Veristat Case Studies

  1. Pursuing Breakthrough Therapies For Rare Metabolic Diseases 2/14/2024

    Discover how Veristat’s full-service clinical trial team helped tightly coordinate a gene therapy's dosing administration and data review.

  2. Strategic Clinical Consulting Success Stories 2/13/2024

    Explore real-world examples of how the combination of strategic consulting, regulatory insights, and technical expertise can impact the development and approval process.

  3. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  4. Medical Writing Support Relieves A Burdensome Review 11/2/2023

    Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.

  5. Proof-Of-Concept Study Enabled To Drive Novel Gene Therapy Program 9/29/2023

    Unearth how a natural history trial aimed at addressing the exceptionally rare neurological disease affecting pediatric patients with no existing treatment options was executed successfully.

  6. A Comprehensive Planning Approach For Cancer Antibody 9/29/2023

    Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase I protocol for an immuno-oncology antibody.

  7. How Vaccine Clinical Trials Work 9/8/2023

    Discover how with advanced vaccine technologies, researchers can create safer and more effective vaccines.

  8. Flexibility Drives Progress In A Rare Disease Gene Therapy Trial 9/6/2023

    Learn about the deployed methods and actions that were carried out to help a biotech company address clinical operations challenges and meet changing requirements.

  9. Regulatory Publishing Expertise Across The Entire Development Journey 6/7/2023

    Learn how with expert support, three separate sponsors were able to issue flawless IND, MAA, and NDA submissions to the FDA and EMA, expediting the process of bringing their product to market.

  10. Collaboration Delivers Agility & Results During COVID-19 6/6/2023

    Learn how a European multinational pharmaceutical company gained support for several international studies to test its RBD dimer recombinant protein vaccine for SARS-CoV-2.