veristat Infographics

1. How Does RWE Impact Clinical Trials? 4/10/2025

   Explore the growing impact of Real-World Evidence (RWE) on clinical trials, particularly in rare disease research.

2. FDA Guidance On The Use Of DMCs In Clinical Trials 9/4/2024

   Gain an overview of FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials and their critical role in safeguarding patient safety and ensuring unbiased decision-making.

3. Understanding Data Monitoring Committees 9/4/2024

   Data Monitoring Committees (DMCs) provide independent oversight in clinical trials. Discover how expertise in organizing DMCs strengthens trial integrity through rigorous risk-benefit assessments.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.