Strategic Consulting for Drug Development
Our consultants provide you with the knowledge, foresight and expertise to make informed strategic decisions to accelerate your medical therapies along the drug development pathway. We guide your decision-making before, during and after your clinical trials are complete.
Regulatory Consulting
- Development of the regulatory strategy and submission plan to support both US and “Global” registrations
- Explore the possibility of pursuing expedited pathways for accelerated approval (e.g. Priority Review, Breakthrough Designation, etc).
- Prepare and review regulatory agency meeting requests and packages
- Attend regulatory agency meetings
- Prepare for and participate in FDA Advisory Committee meetings
Clinical and Medical Consulting
- Protocol design & clinical trial planning
- Assist with initial indication selection, incorporating “Quick to POC” and commercial considerations into study designs
- Develop Key Opinion Leaders (KOLs) and Advisory Panel Networks
- Assist with preparation for and provide representation at meetings with regulatory agencies
Statistical Consulting
- Ensure that the clinical trial's statistical design will meet the intended objectives
- Evaluate potential of implenting Adaptive Design Approaches & Planning
- Run clinical trial simulations
- Perform predictive modeling
- Assist with primary and secondary endpoint selections
- Determine which statistical approach to use (PRECISION, HYPOTHESIS, or BAYESIAN APPROACH, or something else)
