Clinical Pharmacology Strategy & Development

Collecting smart, right, relevant Phase 1 clinical pharmacology study data is the only pathway to better and straight forward development. We believe that overall development requires both robust protocol design and experienced study oversight. Careful planning with the help of an experienced clinical pharmacologist is crucial to avoid missteps in your clinical study and furthermore future overall development.

We have extensive experience with the design, conduct, analysis, and interpretation of data from many different Phase 1 clinical pharmacology studies needed for a successful drug development program. We utilize an integrated approach to designing, conducting, analyzing, and interpreting Phase 1 studies encompassing overall drug development program. As your partner, we hope to be able to understand all of your clinical pharmacology strategy and data to be able to establish an understanding of existing data and how to take full advantage of the current package and what new studies are needed to achieve a robust clinical pharmacology and development package.

Types of Clinical Pharmacology Studies we can get involved in and bring value:

• First-in-Human/Patients (FIH/FIP)
• Single Ascending Dose (SAD)
• Multiple Ascending Dose (MAD)
• Food Effect
• Drug-Drug Interaction (DDI)
• Thorough QT (TQT) Study
• Hepatic Impaired
• Renal Impaired
• Radio-Labeled Mass Balance

Our Phase I, Phase II, Development, Study Design and Study Conduct Services:

• Translational Medicine
• Clinical pharmacology strategy development/review
• Study design and protocol development including collaboration with study centers and/or CROs
• Study startup activities (SIV – study initial visits)
• Robust PK analysis and standalone PK Report
• Summary presentations to management