ClinPharm Consulting uses intelligent PK/PD strategies to position drug development programs for success. Our extensive experience with analyzing PK/PD data and interpretation of results is unmatched in the industry. Our business model focuses on matching scientific and PK/PD expertise with superior writing to maximize the potential impact of individual studies on an overall clinical pharmacology program.

Pharmacokinetic analyses performed by our highly experienced pharmacokineticists are conducted in a fully validated computing environment and with the latest PK/PD modeling software. For traditional PK analyses, we employ Pharsight Phoenix WinNonlin 6.1 for PK analysis and TLF generation, Phoenix WinNonlin Validation Suite 2.0 to validate WinNonlin in our specific operating environment, and Phoenix Connect 1.1 to allow for data outputs that are CDISC compliant. Population PK analyses are conducted using NONMEM software.

Our experience and services includes:

• Robust pharmacokinetic and PK/PD analysis of data using WinNonlin v6 (Phoenix)
• Comprehensive Population PK services.
• Authoring integrated Clinical/PK/PD study reports or standalone PK/PD reports
• Preclinical ADME and human studies.
• Toxicokinetic input into toxicology studies and TK data analysis and report writing.
• Data management services for PK data to ensure compliance with current CDISC standards.