Client: India based innovator

Services provided:
Vibrance provided services for the following aspects of this unique study

• Clinical Development Plan
• Regulatory strategy
• Study specific Document preparation:
  • Protocol and ICF development
  • Investigator Brochure development
• Regulatory document preparation:
  • DCGI Dossier development
  • DCGI Applications
• Regulatory Support
  • Presentation to SEC
  • DCGI Approval and Test Licence
  • EC Submission, Quety handling and Approval for the study.
• Coordination of R&D manufacturing Inspection
• Site Selection
• Coordinating and attending meetings with Funding Agencies for project updates and fund release
• Working with Central Labs for central Lab Set Up
• Coordination and managing the CDM partner.
• Designing of EDC database and CRF for the study.