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.
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.
13 March 2017
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has introduced Patient Profiles to its rapidly expanding platform. The powerful combination of Patient Profile reports, guided by CluePoints’ advanced central statistical monitoring, offers a new way for clinical teams to prioritize the investigation of atypical patients in clinical trials.…
The Central Monitoring Workgroup will feature speakers from several solution providers who will each present and discuss the types of analytic methods that are relevant for centralized monitoring and data quality oversight. The first speaker will be Steve Young, COO at CluePoints (and the Metrics Champion Consortium’s Central Monitoring Workgroup leader), who will talk about Statistical Probability Analysis including the specific types of operational issues that it can uncover.
We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform for Risk-Based Monitoring, will be available to users in April! Version 1.11.0 adds an abundance of new features (as requested by customers) and extensions to existing functionality.
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 6th Annual 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.
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.
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced that it has won a Clinical Informatics News Best Practices Award for “creating the ultimate Risk-Based Monitoring and Data Quality Oversight Solution.” The Clinical Informatics News Best Practices awards recognize outstanding examples of applied strategic innovation-partnerships, deployments, and collaborations that manifestly improve the clinical trial process.
Are you ready for an FDA site inspection?
You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development Agreement(CRADA) explores a data-driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.