Full-Service CRO of Choice for Biologics
Advance your biotherapeutic through the clinical development journey to approval and commercial success.
Advancing biologics from start to finish is highly complex and full of challenges, requiring bold scientific strategies and implementation. This class of therapies requires versatile planning and development, from cell & gene therapies to mRNA vaccines to monoclonal antibodies and more. Veristat’s global team leverages lessons learned during our work supporting more than 250 clinical trial and consulting projects, 13 IND/CTAs, and 8 BLAs/MAAs for biologics and biosimilars in the past 3 years.
Delivering high-quality results in a timely and efficient manner is our strength. Trust Veristat to guide your success in mitigating risks and efficiently bringing your biologic towards its next development milestone, all while ensuring patient safety and access.
In the past 3 years, Veristat has conducted over 40 full-service biologics trials,
30% being viral gene therapies.
Offering End-to-End Clinical Trial and Consulting Expertise
We understand how high the stakes are for your biotherapeutic. Nothing is standard when developing novel therapies, demanding more complex clinical program planning, and involving a complicated regulatory approval process.
As your strategic partner, Veristat ensures that your clinical trial or program design supports your regulatory strategy in this specialized area. Our experienced teams are ready to plan and launch your trial:
- Full-service clinical trial planning and project management
- Clinical site management and monitoring
- Biometrics expertise including data management, biostatistics, statistical programming, and data standards implementation
- Medical writing of clinical trial and regulatory submission documentation
- Strategic regulatory consulting including tailored CMC support
- Preparation of regulatory marketing applications
Your Global Partner in Biotheraputic Development | Case Studies
Overcoming Clinical Operation Challenges in a Rare Disease Gene Therapy Clinical Trial
Learn how Veristat supported a biotech company developing gene therapies for metabolic diseases in implementing a flexible operating model to address critical patient, lab, product manufacturing, logistics, and tracking/reporting requirements to satisfy requirements at every milestone.
Positioning a Sponsor’s First
Trial for Success
Veristat supported a clinical-stage biotech company in writing their protocol and study design for their first Phase 1/2a study for an immune-oncology therapy. Learn how our strategic consultants and regulatory experts helped the sponsor with efficient trial planning.
Global Pediatric Phase 1/2 Clinical Trial Begins on Heels of Successful Natural History Study
A sponsor sought Veristat early in development for help with a Natural History trial. After its successful implementation, the sponsor moved forward with the gene therapy treatment program, which has already treated its first patients. Read how Veristat continues to provide full-service support for this Phase 1/2 trial.
Podcast: Regulatory CMC Considerations for Planning Comparability Studies for Biotherapeutics Development
Comparability studies pose a significant issue for those working in biotherapeutics development, as undetected product changes are considered high-risk. Learn the importance of comparability studies for biologics, key aspects of assessing comparability, and how to successfully plan your clinical and CMC manufacturing development plans.