Budget depends on study design; we provide a study-specific quote. Every study is priced in a written proposal.
Budget depends on study design; we provide a study-specific quote.
Our published sample budgets come from the bioaccess® rate card. Budget depends on study design; we provide a study-specific quote. The biggest drivers are per-subject site payments, enrollment pace, follow-up length and the number of sites. Chile charges no regulator fee; Costa Rica adds a 3% CONIS levy on the total study budget, the only such levy in Latin America. For line-item detail, see the sample budget page and the clinical trial calculator.
Beyond cost advantages, Latin America offers a compelling advantage in terms of trial timelines. Studies in the region can be initiated and completed up to materially faster than in the US or EU. This efficiency is largely attributable to the streamlined regulatory submission and approval processes overseen by national agencies such as INVIMA in Colombia, COFEPRIS in Mexico, ANVISA in Brazil, and ANMAT in Argentina. These agencies often collaborate or align with international benchmarks set by the FDA and ICH, ensuring high standards while facilitating quicker approvals. It is not uncommon for FIH medical device trials to reach first patient on a timeline that varies by study (we confirm it per protocol). bioaccess® has a network of 200+ PIs, contributing to rapid patient recruitment and study completion.
Regulatory and ethics fees vary by country. Chile charges no regulator fee, and Costa Rica adds a 3% CONIS levy on the total study budget. Faster reviews also cut the indirect costs of a long study setup.
While Latin America generally offers significant cost advantages, specific country benchmarks can vary. Countries like Mexico, Brazil, and Argentina are leading destinations for clinical trials, each presenting unique benefits.
For a single-arm first-in-human device study, budget depends on study design; we provide a study-specific quote. Adding a second site or longer follow-up raises the total.
These budgets, combined with faster timelines, make Latin America a strategic choice for medical device developers aiming to optimize their clinical development programs while adhering to international quality standards as mandated by regulators like FDA and ICH. bioaccess® focuses exclusively on these regions, providing unparalleled expertise and local access for its 50+ clients.
Total program cost depends on device complexity, the number of sites and patients, follow-up length, imaging, device import and logistics, and insurance. For concrete numbers, ask for a study-specific quote.
Clinical trial timelines, from study initiation to completion, can be up to materially faster in Latin America than in the US/EU. This efficiency is largely due to streamlined regulatory processes by agencies such as INVIMA, COFEPRIS, ANVISA, and ANMAT, which often provide quicker approvals without compromising ethical or scientific rigor. bioaccess® reaches first patient on a timeline that varies by study (we confirm it per protocol).
These countries offer a combination of factors: experienced investigators, diverse and large patient populations, modern medical infrastructure, and efficient regulatory bodies. Mexico (COFEPRIS), Brazil (ANVISA), and Argentina (ANMAT) have well-defined, internationally aligned regulatory pathways that facilitate quicker study approvals and execution, all while maintaining high standards.
Yes, regulatory bodies in Latin American countries, such as INVIMA, COFEPRIS, ANVISA, and ANMAT, ensure that clinical trials adhere to rigorous international ethical and quality standards. These standards are typically aligned with guidelines from the FDA and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), safeguarding patient welfare and data integrity across all studies.
Budget depends on study design; we provide a study-specific quote. Each study is priced in a written proposal.