Innovative Minds....Creative Solutions....Clinical Performance
Biostatistics
Jubilant Clinsys Inc.'s global team of biostatisticians and programmers offers the following services as part of our full clinical trial management. Individual services can also be contracted.
- Review of the protocol's statistical section
- Determination of the number of displays needed
- Review of macro timelines
- Generate randomization schedule
- Review Case Report Form
- Review Data Management Plan
- Develop draft SAP (including a table of contents for displays)
- Develop Mock Shells of Tables/Listings/Graphs (TLGs)
- Collaborate with client to approve SAP and TLG shells
- Creationof Analysis Dataset Specifications
- Programming and Validation of Draft (Blinded) Datasets and TLGs
- Communication of any Data Issues to Data Management
- Generation of Draft Displays for Blinded Data Review Meeting
- Participate in DB lock and Unblinding of Treatments
- Generation of Final Displays for Inclusion into Clinical Study Report (CSR)
- Ensure the Statistical Sections of CSR are Appropriate
- Review CSR
- Draft Manuscripts, Abstracts, etc.
- Attend/Present at Investigator/FDA meetings/Advisory Committee Meetings/ Conferences