Life Sciences Pharmacokinetic and Pharmacodynamic Data Analysis
Understand drug behavior, maximize effectiveness and reduce adverse effects with Pharmacokinetic (PK) and Pharmacodynamic (PD) data analysis from SGS.
Understanding the PK and PD behavior of a drug helps with the design of the dose, route, and schedule of administration to maximize effectiveness whilst reducing adverse effects. Our specialized team includes dedicated pharmacokineticists qualified to customize the PK/PD activities in line with your needs.
Why choose SGS PK and PD data analysis?
We offer you:
- A dedicated, specialized team in charge of performing high-quality PK/PD data analysis within competitive timelines
- Complete Clinical Data Interchange Standards Consortium (CDISC) compliance of your PK/PD data analysis, resulting in trial efficiencies and time saving for reporting of final data for regulatory submissions
- Support towards safety meetings through interim PK analysis and tailored reporting, as per your needs, either blinded or unblinded
- An integrated PK/PD approach with biostatistical and medical writing services that facilitate and reduce timelines for protocol development, Statistical Analysis Plan (SAP) writing and data reporting such as the Tables, Listings, Figures (TLFs) and the Clinical Study Report (CSR)
Trusted PK/PD data analysis from a world leader
To support your phase I-III clinical studies, we offer:
- Input on protocol and study design
- SAP preparation
- Tailored interim PK analysis and reporting
- PK data analysis:
- Non-compartmental PK analysis
- Inferential statistics on PK parameters (group comparisons, BA/BE, dose proportionality, food effect, etc)
- PD data analysis:
- 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
- Providing the Analysis Data Model (ADaM) CDISC compliant datasets for PK and PD (e.g. ADPP and ADPC)
- PK and PD TLFs:
- TLFs with all PK and PD results
- PK reporting:
- Stand-alone report
- Writing of appropriate PK sections within CSR
- Using our own template or sponsor’s template
To discuss your PK and PD data analysis requirements, contact us today.