Open-source Package for Clinical Safety reporting
The goal of the Clinical Safety Reporting Work Product Team was to shift from manual source data verification (SDV) to a common analytics driven approach to detect Adverse event (AE) under-reporting in clinical trials. It is based on bootstrap resampling and was developed by Roche and is being explored and utilised by Merck, Biogen, Pfizer and Bayer.
Here are the links to the Code repository and documentation.
Read the news article with testimonials here.
View the November 9, 2023 Webinar here or access the slide presentation here.
(Disclaimer: All work products published by the IMPALA Consortium are released “as is.” It is the user’s responsibility to validate any information/product. Any express or implied warranties, including those to the accuracy or completeness of any information published are disclaimed. In no event shall IMPALA be liable for any direct, indirect, incidental, special, exemplary, or consequential arising in any way out of the use and/or publication of this product.)
Work Product Team Leads: Ronojit Adyanthaya and Björn Koneswarakantha