CA/EC Submissions

As a CRO specialized in clinical studies with medical devices, we can support you with the regulatory and EC/IRB submission 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

We truly believe in a strategic, notified body-proof and practical approach.

 

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.