonization and stay on top of changes. Local partners assist with communication with local regulatory and customs officials, provide hands-on support with site training of the study protocol and identify local suppliers who will store, handle and transport materials appropriately. Regional variations in language within Latin America often require support with document translation.

Bioclinica has had a presence in Latin America for 14 years and has an established site network in Latin America consisting of 13 sites in six countries. We can help take advantage of the benefits of Latin America as a site for clinical research, providing early entry before others take advantage of the larger and diverse patient base.

For more information about Bioclinica, please contact me at Lauren.Chazal@bioclinica.com.

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

BREAKING: Bioclinica Launches NAFLD/NASH Clinical Trials Practice. Helps sponsors apply medical imaging in trials t… https://t.co/JLTxoevbXU
Bioclinica (2 hours ago)
BREAKING: Bioclinica launches #NAFLD #NASH clinical trials practice, helping sponsors apply medical imaging in tria… https://t.co/eUy34LiSAd
Bioclinica (4 hours ago)
Attending the #NASH Summit next week? If so, drop by @bioclinica's exhibit to learn how medical imaging is being u… https://t.co/TNkl7ce4Sq
Bioclinica (21 hours ago)
RT @bioclinica: Sponsors conducting clinical trials in #NAFLD or #NASH are invited to join us in an upcoming webinar exploring the use of n…
Bioclinica (Yesterday)
@iofbonehealth Bravo Dr. Harry Genant, a founder of our medical imaging business & a Sr. Consultant to @Bioclinica… https://t.co/P4ChlFZS3N
Bioclinica (2 days ago)
RT @ambonehealth: The @iofbonehealth honored Dr. Harry K. Genant of @UCSFHospitals with its 2019 Medal of Achievement for his innovative wo…
Bioclinica (2 days ago)

Latest Blogs:

Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box