Product Development - Clinical
Clinical research is the heart of product development, be it a BA/BE study or Clinical studies in patients. IBPS offers pragmatic solutions for clinical research both at strategic and execution (through partners) levels. These services span over Phase I to Post-Marketing studies. Focus is to create high quality data in a cost effective fashion.
Medical writing
Study start-up
- Clinical trial outline
- Draft essential study documents)
- Review of CSR
study and site start-up
- Vendor selection
- Site budgeting
- Site feasibility and selection
- Regulatory submission (CTA)
- Pre SIV essential documents review (Pre IMP release)
Clinical Project Management
- Recruitment Management
- Site monitoring
- Site close-out
- Continuous vendor due diligence/oversight
Training and Development
- Investigator and study team training on guidelines and
- Need based training on industry best practices