Strategic  Clinical Development Consulting

For over two decades, Veristat has helped pharmaceutical, biotechnology and medical devices firms solve the unique and complex challenges they face throughout the clinical development process.   We’ve guided clients through the planning, conduct, analysis, and reporting of hundreds of clinical trials across a vast variety of therapeutic areas. Our expert regulatory, clinical, medical and statistical consultants provide high-level strategic consulting services from IND planning through to regulatory approval.

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
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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)

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Clinical Trial Planning & Tactical Implementation

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Our experienced consultants not only help you create your strategic clinical development plan, but they provide tactical support to complete the following:

  • Develop the clinical trial design
  • Determine sample size calculations
  • Write, edit or review protocols
  • Design electronic Case Report Forms (eCRFs)
  • Write Statistical Analysis Plans (SAP) or Interim analysis plans (IAP)
  • Draft regulatory agency, board meeting, or investor presentations of the clinical development, regulatory and/or statistical plans
  • And, much more.

Veristat Works Well With Growing Firms

A current client started working with Veristat over 6 years ago as a small venture funded four person company.   Our initial engagement began with strategic consulting for a single clinical development program.    The company has grown to over 300+ employees and we have run 15 of their studies and provided representation at numerous agency meetings (FDA & EMA) over the course of this growth.   Learn how this relationship evolved to where we are now working on their first marketing application.

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Contact Our Experts Today

Learn how our experts can help you overcome your current clinical trial planning challenges.   Based on our years of experience working across a myriad of therapeutic indications, we create a flexible and customized approach for you, advising you of the risks and benefits of decision made along the clinical development pathway.    Speak with our experts to learn more.

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