Publications
Cross-company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group
July 2021 – CPT Pharmacometrics & System Pharmacology
Ménard T, Young K, Siegel L, Emerson J, Studt R, Sidor L; IMPALA Industry Group. CPT Pharmacometrics Syst Pharmacol (2021).
Author: Timothé Ménard et al.
Completed Work Products
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.
Work Product Team Leads: Ronojit Adyanthaya and Björn Koneswarakantha
RQA Workshop on Data Analytics
The goal of the RQA Workshop Work Product Team was to engage with Industry and Inspectors in an open dialog on how Data Analytics can be used to speed up Drug Development. The workshop took place at the RQA Conference in Brighton in November 2022, and resulted in lively discussion and wide-ranging ideas.
View the summary, write-up, and video here.
Work Product Team Leads: Joanne Donald and Timothe Menard
General Resources
Case study - Leveraging analytics for remote clinical quality oversight
This case study, presented at the 2nd APEC - Asia-Pacific Economic Cooperation Roundtable Dialogue, discusses opportunities for Post-Pandemic Regulatory Innovation Convergence, such as how analytics can help detect and mitigate issues faster, reduce the burden of retrospective, time-consuming traditional QA activities and ultimately accelerate approval and patient access to innovative drugs. View the full presentation here.