Vaccines & Biologics

BSSI supports clients from discovery throughout the cycle of vaccine development and the testing and development of biologics. With broad experience in this highly diverse field, BSSI is well versed in the distinct requirements for these products.

  • Support for toxicology studies and animal studies including experimental design
  • Support for Investigator brochure (IB)
  • Assay analytics including assay qualification and validation
  • Statistical section of protocol synopsis
  • Clinical protocol and study design, including sample size calculations and randomization
  • Statistical analysis plans
  • Design of Mock Table Shells
  • SDTM and ADaM datasets following CDISC standards
  • Clinical tables programming
  • Support for Clinical Study Report (CSR) writing
  • Results reporting including summary of safety and efficacy findings