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Dec 2021

Webinar | Ask the Expert

By |2021-08-25T11:51:06+00:00December 2, 2021||Comments Off on Webinar | Ask the Expert

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.

Oct 2021

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2021-10-19T07:04:49+00:00October 17, 2021|Blog, Free Infographics|0 Comments

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.

Oct 2021

5th Annual OECT Summit | Toronto

By |2021-10-01T07:31:11+00:00October 6, 2021||Comments Off on 5th Annual OECT Summit | Toronto

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.

Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2021-10-04T07:08:22+00:00September 30, 2021|Blog, Case Studies|0 Comments

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.

Sep 2021

4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit

By |2021-09-17T12:32:13+00:00September 27, 2021||Comments Off on 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit

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.

Upcoming Events

  1. Webinar | Ask the Expert

    October 28 @ 4:00 pm - 5:00 pm UTC+0
  2. Webinar | Ask the Expert

    December 2 @ 5:00 pm - 6:00 pm UTC+0

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