ClinPharm Consulting is a specialized consulting firm that offers clinical pharmacology consulting and clinical pharmacokinetic (PK) services to pharmaceutical and biotech companies. We offer a unique paradigm for empowering your drug pipeline. Our business model focuses on matching PK consulting expertise with outstanding scientific and medical writing capabilities to maximize the impact of individual clinical studies on an overall clinical pharmacology program. We specialize in helping biopharmaceutical companies with minimal R&D infrastructure find scalable solutions for phase 1 trials and other emerging early phase drug development challenges, providing an unmatched combination of PK, PD expertise and robust understanding of clinical pharmacology from a scientific, regulatory, and clinical conduct perspective. The breadth of our PK and clinical pharmacology experience allows ClinPharm Consulting to be a complete resource for clients to set up their drug development programs for success.

ClinPharm Consulting typically engages clients as early as the Investigational New Drug (IND) planning stage to develop robust non-clinical and clinical pharmacology/Phase 1 strategies and then works as fully integrated, in-house PK consultants and clinical pharmacology experts to assist with the execution and analysis of those strategies. Our clinical consulting services includes rational phase 1 study design, adaptive phase 1 study design, clinical conduct services (ClinOps), and PK analysis of clinical pharmacology studies. ClinPharm also helps clients transition from non-clinical research into phase 1 healthy volunteer trials and special population studies (e.g., renal impaired, hepatic dysfunction, elderly patients, thorough QT [TQT], radiolabeled mass balance, ADME studies, etc.) in addition to transitioning from healthy volunteers into studies of patients with the target disease.

ClinPharm Consulting: Empowering your drug pipeline and setting up your drug development programs for success.