Solutions

Partner of Choice for Cell and Gene Therapies

Accelerate your cell or gene therapies to market with tailored clinical and regulatory strategies and expert insights.

We understand how high the stakes are with your advanced cell or gene therapy program. Nothing is standard about study design, study conduct, or regulatory process in this specialized area. Veristat has successfully supported over 160 cell and gene therapy projects, with a global team of scientific experts who are adept at both strategy and execution across the clinical development journey.

  • >110 cell and gene therapy projects in the last 5 years
  • >25 regulatory submissions (INDs, CTAs, BLAs, MAAs) -  of which 10 are Marketing Applications
  • 3 Marketing Application Approvals to date
  • 70% are for rare diseases
  • Executed trials for the first gene therapy approved in Europe

Life-changing Work with Unique Challenges

Each cell and gene therapy is different, with a complicated regulatory approval process that is full of unknowns. Even the best therapeutic may not reach patients who need it if study design and execution are not done correctly.

Cell and gene therapies:

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Do not follow a classic route to market

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Demand more complex clinical program planning

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Can depend upon the selection of the right regulatory pathway

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Often use non-randomized or natural history trial design

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Require Long-Term Follow-Up rollover studies

Delivering Results Across a Complex Clinical Development Pathway— Getting You to Market Fast

Veristat has launched a Center of Excellence, comprised of a global team of scientific experts who offer tailored solutions from early stage through commercialization. We’re here to help you get your compound to market faster and positively impact patients around the world.

  • Accelerated clinical trial start-up and management
  • Bespoke regulatory strategies for your specific advanced therapy 
  • Comprehensive suite of solutions, including consulting, regulatory, project management, data management and monitoring

World-class regulatory and clinical insights

Confidence in your endpoints

Ability to use accelerated paths / special designations

Centralized site model / remote monitoring

Global network of sites, partners, & vendors

Expertise in logistics / handling live cell material

Supporting Any Product

No matter your product, Veristat can assist you in bringing it to the patients that need it. Veristat has extensive expertise supporting gene, cell, tissue engineering, regenerative medicine or advanced therapy clinical development trials.

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Helping You Stay on Track During COVID-19 and Beyond

  • Higher site engagement with our Centralized Site Model and remote monitoring
  • Protocol amendment expertise to speed patient recruitment 
  • Bridging data gaps with streamlined data collection / EMR approach
  • Collaboration with regulatory agencies to work through protocol deviations and study gaps

A Focus On Regulatory Can Make All the Difference

  • Pioneering: We know what works and have created new agile processes to help our clients reach approval for advanced cell and gene therapies
  • Relationship-driven: We maintain strong relationships and interactions with key global regulatory agencies
  • Moving quickly: Expertise in all accelerated pathways to approval, and in applying and retaining special designations 
  • On top of changes: Ongoing regulatory engagement to keep up with the constantly changing landscape for advanced cell and gene therapy products

Learn More with These Resources

Podcast

Use of PRO In Cell and Gene Therapy Studies

Podcast

Real-world Considerations When Administering Advanced ...

Podcast

Planning the Way Forward in Neurodegenerative Disease ...