Clinical Trial Transparency
Due to regulatory push under transparency rule, sponsors are required to disclose information regarding clinical trials. Sponsors are required to register their protocols and submit study results to international or national registries.
It is required to register all interventional studies on public registries before study start or within 21 days after study start:
- Clinicaltrials.gov: all phase 2 to phase 4 studies
- EudraCT (EU Clinical Trial Register): all phase 1 to phase 4 studies conducted in Europe. And records of Phase 1 are usually not visible to the public.
We provide subject matter expert guidance for management of protocol and result in summary registration inclusive of monthly and annual maintenance activities. We help with following disclosure activities on Clinicaltrials.gov, EudraCT, and national registries including client registers:
Our prime focus is to register First time Right and achieving 100% regulatory compliance
| Protocol registration and protocol amendment |
| Results posting and update |
| Ongoing maintenance of records (monthly and annual updates) |
| Disclosure guidance and client process development |
| End to end project management |