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
Veristat_icon_gene therapy Demand more complex clinical program planning
Veristat_icon_regulatory approval Can depend upon the selection of the right regulatory pathway
Veristat_icon_enrollment Often use non-randomized or natural history trial design
Veristat_icon_implementation

 

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 Experience across classifications


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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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

 

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



Learn More with These Resources

Case Study

First Gene Therapy Approved in Europe

Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in ...

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Published Article

Overcoming Challenges in Orphan Drug Development

While there is no ‘out-of-the-box’ roadmap for orphan drug development, through a toolkit of innovative solutions, we can address the unique aspects of clinical development ...

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Webinar Video Replay

What is the Future Landscape of Cell & Gene Therapies?

Historically, cell and gene therapies have been used to cure rare and ultra-rare diseases. With new efficiencies on the horizon, what does this mean for the future of these ...

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