Collection of relevant and high-quality Phase 1 clinical pharmacology study data requires both robust protocol design and experienced study oversight. Careful planning with the help of a clinical pharmacologist or pharmacokineticist is crucial to avoid missteps in your clinical studies.
Nuventra has extensive experience with the design, conduct, analysis, and interpretation of data from each type of Phase 1 clinical pharmacology study needed for an individual drug development program.
Our focus and expertise in clinical pharmacology is our differentiator. This is about much more than just conducting one study, it’s about an integrated approach to designing, conducting, analyzing, and interpreting Phase 1 studies within the context of your overall drug development program. As part of the study design phase, your clinical pharmacology strategy is reviewed to establish an understanding of existing data and how to maximize the impact of the next study on the overall plan.
What to Expect During the Study Design Phase
In the study design phase, Nuventra works with your team to craft a well designed Phase 1 study that contributes to your drug development plan. Our experts evaluate regulatory feedback and your current drug program to identify any clinical gaps and assist in generating a study overview that adequately addresses your needs for the study, with a focus on pharmacokinetics, safety, and other potential pharmacometric endpoints.
Our experts have a broad depth of experience and can provide as much or as little assistance as is needed, including writing the protocol, generating regulatory compliant data sets, and submitting all data to the FDA.
Clinical Pharmacology Studies Supported
- First-Time-in-Human (FTIH)
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Food Effect
- Drug-Drug Interaction (DDI)
- Thorough QT (TQT) Study
- Hepatic Impaired
- Renal Impaired
- Site of Absorption
- Radio-Labeled Mass Balance
Phase 1 Study Design and Conduct Services
- Clinical pharmacology strategy development/review
- Study design and protocol development
- Study startup activities
- Data management (eCRF, randomization, database build, edit check, etc.)
- Robust PK analysis and standalone PK Report
- Clinical study report (CSR)
- Study management
- Clinical monitoring
- Medical monitoring
- CDISC datasets
- Documents that are eCTD-publishing ready
- Post-study update, if necessary, to clinical pharmacology strategy
Nuventra’s consultants stand with their customers to provide clinical services from start to finish. Our team of clinical pharmacology experts can help address gaps in clinical development plans, design necessary clinical studies, analyze the gathered data, and prepare regulatory data packages for submission to relevant regulatory agencies.
If you are ready for a team that will work with you from start to finish on your study design and conduct, reach out to our expert consultants.