What Does Risk Mean?
July 2019, Clinical Informatics News
CluePoints Launches Risk-Based Monitoring Roadshow in Tokyo – CenterWatch
November 6, 2017
CluePoints, a provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase work in Japan by entering into two new partnerships with global top 20 pharmaceutical companies…
ICH E6 R2 Roundtable Review – Applied Clinical Trials
August 7, 2017
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…
CluePoints’ Central Statistical Monitoring Software Adds Integrity to Clinical Trials – Clinical Informatics News
March 30, 2017
If you asked the staff at CluePoints about the state of risk-based monitoring (RBM), they would probably tell you that the current process is antiquated at best. In fact, according to CluePoints, clinical site monitoring has almost exclusively been carried out through onsite visits done routinely every four to eight weeks…
CluePoints Launches Ground-Breaking Data Quality Oversight Service – News Medical Life Sciences
November 2, 2016
CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced a new Data Quality Oversight service, RADARTM, aimed at helping sponsors achieve a data-driven understanding of risks to an inspection-ready level.
CluePoints Introduces Data Quality Oversight Service for Site inspection Readiness – Pharmiweb
October 31, 2016
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced a new Data Quality Oversight service
FDA Inks Deal with CluePoints to use Data to Sniff out Sloppy or Fraudulent Clinical Trials – Mass Device
October 12, 2016
The federal safety watchdog said the agreement calls for CluePoints to mine the data for signs of anomalies indicative of “fraud, misconduct or sloppiness.” The groups will develop and test improvements to CluePoints’ software, aiming to create a list of “anomalous sites” with data that are highly inconsistent with other trial sites.
FDA Signs CRADA with CluePoints – Applied Clinical Trials
October 12, 2016
The FDA has signed a Cooperative Research and Development Agreement (CRADA) with CluePoints for its Central Statistical Monitoring solution to explore a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness.
CluePoints CEO, Francois Torche, Honored in PharmaVoice 100 – PharmaVOICE
August 2, 2016
CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has today announced that its CEO, François Torche, has been selected by PharmaVOICE as one of the top 100 most influential people in the life-sciences industry.
CluePoints Named Clinical Research & Excellence Awards Finalist – PharmaVOICE
March 14, 2016
CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, has been named a finalist in the ‘Best Sponsor-Focused Technological Development’ category for the 2016 Clinical Research & Excellence (CARE) Awards.
CluePoints not ‘clueless’ when it comes to Risk-Based Monitoring Solutions – DDNews
January 20, 2016
Aimed at meeting the latest global regulations for conducting clinical trials, CluePoints, a software provider of risk-based monitoring (RBM), has launched a collaboration with Widler & Schiemann Ltd., working in the area of quality management in clinical trials and drug safety.
CluePoints Introduces Risk-Based Monitoring Software for Operational Data Analysis at DIA 2015
June 16, 2015
CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today introduced software to enable analyses of operational data using a risk-based monitoring approach at DIA 2015. The new software includes Key Risk Indicators (KRIs) that perfectly complement the statistical analysis of clinical data.
Oracle Offers CluePoints Solution for RBM
April 23, 2015
CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced their collaboration with Oracle Health Sciences, combining CluePoints’ award-winning risk-based monitoring (RBM) solution with Oracle’s clinical data capture and management platform, Oracle Health Sciences Inform Cloud Service.
CluePoints, ACRES Partner to Identify Data Quality Risks
March 27, 2015
CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit organization dedicated to building a stakeholder-driven integrated global system for clinical research, today announced a strategic partnership.
Central Statistical Monitoring Case Studies Added to Regulatory Agency Site
November 19, 2014
CluePoints’ SMART™ engine, is a statistical software solution that examines if data collected are consistent, and if not, pinpoints those investigator sites that differ substantially from the others involved in a trial. In this regard, it is powerful in detecting outlying sites, but would be limited in detecting a systematic issue affecting all sites in the trial because no site would be an outlier.
CluePoints Survey Results Reveals that Determining the Best Approach is the Industry’s Biggest Challenge to Implementing a Risk-Based Monitoring Strategy
August 23, 2014
A survey by CluePoints, Partnerships in Clinical Trials sponsors and a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has revealed that 42% of respondents from across the industry consider agreeing the best and most practical approach to be the biggest challenge their organizations are facing in implementing an effective Risk-Based Monitoring (RBM) strategy.
CluePoints Launch New Web Application for Risk-Based Monitoring
August 13, 2014
Partnerships in clinical trials parter CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced a web-based version of its intelligent risk-based monitoring platform that enables sponsors to determine the quality and integrity of their clinical trial data.
GSK Vaccines Complements its RBM Plan with CluePoints
October 11, 2014
Earlier this year, a new intelligent statistical modeling solution was introduced. The product and the company, called CluePoints, come to market with a proven pedigree, with research and development from an academic standpoint for the last few years, culminating in a collaboration with GSK Vaccines before its commercial rollout.
CluePoints’ Statistical Strategies Enhance Risk-Based Monitoring
December 13, 2013
Francois Torche, CEO of CluePoints, a statistical monitoring provider, has a front row vantage point on the ongoing industry-wide shift to risk-based monitoring (RBM). He sees RBM as critical to improving the quality of clinical trial data through the use of statistical methods that help define more effective on-site monitoring strategies.
Software Offers Sponsors, CRO’s Improvements to On-Site Monitoring
October 11, 2013
As on-site monitoring can account for as much as 30% of a late-stage trial’s cost, CluePoints last week launched a new software system to help companies target on-site monitoring of clinical trials by identifying centers with anomalous and inconsistent data.
The Practical Implementation of Risk-Based Monitoring
August 1, 2013
Data quality matters most in determining study success and ensuring patient safety. However, patient numbers continue to rise, CRFs are becoming more complex with each new study and, with the use of sites around the globe, these elements significantly impact the ability to guarantee the quality and integrity of clinical trial data while containing costs.
Software Outfit Tackles Multi-Billion Dollar Bugaboo in Clinical Trials
January 22, 2013
CluePoints, which has offices in Cambridge, MA, and Belgium, says that its patent-pending software called SMART features algorithms that can spot anomalies and site errors in data sets from CROs and pharma sponsors. Its service and reports back to customers are intended to help them identify the source of inaccuracies and aid them in pinpointing which clinics in trials should be closely monitored.
CluePoints Offers New Solutions for Risk-Based Monitoring
January 22, 2013
Regulatory preference for risk-based monitoring of clinical-trial sites is behind the launch of CluePoints, a new US-based software and service provider offering Intelligent Statistical Monitoring solutions.
CluePoints is an offshoot of eClinical and biostatistical services provider International Drug Development Institute (IDDI), which has spent a decade perfecting the statistical algorithms that make up CluePoints’ core SMART platform.
CluePoints Launches Intelligent Solution to Risk-Based Monitoring
January 16, 2013
A new software and service provider of Intelligent Statistical Monitoring solutions – CluePoints – has been launched to allow biopharmaceutical sponsors and CROs to identify signals in a clinical trial data set and make timely decisions about which sites to target for monitoring activities and Source Data Verification (SDV).