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Study Design and Conduct

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.

While we can conduct any Phase 1 study, 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, our senior consultants will conduct a review of your clinical pharmacology strategy to establish an understanding of existing data and how to maximize the impact of the next study on the overall plan.

Clinical Pharmacology Studies Supported:

Our 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
  • Biostatistics
  • 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

Explore Our Blog

Exposure-Response Part I: Study Design Approaches

This is Part I of our two-part exposure-response blog series. This post will give a brief introduction to the Food…

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7 Pitfalls to Avoid in Your Next Phase 1 Study

Study design and subject safety are of the utmost importance in a Phase 1 study. It is also important to…

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Understanding Adaptive Design Clinical Trials

The FDA released its draft guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” in 2010 and in so…

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