Our consultants have decades of experience in Biometrics. There are many roles we can play and tasks we can contribute to, depending on the needs, experience and availability of your Biometrics staff.
Biostatistics
Typical projects include:
Writing or reviewing the statistical section of the protocol
Writing or reviewing the statistical analysis plan (SAP)
Creating ADaM data specifications
Annotating mock-ups of tables, figures and listings (TFLs) to provide a precise specification of analysis variables and their methods.
Integrated Summaries of Safety and Efficacy (ISS and ISE)
Companies frequently call upon us to write statistical analysis plans and perform analyses for integrated summaries of safety and efficacy. Depending on the client’s eCTD data strategy we either integrate SDTM data as the source for integrated analyses, or we integrate existing ADaM databases. Either way, we use standardized datasets to facilitate pooling.
