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.
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.
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
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.
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.
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.
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 [...]
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 [...]
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 [...]
