Natural Language Processing Improves Risk Signal Documentation In Clinical Trials
Authors: Sylviane de Viron, Data and Knowledge Manager Nicolas Huet, Machine Learning Manager Central monitoring helps sponsors proactively identify quality issues in clinical trials. To meet regulatory requirements, support continuous improvement, and enable further optimization of issue detection through machine learning, it is imperative to document the follow-up of central monitoring findings from initial detection […]
The Best Of Both: The Key Reasons To Outsource RBQM Tech But Keep Data Control
You can outsource the work, but you can’t outsource the responsibility – so should you outsource Risk-Based Quality Management (RBQM)? It’s a question pharma companies are increasingly asking themselves as the industry continues to adopt this new efficient way of working. Here, Rick Ward, Senior Vice President at CluePoints, talks us through the key considerations […]
10 Reasons Why CROs Leverage CluePoints For RBQM
Written by Andrea McSweeney, Vice President of Customer Success – Channel, CluePoints Contract research organizations (CROs) are uniquely positioned to partner with sponsors on risk assessment and monitoring activities—but they must have the systems in place to ensure subject safety and data quality across their study portfolios. CluePoints can offer the tools to aggregate data […]
CluePoints To Share Case Study On Technology ROI At The SCDM 2022 EMEA Leadership Forum & Conference
Decentralized clinical trials (DCTs) have become a buzzphrase in recent years, with commentators lining up to extol the benefits of this new way of working. Practical advice on how to adopt and implement the model, however, has been thinner on the ground. Organizations may still be wary of their return on investment (ROI) when it […]
Join Us At DIA 2022 As We Demystify The De-Risking Of DCTs
The world of decentralized clinical trials (DCTs) and risk-based quality management is evolving rapidly – but CluePoints and our partners are here to help you stay abreast of the latest developments. John Hall, the company’s Senior Vice President for EU and APAC, will lead a session on de-risking DCTs at this year’s Drug Information Association […]
10 Ways The Pandemic Changed CluePoints
AUTHOR: PATRICK HUGHES, CO-FOUNDER & CHIEF COMMERCIAL OFFICER, CLUEPOINTS As CluePoints celebrates ten years as the leading provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management (RBQM) software for clinical trials, co-founder Patrick Hughes looks back on the changes the company has undergone in that time – as well as takes a broader look at the […]
Does Central Monitoring Lead To Higher Quality? An Analysis Of KRI Outcomes
AUTHOR: SYLVIANE DE VIRON, MANAGER, DATA & KNOWLEDGE, CLUEPOINTS AND WILLIAM STEIJN, RESEARCH DATA ANALYST, CLUEPOINTS Central Monitoring is a key component of Risk-Based Quality Management (RBQM). Many organizations have now implemented it to enable and support pro-active quality oversight of clinical research. Central monitoring aims to detect emerging quality issues pro-actively during a clinical […]
10 Ways Mid-Sized BioPharma Has Applied A Pragmatic Approach To RBQM Implementation
AUTHOR: DAN BEAUDRY, SENIOR VICE PRESIDENT, CUSTOMER SUCCESS As the shift towards decentralized clinical trials accelerates, powered by the COVID-19 pandemic as well as the more patient-centric approach it provides, there is a significant role to be played by risk-based quality management (RBQM) technology. Designed to support the remote collection and monitoring of clinical trial […]
RBQM Moves into the Spotlight in FDA’s Updated BIMO Guide
AUTHOR: PATRICK HUGHES, CO-FOUNDER & CHIEF COMMERCIAL OFFICER, CLUEPOINTS It’s official: Risk-Based Quality Management (RBQM) is no longer optional. It’s essential for the smooth running of clinical trials. The latest version of the FDA’s Bioresearch Monitoring Program (BIMO) guide calls for quality management systems to play a more significant role in regulatory inspections. Good Clinical […]
CluePoints Co-Founder And Chief Executive Officer To Speak At SCOPE Europe
Francois Torche, Co-Founder and Chief Executive Officer at CluePoints, will share insights into utilizing Risk-Based Quality Management (RBQM) to improve trial outcomes at this year’s SCOPE Europe, the 4th annual Summit for Clinical Trials Operations Executives. Harnessing Risk-Based Quality Management and Deep Learning to Improve Trial Knowledge and Drive Better Decision-Making and Outcomes will occur at 3:55 […]
