veristat Infographics

  1. Successfully Prepare Structure-Data Files For Regulatory Submissions 8/31/2023

    Review the guidelines for creating an SD file and the updated process for submitting to the FDA's KASA review program to best prepare regulatory submissions.

  2. FDA Meeting Types With CDER And CBER For Biosimilar Products 6/7/2023

    Get a summary of the different types of meetings under BsUFA for biosimilar products, including their applicability, examples, and the timing parameters of each meeting type.

  3. Enhancing Trial Efficiency With Thoughtful Database Design 2/17/2023

    Better understand the key considerations that should be discussed prior to designing a clinical trial database, all of which can impact the efficiency of the clinical program.

  4. Autologous Vs. Allogeneic Cell And Gene Therapies 1/17/2023

    There are two types of cell therapies in development: autologous and allogeneic. Each provides distinct clinical and production advantages and challenges, and therapeutic capabilities.

  5. Shortening Development And Approval Timelines For Medicinal Products 12/7/2022

    Discover a strategic regulatory plan and leverage the right pathways to drive faster and more efficient drug development.

  6. Lessons Learned For Better Planning Of Decentralized Clinical Trials 9/9/2022

    Planning a decentralized clinical trial brings with it new challenges to overcome. Learn how to navigate this novel approach designed with a custom virtual ecosystem to satisfy both study and patient needs.

  7. Similarities And Differences Between The CTA And IND 9/9/2022

    Utilize this infographic when considering the purpose, content, and procedural similarities and differences between the Clinical Trial Authorization and Investigational New Drug Application.

  8. When And Why To Hold A Pre-IND Meeting With FDA 9/9/2022

    While a pre-IND meeting with the FDA is optional, discover why it is recommended that all drug developers planning to submit an IND to the FDA have one.

  9. Guidelines For Response Criteria For Use In Oncology Trials 5/31/2022

    Maintain consistency at sites and across sites, as well as limit any site bias, by using Response Evaluation Criteria in Solid Tumors (RECIST) when evaluating tumor response.

  10. What Is An IND And Why Do I Need One? 8/30/2021

    This infographic explores the purpose of the IND, their types, the format, what the FDA really cares about, and how the applications are approved by the FDA.