Johann Proeve has more than 35 years of experience as a biopharmaceutical industry expert mostly in the former international role of Head of Global Data Management at Bayer AG. Johann is a highly sought-after, motivational speaker on topics related to RBQM and Clinical Data Management at conferences such as DIA, PCT, PharmForum, and SCOPE.
After finishing her Ph.D. in Molecular Biology, Ritwika joined Cyntegrity's project management team. Representing her clients, Ritwika manages their clinical research needs and user experience from the protocol risk assessment to the full implementation and rollout of the risk-based quality management system for their clinical studies.
"By executing retrospective analyses of completed studies, I have observed how this initial step helps screen for prospective pain points and systematic errors. With the lessons learned, we can accelerate future study setup and significantly increase their successful conduct."
There's a ton of information locked up inside clinical trials. As they say, hindsight is 20-20, so why not make use of it? More and more sponsors recognize the impact a retrospective analysis has on their future studies. Can a retrospective analysis of a completed study help screen for prospective pain points, highlight intrinsic risk factors and critical processes? And how can we set our study teams up for success with the resulting preliminary risk history, i.e., metric results and lessons learned?
During this mindsON RBQM workshop, Johann and Ritwika, are looking forward to exchanging ideas and experiences on what actions we can undertake to influence future outcomes.
Can past actions affect future outcomes? Join the discussion!