Conference Presentation
The Role of Natural History Studies in Ultra-Rare Disease TrialsGet the Presentation that was given at the Orphan Drug Congress Europe 2021. Completing a natural history study in conjunction with an interventional study for ultra-rare ...
Infographic
Why and When to Hold a Pre-IND Meeting with FDAWhile a pre-IND Meeting with the FDA is optional, the Regulatory team at Veristat highly recommends that all
drug developers planning to submit an IND to the FDA have a pre-IND ...
Infographic
Similarities and Differences Between the CTA and INDSuppose the goal of a development program is to initiate clinical trials within European member states, the United Kingdom, or North America. In
that case, strategic consideration to ...
Case Study
First Gene Therapy Approved in EuropeVeristat 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 unexplored waters ...
Published Article
Overcoming Challenges in Orphan Drug DevelopmentWhile 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 in rare ...
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 therapies and ...
Webinar Presentation
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 therapies and ...
Infographic
Marketing Applications Approval RecordVeristat is proud to have supported the preparation of 75 marketing applications (NDA, BLA, MAA, etc) that are now approved for patients. For these approved products, direct involvement ...
Fact Sheet
Overcoming Data Analysis HurdlesLearn how to strategically migrate and produce clinical trial data outputs in submission-ready format to reduce timelines without sacrificing data quality.
