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 DIGECITSS. 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.
About bioaccessla
At Bioaccessla, we support in assisting startups with the execution of medical device clinical trials & offering exceptional support & guidance for your project.
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
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https://www.bioaccessla.com/services
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 DIGECITSS. 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 bioaccessla guide your Medical Device Clinical Trials in the Dominican
Republic with 20+ years of expertise. Contact us today for a consultation.
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trials-in-the-dominican-republic
Contact Us
Website: www.bioaccessla.com
Phone: +1 (305) 539-9106
Address: 1200 Brickell Avenue, Suite 1950 #1034, Miami, FL 33131