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
