Veristat Featured Articles

  1. Executing Patient-Focused Drug Development (PFDD) For Successful Clinical Development 11/2/2023

    Discover why the differences between individuals and diseases are crucial when crafting a clinical development program.

  2. Single-Arm Studies For Use As A Registrational Study In Oncology 9/1/2023

    Get a recap of what industry experts had to say about single-arm oncology registrational studies, success stories, and valuable lessons learned.

  3. Laying The Groundwork To Measure The Impact Of DCTs 3/27/2023

    Explore some of the key takeaways from the Tufts CSDD Roundtable on quantifying the value proposition of decentralized clinical trial deployments.

  4. Weighing FSP Model Suitability For Clinical Trials 3/27/2023

    Consider several key points outlined in this article when deciding if a functional service approach could better serve a clinical team and its drug development study.

  5. FDA Introduces ‘Nonclinical Tests’ Term, Signaling A New Beginning 3/27/2023

    Discover how this terminology change will require the investment of time and resources to deliver its full potential.

  6. Marketing Application Publishing Best Practices 12/7/2022

    Explore how effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market.  

  7. Autologous And Allogeneic Cell Therapies: Benefits, Challenges, And Future Prospects 10/24/2022

    In this blog, explore both autologous and allogeneic approaches, the solutions needed to optimize the development processes for commercial viability, and the future landscape of cell therapies in the rare disease space.

  8. Key Considerations For Small & Mid-Size Sponsors Conducting Decentralized Or Hybrid Trials 9/12/2022

    Read this webinar presentation as panelists share lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials’ conduct.

  9. A Paradigm Shift In Monitoring Clinical Trials 5/31/2022

    Today, the shift and the changes in how we work has affected how clinical trial monitoring is conducted and performed. Explore how re-tooling the clinical monitoring in clinical trials has become imperative.

  10. Planning The Way Forward In Neurodegenerative Disease Studies 7/14/2021

    The recent FDA guidance entitled "Human Gene Therapy for Neurodegenerative Diseases" (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.