veristat Infographics

  1. 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.

  2. 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.

  3. 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.

  4. The DCT Continuum: Finding The Right Model And Right Fit For Small And Mid-Size Sponsors 7/14/2021

    The clinical trial landscape is continually adapting its focus on patient-centric practices to improve clinical trial participation by reducing patients’ burden. By leveraging virtual trial tools and strategies, you can support a patient-centric approach and continue to deliver efficient and superior quality clinical trials.

  5. FDA Meeting Types: Timing, Purpose & Examples Of Type A, B & C Meetings With CDER And CBER 4/27/2021

    Meeting with the FDA to discuss your development plans can help reduce both costs and time to approval. To meet with the FDA, you will need to decide on your preferred format for the meeting and submit a formal meeting request accompanied with or followed closely by an informational package. View our FDA Meeting Types Infographic to learn about Type A, Type B and Type C meetings – with specific insights into meeting timing, purposes and examples of each type throughout development.

  6. FDA Expedited Pathways 4/27/2021

    The FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies. This infographic highlights the benefits of, qualifying criteria for, and timing and procedures for six different expedited programs and designations. Overall, the purpose of these regulatory pathways is to save time and reduce the cost of bringing therapies to market for serious conditions and unmet medical needs.

  7. The Time For Virtual Trials Is Now 4/27/2021

    Over the past few years, this shift has focused on the idea of bringing the clinical trial to the patient's home, an evident disruption of trial conduct today. Download the infographic to learn how virtual trials are defined, the tool kits required to run a virtual trial, examples of what the patient experience can look like, and an understanding of the benefits that ultimately improve clinical trial efficiency.  

  8. Considerations For Natural History Studies 11/17/2020

    One of the cornerstones of developing therapies for rare diseases is the use of natural history (or noninterventional) data to help inform the clinical development process. Though you may think natural history studies aren’t relevant or valuable to your clinical program, natural history data can play a surprisingly helpful role in the clinical development process, with many potential uses and benefits.

  9. Benefits Of A Central Site Model 11/2/2020

    A centralized site model allows patients to be treated at one or two central sites, which minimizes the travel burden on patients and caregivers. A combination of technology and/or mobile staff are employed to conduct follow-up visits in a convenient local setting or at the participant’s home. Benefits include greater consistency and operational efficiency that is more manageable and save costs.