Operational Services

• Project Management
• Regulatory Services
• Drug Safety
• Biostatistics
• Data Management
• Medical Writing
• Quality Assurance

Medical Affairs

• Review of Phase I clinical data
• Additional Phase I trial design (if necessary)
• Preparation of synopsis and protocol for Phase II program
• Training
• Review of Phase II clinical data and assistance with preparation of study report
• Assistance with end of Phase II regulatory meeting
• Medical monitoring

Case Study

CNS – Jubilant Clinsys “rescued” a Phase II study comparing the pharmacokinetics and the safety/tolerability of two different drug formulations in patients with epilepsy... Despite existing challenges with regulatory submissions and site management, the study team implemented a detailed transition plan that enabled the complete enrollment of the study within the sponsor’s original timeline, despite the rescue nature of the study. Positive outcomes included lower than expected screen failure rates, dropout rates, and query rates. The database was locked on time and the sponsor has returned to Jubilant Clinsys for the conduct of additional CNS studies.