Regulatory submissions (Ethics Committees/ Competent Authorities)
As a CRO specialized in clinical studies with medical
devices, we can support you with the Competent Authority (CA) and Ethics Committees / Institutional Review Board (IRB) submissions and communication for your medical device clinical trials. Although ISO 14155
prescribes generally the sponsor’s obligations in communicating with Competent
Authorities (CA) and Ethics Committees (EC), there are significant differences
between countries and even within countries between individual ECs, in the way
they work and what they require. National laws and regulations influence the
submission and reporting requirements and timelines. With our experience, we
can assist in efficient communication including; submission, (re-)approval,
maintenance and reporting.
Qserve can support you with:
- Compiling submission packages
- Ethics Committee submission
- Competent Authority submission
- Regulatory and EC reporting and maintenance
- Local hospital board approvals
- Submission planning and strategy
- Study amendments and study termination
Differences between countries in CA and EC/IRB requirements
can impact study budget and planning, and choice of locale study sites and
should preferably be part of your clinical strategy.
EC and CA submissions are part of the study
start-up phase. Qserve provides full study start-up assistance. If you are thinking about outsourcing more parts of your
clinical trial management, be sure to read more about our project management
services.