Complimentary COVID-19 Risk Assessment Package Available To All At No Cost
COVID-19 Risk Planning As advised in the coronavirus guidances recently issued by FDA, EMA, and MHRA, it is important to perform a fresh risk assessment for each study to identify and mitigate risks pertinent to the COVID-19 crisis. Your organization is likely already aware of key challenges that will be common to most if not […]
Implementing A Risk-Based Quality Management Strategy – The Ultimate Guide
Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization has specific influencing factors such as therapeutic areas, existing processes, and various technologies. Our latest guide, produced by our Chief Scientific Officer, Steve Young, takes a look at considerations for ensuring not […]
Transitioning From A Risk-Based Monitoring Approach To Risk-Based Quality Management
This content was originally posted on Applied Clinical Trials on March 18, 2019 One of the most significant positive changes we have seen recently is the endorsement of ICH E6 (R2) which insists that Sponsors and CROs adopt a risk-based approach to study execution. This paradigm shift in the industry ensures that Sponsors undertake risk assessment during […]
Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!
When the journey started it was all about monitoring. It was about addressing the inefficiencies, rationalizing resources to reduce costs and tackle potential quality issues that could put the clinical trial at risk. “Focus on what really matters” was born, Risk-Based Monitoring was alive. As more people embark on the journey, it’s becoming less difficult to convince […]
ICH E6 R2 – The Clinical R&D Industry’s Response
For decades now the complexity, cost, and duration of clinical development have been steadily increasing while profit margins for the industry have been dwindling. This crisis persists and is compounded by inefficient traditional methods of managing clinical trial quality. The ICH Good Clinical Practice Guidance Integrated Addendum (ICH E6 R2) provides a unified standard for […]
Beyond Risk-Based Monitoring: How Intelligent Analytics Are Being Used To Drive Value And Support ICH Compliance
The complexity and size of clinical trials has increased dramatically – in parallel with growing costs and mounting regulatory pressures. The introduction of the finalized International Council for Harmonization’s (ICH) addendum to the ICH E6 Guideline for Good Clinical Practice (ICH E6 R2) earlier this year means that organizations across the industry are currently reviewing the update […]
The Bigger Picture Of ICH E6 R2: Looking Beyond Compliance
Journal for Clinical Studies Steve Young, Chief Operations Officer, CluePoints The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based monitoring principles a matter of GCP compliance. While clinical research organizations across the industry are now finally compelled to study the new guidance in order to roll out a compliant RBM strategy, […]
ICH E6 R2: Talking Big Pharma’s Response To The Addendum
This article was originally produced for Clinical Informatics News The introduction and implementation of ICH E6 R2 has raised many questions surrounding operational risk-based approaches to clinical trial oversight. With the industry now in the process of getting to grips with more modernized practices for study conduct mandated by the guidance, this article addresses how sponsors are working […]
ICH E6 R2 Roundtable Review – What Does This Mean For The Industry?
The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry. In response, and to better understand the perception of the new guidance by Pharmaceutical companies, Tufts, CluePoints and PWC organized a roundtable, which included senior executives from top tier pharmaceutical organizations that […]
ICH E6 R2: Waiting And Watching No Longer An Option When It Comes To Risk-Based Monitoring
As is typical of our industry, despite ringing endorsements of Risk-Based Monitoring (RBM) from both the FDA and EMA back in 2013, researchers have been conservative with respect to adopting this proven approach as standard within their clinical trials. However, the introduction of ICH E6 R2 this year means that waiting and watching is no […]
