Change as a Risk?
As change can be a significant source of risk, RBQM or risk-based monitoring (RBM) implementation programs should include a roadmap and change management plan for initiating a process of continuous improvement.
Feb 2020
Dec 2019
Quality by Design | ICH E8(R1) General Considerations for Clinical Studies
ICH E8(R1) discourages the old-school “one size fits all” approach, instead the modern day guidance encourages bio-pharma to go beyond the traditional checklists. We've visualized the 2019 guidance "General Considerations for Clinical Studies". Download our free infographic today to be ready for tomorrow.
May 2019
Centralized Monitoring: a Greater Advantage to a Broader Range of Trials
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Mar 2019
Your Practical Guide to Understanding Clinical KRIs
Our key risk indicator infographic will give you a foundational understanding of KRIs, provide valuable examples of KRIs, and guide you towards getting started with your risk-based monitoring (RBM) program.
Jan 2019
Quality Tolerance Limits versus Key Risk Indicators, The Difference
To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.
Feb 2018
What is the Cost of Poor Quality in Pharma?
Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.
Jul 2016
FDA RBM Guidance MindMap
Which elements must a Risk-based Monitoring (RBM) plan must contain? What are the sponsor responsibilities regarding clinical monitoring? What kind of monitoring methods does the FDA suggest? To answer these questions, please, explore the MindMap of the "Guidance for Industry. Oversight of clinical Investigations - A [...]
Sep 2015
ICH GCP Addendum Mind Map
The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP. Let [...]
Jun 2015
German CROs Structure (Infographic)
Germany is a strong player in outsourcing of clinical trials. Well known CROs as PAREXEL, PPD, ICON or PRA Health have whether subsidiaries or headquarters in Germany. There are about 140 Contract Research Organizations (CROs) in Germany and each of them has its own [...]