An OPIS team of experts assist clients with regulatory aspects related to clinical studies submissions (Phase I-IV, observational), medical device and nutraceutical products authorization processes.
Qualified staff provide regulatory support in compliance with local and international regulations and guidelines.
Regulatory activities include:
- Review completeness and accuracy of regulatory documents
- Prepare submission package
- Management of electronic submissions according to applicable requirements
- Support and management of ClinicalTrial.gov and EudraCT
- Ensure final regulatory authorization are granted
Site selections and Trial Start-Up
Strategically selecting the right sites to conduct clinical trials is essential to ensure the success of a trial. OPIS has extensive therapeutic specific site knowledge and experience with sites across Europe and dedicated units with local site knowledge manage.
Qualified staff provide expertise in submission, follow-up and authorization processes in compliance with local and international regulations and guidelines.
Start-up activities include:
- Country and Site Feasibility
- Site Selection
- Preparation of submission package
- Submissions to IEC/IRB and follow-up
- Review, prepare and negotiate the contracts and budgets
- Ensure final ethics approval are granted
- Ensure the contracts are fully executed