Results Analysis & Design of Follow On Work

As data from nonclinical studies become available, it is important to assure clear and insightful data presentation in study reporting.  Report templates are a starting point that can and should be modified to enhance understanding of the study data.  For example, temporal aspects of responses can be important in comprehending the activity of a substance.  These can be obscured when the emphasis of a report is on simply counting events.  Our consultants will work with CROs to optimize data presentation (especially within the body of the report) to describe important distinctions in the data.  Our experts work with the CRO’s study directors in preparing the draft and final study reports, reviewing and incorporating comments, and interpreting the data to support the conclusions of the study.  Our goal is to ensure the details of the nonclinical study results are presented in a clear and concise manner with the knowledge of what clinical milestones the studies are supporting.

Once study data are available, our nonclinical consultants possess the necessary background and experience to recommend follow up/supplemental studies as needed.  All of this is done with the client’s clinical milestones in mind and the FDA expectations for the appropriate studies.

Our services include:

  • Review and evaluation of draft and final study reports to ensure key pharmacology, pharmacokinetic, and toxicology issues unique to the substance tested, the indication, and the intended patient population are addressed
  • Design of follow-up studies to clarify significant findings
  • Establish a comprehensive plan for target or toxicity biomarker exploration, selection, and development based on product class and existing product-specific data including identification of CROs with relevant testing capabilities
  • Review existing nonclinical programs to identify data gaps, and product strengths, weaknesses, opportunities, and threats
  • Literature search and review to assess publicly available supportive data
Interested in learning more about our services and how we can help ensure your nonclinical drug development program is compliant with all of FDA’s rules and regulations? Contact us today to learn about our unique approach, which combines deep scientific expertise with vast regulatory knowledge and experience, has helped our clients achieve successful interactions with the FDA for the past 36 years.