Strategic Clinical Development Consulting

Start early.   Get it right the first time with the best strategists and problem-solvers in clinical development.

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.

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
clinical trial program planning

 

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)

Clinical Trial Planning & Conduct

clinical trial conduct

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.

Learn More with These Resources

Fact Sheet
Cell and Gene Therapies Fact Sheet

Nothing is standard about study design, trial conduct, or regulatory process in this specialized area. Our scientific team of experts are adept at strategy and ...

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Case Study
Complex Trial for a Rare Pediatric Gene Therapy

A clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex gene therapy. Veristat experts complimented the client’s team ...

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Infographic
Purpose of an IND

Learn the purpose of the IND, their types, the format, what the FDA really cares about, and how the ...

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