About Linda Bunschoten - Chief Marketing Officer

Linda has 25+ years of experience uncovering pain points and strategizing with companies in the healthcare industry in order to secure and retain more clients. Her chief thinking responsibilities include translating insight into strategy and ensure that all MarCom and Product Management activities contribute to our overall customer experience and meet our industry’s quality expectations.
Apr 2022

ICH E8(R1) General Considerations for Clinical Studies

By |2022-04-25T10:48:42+00:00April 8, 2022|News|Comments Off on ICH E8(R1) General Considerations for Clinical Studies

With the release of the final ICH E8(R1) version this month, sponsors and CROs are encouraged to embrace a Quality by Design culture. This final paper is part of a more general Good Clinical Practice (GCP) “Renovation” that involves the modernization of ICH E8 and subsequent renovation of ICH E6.

Mar 2022

Release Notes | MyRBQM® Portal Version 6.8.2

By |2022-03-17T06:54:54+00:00March 17, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.2

MyRBQM Portal V6.8.2 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Jan 2022

Release Notes | MyRBQM® Portal Version 6.8.1

By |2022-01-26T18:21:38+00:00January 26, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.1

MyRBQM Portal V6.8.1 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Oct 2021

Milestone | We Have Just Received our ISO 9001:2015 Certificate

By |2021-11-02T06:29:03+00:00October 26, 2021|Blog, News|Comments Off on Milestone | We Have Just Received our ISO 9001:2015 Certificate

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.

Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2021-12-22T16:59:18+00:00September 30, 2021|Blog, Case Studies|Comments Off on Risks of IMP Management Under Standard vs. Pandemic Conditions

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

Release Notes | MyRBQM® Portal Version 6.7

By |2021-12-22T17:23:16+00:00September 22, 2021|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.7

MyRBQM Portal V6.7 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Aug 2021

Release Notes | MyRBQM® Portal Version 6.3.3

By |2021-12-22T17:22:33+00:00August 2, 2021|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.3.3

MyRBQM Portal V6.3.3 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Jul 2021

Release Notes | MyRBQM® Portal Version 6.3.2

By |2021-07-13T12:44:08+00:00July 6, 2021|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.3.2

MyRBQM Portal V6.3.2 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

May 2021

7 Most Important QTLs for Clinical Trials

By |2021-10-26T09:01:42+00:00May 5, 2021|Blog|Comments Off on 7 Most Important QTLs for Clinical Trials

Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.

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