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 […]
ICH E6 (R2) – Miracle Pill For The Clinical R&D Industry
ACRP Clinical Researcher ICH E6 R2 – Miracle Pill for the Clinical R&D Industry Steve Young, Chief Operations Officer, CluePoints Looking for the most up-to-date perspective on ICH GCP? Explore our deep dive into the latest ICH E6(R3) Guidance and what it means for modern RBQM practices, including key changes, timelines, and practical implications for […]
ICH E6 Rev 2 – Ask The Experts
Last week, we hosted our second webinar of 2017, Implementing Risk-Based Monitoring – What Does the ICH E6 Rev 2 Mean for My Company? There were many great questions from the attendees. In fact, we had so many questions that we couldn’t get through them all! So as promised, we’ve documented the most common questions, along with […]
Webinar Recording: What Does ICH E6 R2 Mean For Me And My Company?
This week, CluePoints hosted a webinar with Paragon Solutions, which was geared towards preparing attendees on how to take advantage of the ICH E6 revisions to ensure appropriate consideration of risk in study design and management. Attendees learned about the key ICH E6 updates related to Risk-Based Monitoring and their purpose, how Central Statistical Monitoring and Key […]
6th Annual CROWN Congress: Sessions You Can’t Afford To Miss + 15% Discount Code
It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda for the 6thAnnual CROWN Congress, it’s jam-packed with sessions focused on the eagerly anticipated ICH E6 revisions, the new EU 536/2014 clinical trial regulations, risk management and centralized monitoring.  Of […]
Six Ways To Get The Most Out Of Outsourcing In Clinical Trials West Coast ‘17
There’s only a couple of weeks to go until Arena’s flagship event, Outsourcing in Clinical Trials West Coast returns to Burlingame. The must-attend event brings together over 700 clinical professionals from the Bay Area and beyond, to discuss clinical outsourcing strategies and overcome key challenges within clinical operations. From sessions to booth activities to after-hours […]
