Clinical Study Strategy and Design
Our focus and expertise in clinical pharmacology and its role in drug development is our differentiator. Clinical study strategy is about much more than one study, it’s about an integrated approach to designing, conducting, analyzing, and interpreting data within the context of your overall drug development program.
The collection of relevant and high-quality clinical pharmacology study data requires both robust protocol design and experienced study oversight. Careful planning with the help of clinical pharmacologists or pharmacokineticists is crucial to make the most of the data collected. As part of any study design, your clinical pharmacology strategy should establish an understanding of existing data and how to maximize the impact of the next study on the overall plan and ultimately, the product label.
Allucent has deep experience in delivering the study rationale, design, dose(s) justification, participant population rationale (diversity), PK and/or PD sampling strategy, pharmacogenetic sampling, analysis plans, interpretation, and reporting of data for clinical trials across all phases.
Clinical Study Strategy and Design Services:
- Clinical pharmacology development strategy
- Study design and protocol development
- Dose rationale and dose administration
- PK and PD sampling schedule
- Inclusion/exclusion criteria
- Robust PK and PD analysis
- Medical/Clinical monitoring
- Biostatistics and data management
- Clinical study report (CSR) and/or standalone PK report
- Documents that are eCTD-publishing ready
- Post-study update (if necessary) to clinical pharmacology strategy
- Contribution to Pre-IND, Briefing document, IND/NDA modules’ writing
- IB, Label and Safety update
Clinical Pharmacology Studies Supported:
- First-In-Human (FIH), Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
- Proof of Concept and Larger Dose Ranging
- Thorough QT/QTc (TQT), including cQT analysis
- Relative Bioavailability and Pivotal Bioequivalence
- Drug-Drug Interaction (DDI)
- Food Effect
- Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)
- Renal Impairment and Hepatic Impairment
- Pediatric and Elderly
- Site of Absorption
- Radio-Labeled Mass Balance