Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints Central Monitoring platform. From out-of-the-box integration for data sources to more in-depth Patient Profiles reporting, our latest version is sure to delight. This new release demonstrates our ongoing commitment to continuously evolve our platform and add in features requested by our vast user base.
This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking place on September 14-15. If you haven’t decided if you’re attending or not, we’re sure that our eight reasons to attend Global Risk-Based Monitoring will help you with that decision.
Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s edition, taking place on September 6-7, 2017, at The Westin Waterfront, Boston, will gather an unprecedented number of industry experts set on equipping you with the tools necessary to optimize your clinical outsourcing strategies and in-house processes.…
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 have responsibility for facilitating the changes required by the new guidance.
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 longer acceptable.…
2 May 2017
Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, today announced that it will be expanding its operations in the U.S. with the opening of a new office in Wayne, PA.…
The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26, 2017 to April 27, 2017, brings together leading authorities from FDA, industry, and academia to address statistical topics through two tracks – therapeutic device and diagnostics.
ACRP Clinical Researcher
ICH E6 R2 – Miracle Pill for the Clinical R&D Industry
Steve Young, Chief Operations Officer, CluePoints
Publication of the long-awaited ICH E6 (R2) Guideline this year finally makes it official. A risk-based approach to clinical trial quality management – commonly referred to as risk-based monitoring or RBM – is now a codified GCP expectation for the industry.
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!…
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 Risk Indicators will work for them, and how to use the E6 R2 to support their organization’s transition to Risk-Based Monitoring.