Avoid Making Mistakes with Expert Consultation
Our highly qualified scientific-minded stategists 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 (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 implementing 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)
