Services - part 2

Independent Data Monitoring Committee (IDMC) Support

• Provide experienced biostatistician to serve on IDMC, or provide independent statistician to support IDMC and IDMC statistician.
• Write Charter for IDMC
• Design and program trial data review tables, listings, and graphs (TLGs)
• Provide blinded and/or unblinded statistical and programming services for creation and validation of trial data and TLGs, and communicate results with IDMC
• Interact and communicate with trial sponsor and regulatory agencies per IDMC Charter

Regulatory Submission Support

• Provide assistance in managing, compiling, quality checking, publishing and maintaining regulatory submission (e.g. IND, NDA, BLA) in eCTD-format
• Provide tools to ensure regulatory submission compliance with regulatory agency technical requirements (e.g. CTD backbone structure, document type, and required files)
• Provide dedicated server for secure data/document transfer to and from client, via VPN
• Arrange for regulatory support for agency communications through partnering regulatory firms.

Project Rescue

For situations where projects are behind the time line and need rapid response assistance, will quickly assemble and deploy highly knowledgeable and experienced personnel, to get the project back on track.

Development of Customized Applications/Systems

• Customized statistical reporting systems.
• Customized SAS macros and utilities/tools for publishing and eSubmissions.
• Statistical modeling and analysis on large datasets, such as for health-economics research, market research and survey data.

Services - part 1   |   Services - part 2