Pharmacodynamic and Exploratory Analyses

Theradex has extensive experience supporting exploratory and pharmacodynamic studies for early phase oncology clinical trials including:

  • Investigative Products: Targeted small molecules, biologics, vaccines, and bacteria
  • Sample types: Whole blood, serum, buffy coat, plasma, tumor biopsy tissue (frozen, fixed or fresh), ctDNA, viral DNA
  • Methodologies: NextGen Sequencing, Imaging, RT-PCR, immunohistochemistry, in situ hybridization, ELISA, flow cytometry and many more

Our in-house team of scientific (PhD) and project management experts will help design your study to maximize exploratory and pharmacodynamic endpoints. Theradex will provide guidance in:

  • Scientific review of electronic data capture design
  • Regulatory issues
  • Site management
  • Data transfer
  • Clinical data review and reconciliation
  • Vendor identification, due diligence and management
  • Scientific review of interim and final data reports
  • Statistical tables, listings and files