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Strategic Clinical Development Consulting
Start early and get it right the first time. Course correct with a changing landscape. Overcome obstacles within clinical development. Collaborate with the best strategists and problem-solvers in clinical development.
Veristat has helped pharmaceutical, biotechnology, and medical device firms 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.
Planning your clinical trial or development program?
"We never assume your problem is straightforward, where old solutions can be applied without careful consideration. Our approach marries strategic consulting with regulatory insights and technical expertise, bringing you informed recommendations and decisions that advance the development and approval process."
Robin Bliss, PhD
VP, Strategic Consulting
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We know there are always unknown challenges when bringing a 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.
Avoid Making Critical Drug Development Mistakes
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.
- Creation and support of IND and regulatory interactions
- Creation and continued maintenance of a Target Product Profile (TPP) and Clinical Development Plan (CDP)
- Assist 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
- 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
- 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
Learn More with These Resources
Case Study
Dose Escalation with Bayesian Strategies
Fact Sheet
Data Management Fact Sheet
Blog
Bayesian Study Designs in Early-Phase Oncology Trials