How to Navigate Medical Device Trials in the Dominican Republic
Clinical trial management for medical devices may appear complicated, but it doesn't have to be that way in the Dominican Republic. For our clients wishing to test their medical equipment in the Dominican Republic, this article offers a summary of the essential procedures and factors to take into account.
Identifying Local Investigational Sites
The first step is to work with experienced local Clinical Research Organisations that have long-standing relationships with top investigational sites in the Dominican Republic. These expert partners can introduce you to qualified clinics and hospitals that have conducted previous device trials and have demonstrated a commitment to complying with international clinical research standards.
Navigating the Ethics Review Process
All Medical Device Clinical Trials in the Dominican Republic must obtain ethical approval from both a local Institutional Review Board and the government body known as CONABIOS. Our clinical research experts are well-versed in guiding sponsors and CROs through both ethics review processes, which generally involve submitting a complete pre-clinical testing package, clinical investigation plan, and consent forms translated into Spanish.
Ongoing Monitoring and Support
Even the best-planned clinical trials require active monitoring and troubleshooting support. Throughout recruitment, treatment, and follow-up, our CRO maintains regular communication with sites to address any questions or challenges. Clinical research monitors make routine on-site visits for source data verification and ensure participant safety reporting procedures are followed.
Conclusion
Conducting Medical Device Clinical Trials internationally takes significant preparation and local expertise. By partnering with experienced organizations, sponsors can navigate the Dominican clinical research landscape with confidence and successfully complete pragmatic device studies on time and on budget.
Let bioaccess® guide your Medical Device Clinical Trials in the Dominican Republic with 20+ years of expertise. Contact us today for a consultation.
