CRO South America
Clinical Research in Latin America
Historically, most clinical research has been concentrated in developed nations. This trend is obvious from the geographical distribution of clinical research publications.
Most of the publications and the research itself, come from North America and Western Europe.
Nevertheless, the presence of clinical research in Latin America growing steadily in the last decade, mainly because of cost effectiveness, excellent patient recruitment and the emergence of FDA approved regulatory agencies.
CRO South America
Cohortias - Full Service Clinical Research Organization based in Latin America
Cohortias has built a broad network of sites, physicians, investigators and regulatory experts across the Latin American region. This peer-to-peer model allows us to expedite our clinical trial services from the start-up phases all the way to the study termination.
Our experience in the region enables us to understand and comply with local regulations, customs, and language differences and to efficiently work with the culture and the medical practices in each country of the region.
Cohortias ensures superior trial compliance and expeditious patient enrolment. Our local footprint also enables us to provide sound advice to our clients on how to prevent difficulties and delays in the implementation and development of the trials.
CRO South America
The Potential of LATAM
Cost Effectiveness
- There are huge financial gains associated with conducting clinical research in Latin America, with up to 50% lower costs when compared to the USA.
- This is in part because of the materials and actual cost of location for LATAM research centers are less expensive and does not compromise standard-of-care or data validity.
Patient Recruitment
- With a population of 600M+, LATAM is one of the less exploited regions for patient recruitment when compared with saturated major centers in the USA and Europe.
- The lack of clinical trials and the strong bond between patients and physicians, make Latin America fertile ground for patient recruitment and retention.
Regulatory Agencies
- During the last decade most of Latin American countries have opened agencies and adopted new regulations that adhere to the FDA’s international standards.
- That is why it is crucial to have a local CRO with the expertise to navigate this changing landscape, and locally-based teams with staff who speak the language, which can save a lot of time during the study start-up phase.
CRO South America
LogicBio Therapeutics, Inc., a clinical-stage genetic medicine company, today announced clinical trial results demonstrating the first-ever in vivo genome editing in children. Early data from the company’s Phase 1/2 SUNRISE clinical trial showed measurable levels of albumin-2A, a technology-related biomarker indicating site-specific gene insertion and protein expression. The SUNRISE trial is evaluating the safety, tolerability, and preliminary efficacy of LB-001, the company’s investigational, single-administration genome editing therapy, in pediatric patients with methylmalonic acidemia.
These results follow a recommendation from the independent Data Safety Monitoring Board overseeing the SUNRISE trial to continue the study without modification. The DSMB’s recommendation was based on an evaluation of the safety data from the first two patients enrolled in the trial. Per the FDA-cleared protocol, albumin-2A detection together with the DSMB continuation recommendation enables LogicBio to begin enrolling two patients in the higher dose cohort (with ages ranging three to twelve years old) and two patients in the lower age (six months to two years old) cohort at the lower dose of LB-001.
“We are very excited to have achieved this significant milestone in the field of genetic medicine,” said Fred Chereau, president, and chief executive officer of LogicBio. “These early data indicate that we can precisely edit hepatocytes in vivo to treat a genetic liver disease with a single intravenous infusion using our proprietary GeneRide technology. Today’s announcement is a demonstration that homologous recombination genome editing without the use of nucleases is a potential alternative to genome editing technologies in development that use nucleases, such as CRISPR. The ability to insert the correct version of a gene in a cell’s genome without nucleases is an important step to unlocking the potential of GeneRide to treat a larger number of genetic diseases.”
SUNRISE is a first-in-human, open-label, multi-center, Phase 1/2 clinical trial designed to assess the safety and tolerability of a single intravenous infusion of LB-001 in pediatric patients with MMA. LB-001 is designed to non-disruptively insert a corrective copy of the MMUT gene into the albumin locus to drive lifelong therapeutic levels of MMUT expression in the liver. LB-001 is based on the company’s proprietary GeneRide technology, which uses homologous recombination, a natural DNA repair process, to enable precise editing of the genome without the need for exogenous nucleases and promoters that have been associated with an increased risk of immune response and cancer.
“MMA is a rare, life-threatening genetic disorder for which there are no treatments addressing the underlying cause of the disease. By demonstrating for the first time ever that in vivo, nuclease-free genome editing in pediatric patients is achievable, we are one step closer to bringing a safe and effective genetic medicine to children suffering from MMA and, potentially, other early onset genetic diseases where early intervention is critical to achieve optimal health outcomes,” said Daniel Gruskin, MD, chief medical officer of LogicBio. “I would like to thank the patients, their families and the investigators who are participating in this landmark trial. We look forward to continuing to progress the clinical study to better understand the biochemical and clinical effect of this genome editing therapy.”
The Company remains on track to present additional interim data by the end of 2021.
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CRO South America
Why Latin America?
Several factors contribute to Latin America being a region of choice to conduct your clinical trials:
Patient Access
Compliance & Retention
Lack of Language Barrier
disease prevalence
CRO South America
The Need of a Local CRO
Continued consolidation in the industry by global CROs has made this need more apparent and even more acute.
Working with large global CROs, with inflexible one-size-fits-all procedures, global blended rates and disregard of local/regional idiosyncrasies, drug development companies are not able to fully unlock the tremendous potential that Latin America can offer.
As a local based CRO, Cohortias fills this gap providing development companies, as well as other CROs, the opportunity to work with a credible regional niche CRO provider in Latin America.
As part of the region, we are able to more efficiently contribute to international clinical development programs, both in terms of recruitment and quality, whilst simultaneously offering key benefits of Latin America, such as; low costs and fast timelines.
