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.
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.
Key Data Goes Here
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
Strategy isn't a one-time decision, it's an strategy we help you get right 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.
Veristat Expertise in Strategic Consulting
We know there are always unknown challenges when bringing novel therapeutics to market, so we've assembled an extraordinary team of scientific minded experts who have mastered the complexities of therapeutic development enabling sponsors to succeed in extending and saving lives.
“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
- 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
Clinical Trial Planning & Conduct
- 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
Regulatory Strategy
- 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 EOP2/Support regulatory interactions
- SPA/special assessments
Experienced Partners Help Create Your Clinical Development Plan with the Endgame in Mind
At Veristat, we provide solutions to support developing and delivering life-changing therapies to patients in need. These solutions span all phases of development and a broad range of complex therapy areas for any clinical, regulatory, or commercialization program.
PROOF & RESOURCES
Experienced People at the Table
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