Jul 2021

How to Build Critical to Quality Trees for Clinical Research

By |2021-08-02T10:19:22+00:00July 29, 2021|Blog|0 Comments

Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.

Jun 2021

Adverse Event Reporting as an Example of the Risk Assessment Process

By |2021-08-02T15:33:48+00:00June 29, 2021|Blog|0 Comments

Do you find the prospect of Risk Analysis and Risk-Based Quality Management (RBQM) to be daunting? Then bear with us. We shall help you simplify and demystify the process by using an example to illustrate the key steps to consider.

Nov 2020

Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

By |2021-03-16T14:12:24+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Controlling the Number of Open Queries

By |2020-11-03T14:43:21+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Accurately Predicting Important Events

By |2020-11-03T14:44:18+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Nov 2020

Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest

By |2020-11-03T14:45:36+00:00November 3, 2020|Blog, Case Studies|0 Comments

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

Apr 2019

FDA Q&A Draft Guidance Document: The RBM Process-Technology Fit

By |2019-05-27T15:16:11+00:00April 15, 2019|Blog|0 Comments

Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.

Mar 2019

15. DVMD-Fachtagung in Düsseldorf

By |2019-03-04T07:31:03+00:00March 5, 2019||Comments Off on 15. DVMD-Fachtagung in Düsseldorf

Die Fachtagungen des DVMD sind jedes Mal ein informativer Querschnitt aus allen relevanten Themen rund um Dokumentation und Informationsmanagement in der Medizin. Jede Fachtagung greift dabei immer ein Schwerpunktthema auf. In 2019 wird es der Einfluss der Digitalisierung auf die Medizin sein.

Oct 2018

Data Integration – A Valid Concern or a Convenient Excuse?

By |2020-09-23T10:10:46+00:00October 11, 2018|Blog|0 Comments

Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.

Upcoming Events

  1. CORE West by Halloran

    September 22 - September 24
  2. 25. Jahrestagung der GQMA

    September 23 - September 24

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