Maximize effectiveness and reduce adverse effects with comprehensive data analysis during clinical pharmacology drug development.
Deep level insights into the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of a drug will help with dose, route, and schedule of administration design. Comprehensive data analysis ensures maximum effectiveness while reducing adverse effects and time to market.
Optimize development outcomes
We provide expert support across the full drug development cycle. Our detailed knowledge of complete Clinical Data Interchange Standards Consortium (CDISC) requirements ensures your PK/PD data analysis complies with relevant regulations, delivering trial efficiencies and time saving in final data submissions to regulatory authorities.
We offer:
- Input on protocol and study design
- Statistical Analysis Plan (SAP) preparation
- Tailored interim PK analysis and reporting, including support towards safety meetings, either blinded or unblinded
- PK data analysis such as Non-compartmental PK analysis and Inferential statistics on PK parameters (group comparisons, BA/BE, dose proportionality, food effect, etc.)
- PD data analysis such as Immunological response, large range of biomarkers, PK/PD relationship
- PK and PD data transfer. Providing the Study Data Tabulation Model (SDTM) CDISC compliant PP dataset and the Analysis Data Model (ADaM) CDISC compliant datasets for PK and PD (e.g., ADPP and ADPC)
- PK and PD Tables, Listings, Figures (TLFs)
- PK and PD reporting
Why choose PK and PD data analysis services from SGS?
We are recognized as the benchmark for quality and integrity in clinical trial design. In combination with our biostatistical and medical writing services, you will benefit from trial efficiencies and save time with final data reporting.
