All drug development programs must characterize the effect drugs in humans from a PK and/or PD perspective as well as potentially investigate the behavior of drugs in different populations (e.g., hepatically impaired) and when administered concomitantly with other drugs. The need for an experienced pharmacokineticist is vital for all companies conducting early phase research. In addition, the ability to intelligently plan, execute, and analyze clinical pharmacology studies is critically important to the overall success of drug development programs. ClinPharm Consulting’s model of matching a pharmacokineticist with a clinical pharmacology consultant allows us to be a complete resource for clients and offer a diverse set of expert services.

We specialize in helping small biopharmaceutical companies with minimal R&D infrastructure find scalable solutions for emerging early phase drug development challenges. ClinPharm Consulting can “wear multiple hats” to fill several roles while you build up your R&D infrastructure. This approach has the advantage of giving you time to find the right permanent employees without sacrificing development timelines, as well as provides significant savings over the short term compared to hiring several full time employees. Alternatively, ClinPharm Consulting can assist on an ad hoc basis to provide cost-effective services that keep your programs moving forward.

Types of clinical pharmacology studies supported by ClinPharm Consulting:

• First-time-in-humans
• Single and multiple dose studies (MTD)
• Bioavailability
• Bioequivalence
• Dose ranging
• Drug-drug interactions
• Special populations (hepatic and renal impaired and elderly, etc.)
• Thorough QT
• Food effect
• PK/PD
• Mass balance (radiolabeled)
• Proof of Concept Phase 2 studies
• PK and PD assessments in Phase 2 and 3 studies