News
Pink Sheet Regulatory Analysis: CRDSA’s External Controls Roundtable
Aaron Mann2023-08-24T14:42:26-04:00August 24, 2023|
This Pink Sheet analysis (subscription needed): “US FDA’s External Controls Guidance Should Include Hybrid Designs, Experts Say” provides an in-depth recap of the CRDSA’s July 19th roundtable.
Can Doctor AI predict cancer, save lives?
Aaron Mann2023-08-20T17:32:00-04:00August 2, 2023|
This Al Jazeera “Big Idea” feature highlights the AI data challenges: “Central to the challenges confronting AI in medicine are three major limitations in the data used to develop it: paucity, access restrictions and quality” and calls out CRDSA’s work to drive change.
Assessing Innovation: How Pharma Makes Tech Investment Decisions
Aaron Mann2023-08-10T18:04:56-04:00July 15, 2023|
Read Bio-IT World’s write of the plenary keynote panel that featured CRDSA Board Director Peter Mesenbrink (Novartis) and was moderated by Aaron Mann.
Establishing a Basis for Secondary Use Standards for Clinical Trials
Aaron Mann2023-03-15T22:49:35-04:00March 8, 2023|
Applied Clinical Trials Online has published CRDSA’s paper “Establishing a basis for secondary use standards for clinical trials.” The paper reports on CRDSA’s 2022 survey of biopharma and academic researchers, and discusses how common standards can accelerate the reuse of trial data, benefiting both data contributors and the research community. CRDSA recognizes the incredible contribution of the authoring team including: Ernest Odame (Takeda), Tracy Burgess (Roche), Luk Arbuckle and Andrei Belcin Privacy Analytics), Peter Mesenbrink (Novartis); and Ramona Walls (C-Path)
Regulatory Focus Interview on CRDSA’s Supplemental Controls Demonstration Project
Aaron Mann2023-03-16T16:42:11-04:00February 15, 2023|
Regulatory Focus, a publication of Regulatory Affairs Professional Society (RAPS), interviews CRDSA CEO Aaron Mann and COTA Healthcare’s Chief Medical Officer C.K. Wang, MD, on CRDSA’s demonstration project that seeks to establish best practices around the use of clinical trial and real-world data (RWD) in building supplemental control arms.
Webinar Recording Now Available: “Mind the Data Sharing Gap: Navigating Sponsor Policies and Data Protection Methodologies”
Aaron Mann2022-11-10T18:54:48-05:00October 11, 2022|
The recording of the webinar, “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies” is now available. The webinar featured the authors from CRDSA’s white paper, exploring the papers findings, which examine sponsors’ data sharing policies and protection methodologies as well as reflections on actionable steps for sponsors and secondary analysis researchers alike.
Events
PHUSE EU Connect 2023
November 5 - November 8
PHUSE will be hosting EU Connect 2023 in Birmingham, UK at the International Conference Centre, 5–8 November. This event will allow attendees to connect with impactful speakers, explore new perspectives [...]