From everyone at Veristat, we wish you a joyful holiday season and a very happy new year!
As we wrap up 2023 and approach the festive holiday season, we want to sprinkle some joy by sharing some of our top downloaded assets of the year. From insightful case studies to engaging blogs, we hope these resources are valuable to you and look forward to sharing more in 2024.
Case study: Flexibility Drives Progress During a Rare Disease Gene Therapy Clinical Trial
Read about how we supported a biotech organization on their gene therapies for metabolic diseases to support their clinical study for the treatment of a rare human genetic lysosomal storage disorder. Through a collaborative partnership and a flexible operating model, our experts addressed clinical operations challenges to satisfy our sponsor's requirements at every milestone. Find out more >
Case Study: Randomized Pancreatic Cancer Phase II Trial
We partnered with a biopharma company in a multi-center Phase II study for patients with exocrine pancreatic cancer. Learn about how the sponsor engaged with our team for biostatistics and programming, data management, monitoring and site management, medical safety, quality assurance, and medical writing, leading to continued collaboration in the Phase III study. Read more >
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Case Study: HIPRA COVID Trial and Approval
Advancing a vaccine rapidly through regulatory hurdles, recruitment challenges, and the approval process to market is complex. Find out how we supported HIPRA, a European multinational pharmaceutical company, with several international studies to test the efficacy, tolerability, and safety of its RBD dimer recombinant protein vaccine, branded as BIMERVAX®, against SARS-CoV-2. Learn more >
Case Study: Agile Medical Writing Support for an NDA
Find out how we supported a clinical-stage biotech organization on their CNS disorders to support the team's biostatistics and programming needs for its clinical trial. The relationship expanded to include support for developing a New Drug Application (NDA), with one critical element being medical writing for the Summary of Clinical Safety (SCS) document, having an aggressive timeline. Learn more >
Blog: Understanding FDA's Project Optimus
Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman. The goal of the initiative is to educate, innovate, and collaborate with the oncology community to advance a dose-finding and dose-selection paradigm that emphasizes the selection of an optimal dose (or doses) in the pre-market setting. Read more >