Do you agree that Predictive Analytics and centralized data management are the next-generation methodologies growing across most therapy areas in the coming years? In this webinar, Johann and Jo will illustrate the benefits of predictive analytics through real-life examples.
RBQM done correctly can greatly reduce critical findings. This webinar will provide practical hints and tips to prepare your organization for an audit or inspection.
Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
Our VP Customer Success, Georgina (Gina) Wood, and Michael Walega, Head of Centralized Monitoring at BMS, are looking forward to exchanging ideas and experiences on what actions we can undertake to influence future outcomes.
Hear what our CEO, Artem Andrianov, says about how a retrospective analysis of a completed study helps screen for pain points that highlight risk factors and critical processes to build preliminary risk history, i.e., metric results and lessons learned. And be better prepared for future studies.
We are excited to hear from our guest and co-host, Anke Mueller, how clinical trial risk management technology helped to manage the risks caused by the COVID-19 pandemic.
The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.
Our industry experts will share how to manage risk in a high-octane environment, assess risk, gain insights from retrospective analyses and critical processes and data. Don’t miss out on this chance to connect with Artem Andrianov, Ph.D., and Dr. Johann Proeve around topics that will change your clinical trial practice for the better.
Our CEO, Artem Andrianov, PhD, will be speaking at this event. Catch up with Artem in Dusseldorf!