Anapharm’s clinical pharmacology group has more than 40 employees dedicated to providing clinical pharmacology services in support of Phase I clinical trials. Our team provides a complete array of services for studies in every phase. Our services include:
 Protocol design and development |
| QTc study design |
| Sample size estimation and randomization |
| Case report form (CRF) design |
| Database development and harmonization |
| Regulatory-compliant data management system |
| Data entry and review |
| MedDRA and WHO drug coding |
| Model dependent and independent PK analysis |
| Population pharmacokinetics |
| Pharmacodynamics and biomarkers |
| PK/PD modeling |
| In vitro/in vivo correlation (IVIVC) |
| QA/QC |
| Statistical analysis plans |
| SAS programming and statistical analysis |
| Generation of tables, listings, and figures for clinical study reports |
| Medical writing (protocols, reports, manuscripts, and submission documents) |
504 Carnegie Center, Princeton, NJ 08540