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STRATEGIC CONSULTING/ADVISORY

Strategic Clinical Development Consulting

Start early and get it right the first time. Course correct when the landscape shifts. Push past the obstacles clinical development throws at you. And do it all with the best strategists and problem-solvers in the field.

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Veristat helps pharmaceutical, biotechnology, and medical device companies solve the unique and complex challenges they face throughout the clinical development process. Our early, forward-looking planning can result in greater efficiency and a better understanding of key decisions and time points during your novel therapy development. Our expert regulatory, clinical, medical, and statistical consultants provide high-level strategic consulting services from IND planning to regulatory approval.
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Successful Development Programs Don't Happen By Accident; They Begin With Thoughtful Decisions And A Clear Strategy From The Start.

Every program presents unique opportunities and challenges that require scientific rigor, strategic perspective, and practical execution.

That's exactly what our team brings together. Our highly qualified scientific-minded strategists 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.

 

HOW IT WORKS

Getting the strategy right takes more than a single decision.

We help you shape and refine strategy at every stage of your program. Here’s how.

Before your trial

We help you plan your development program from the start, building a clear strategy, a Target Product Profile, and a regulatory pathway before you commit resources to the wrong path.

During your trial

As your program moves forward, we help you course-correct against a shifting landscape, from protocol design and endpoint selection to navigating agency interactions.

After your trial

We stay with you through submission strategy and regulatory approval, in the US and globally, so your program's momentum doesn't stall at the finish line.

dr Su

“Successful development programs begin with thoughtful decisions and a clear strategy. Every program presents unique opportunities and challenges that require scientific rigor, strategic perspective, and practical execution. By integrating regulatory, clinical, medical, and statistical expertise, we help teams navigate complexity, make confident decisions, and create clear pathways toward successful development and regulatory milestones.”

Dr. Zhaohui Su

Vice President, Strategic Consulting
Veristat

Veristat's Offerings

Avoid Making Critical Drug Development Mistakes

Clinical Development Program Planning
Strategic guidance on indication selection, program design, and the early decisions that shape your entire development path.
  • Creation and support of IND and regulatory interactions
  • Creation and continued maintenance of a Target Product Profile (TPP) and Clinical Development Plan (CDP)
  • Assistance with initial indication selection, incorporating "Quick to POC" and commercial considerations into study designs
  • Support of Program Review Meetings
  • Selection of dose escalation and dose optimization design
Regulatory Strategy
Target Product Profile and Clinical Development Plan creation, IND support, dose escalation and optimization design, submission planning for US and global registrations, expedited pathway exploration, and representation at agency meetings including EOP2 and SPA discussions.
  • Development of the regulatory strategy and submission plan to support both US and Global registrations
  • Explore the possibility of pursuing expedited pathways
  • Relative priority of indications or monotherapy/combination therapy
  • Assist with preparation for and provide representation at meetings with regulatory agencies
  • Advice and support for End-of-Phase 2 (EOP2) meetings
  • Support regulatory interactions
  • SPA/special assessments
Clinical Trial Planning & Conduct
Protocol design, endpoint and comparator selection, KOL and advisory panel development, and adaptive design approaches built to meet your trial's objectives.
  • Protocol design and clinical trial planning
  • Develop Key Opinion Leaders (KOLs) and Advisory Panel Networks
  • Ensure that the clinical trial's study design will meet the intended objective(s)
  • Primary and secondary endpoint selection
  • Selection of appropriate comparator
  • Adaptive Design Approaches & Planning

What's Next in the Drug Development Process

Experienced Partners Help Create Your Clinical Development Plan with the Endgame in Mind:

Regulatory Affairs

Move from strategy to execution, through IND/CTA filing, agency meetings, and marketing applications.

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Adaptive Designs:

Build the flexibility into your trial design that your strategy calls for.

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Clinical Operations

Put your trial plan into motion with recruitment, retention, and site management.

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Statistical Power

Make sure your trial is designed to reliably detect the effect you're looking for.

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Meet Our Experts

Every one of these services is backed by hands-on experience in the areas that matter most: adaptive designs, rare disease and small populations, complex biologics data, and independent safety oversight, delivered at the speed your program needs.

John P. Balser-2

John Balser

Founder, President, and Chief Statistical Officer

Barbara Balser-2

Barbara Balser

Executive Vice President, Chief Scientific Officer

Zhaohui Su color_3

Zhaohui Su, PhD

Vice President, Strategic Consulting

Gil fine

Gil Fine

Strategic Consultant, Biostatistics

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Dave Koster

Vice President, Biostatistics Consulting

PROOF & RESOURCES

Learn More with These Resources

webinar
 
Real-world Evidence for Regulatory Submissions

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Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works

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webinar

 

Days Instead of Weeks What It Actually Takes to Close the DBL-to-TLF Gap

Watch now →

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The Psychedelic Setback: What MDMA Rejection Taught Drug Developers

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Give every decision the right direction.

The decisions that shape a development program are only as strong as the evidence and thinking behind them. Veristat brings regulatory, clinical, medical, and statistical expertise together to interpret what your data means, anticipate what may come next, and shape a strategy that keeps your program moving toward its next milestone.

Frequently Asked Questions