Veristat Case Studies

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

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

  2. 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.

  3. 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.

  4. 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.

  5. A Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial 5/18/2023

    Learn how a clinical-stage biopharmaceutical company was able to reach a unanimous decision after a safety review committee data review meeting to close Phase II and advance to Phase III.

  6. Expert IND Publishing Support For An Understaffed Regulatory Team 5/10/2023

    Discover how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team.

  7. Expertise In RNA Therapies: Client Success Stories 2/17/2023

    Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.

  8. Supporting A Sponsor From SPA Rejection To BLA Submission 8/22/2022

    Learn how the clinical trial design and the statistical foundation of the special protocol assessment (SPA), which helped drive to regulatory agreement, was transformed in this case study.

  9. New Tumor Evaluation Modality To Measure Effectiveness Of Cancer Therapies 5/31/2022

    In this case study, delve into how the team used intratumor RECIST (itRECIST) criteria as the solution to measuring the effectiveness of a novel cancer therapeutic.

  10. Gaining Regulatory Approval Following A Single-Arm Phase I/II Study 3/23/2022

    A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.