Operational Services

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

Medical Affairs

• Review of Phase II clinical trial data
• Additional Phase II trial design (if necessary)
• Preparation of synopsis and protocol for Phase III program
• Review of Phase III clinical data and assistance with preparation of study report
• Assistance with preparation/review of NDA
• Medical monitoring

Case Studies

Oncology – Jubilant Clinsys conducted a large Phase III prostate cancer trial with a complicated study design that required creative training initiatives to ensure the therapy was administered appropriately and in a timely manner. .. Due to turnover of the Sponsor’s study team midway through the study, Clinsys provided detailed orientation sessions and essential documentation to the new team. Multiple back-to-back analyses and safety snapshots required the Project Manager (PM) to implement regular reviews of data queries and listings. Sample handling was time-sensitive and the PM worked with study sites to ensure after hours coverage. The study was conducted successfully and the sponsor achieved the desired outcomes.

Dermatology – Jubilant Clinsys conducted a large Phase III rosacea study. Initially designed for 900 patients, regulatory changes mandated .. the sample size be increased to 1200 patients recruited at 60 study sites. To accommodate the new FDA guidelines, multiple training sessions were conducted over weekends at different locations to include all site staff. The study was completed with 1299 patients at 56 study sites. Successful site, sponsor and CRO audits were conducted by the regulatory agency and all timelines were achieved. The study was conducted successfully and the sponsor achieved the desired outcomes.