Nuventra has experience with the full range of clinical pharmacology studies needed for drug development programs. We provide insight and guidance from a scientific, clinical pharmacology, and pharmacokinetic perspective to enable the most efficient study design while maximizing data obtained from trials in healthy volunteers and patients in the target indication.
We do not enroll or dose subjects in clinical trials but our high level of experience with designing, executing and analyzing data from clinical pharmacology & PK/PD studies makes us the best option for clients needing advice in this area of drug development. With an average of over 15 years of experience, our senior consultants work directly with the client to provide expertise at all levels of clinical pharmacology and pharmacokinetic drug development.
- First-time-in-humans (FTIH) and Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Bioavailability (BA) & Bioequivalence (BE)
- Food Effect
- Drug-Drug Interaction (DDI)
- Thorough QT (TQT) Study – Cardiac Repolarization Study
- Hepatic Impaired
- Renal Impaired
- Site of Absorption
- PK sub-study in Phase 2-3
- Phase 2 & 3 Population PK
- Model Based Drug Development and Simulation