10 Considerations For Small Biotechs Looking To Implement RBQM
AUTHORS: SOPHIE HENDERSON, CUSTOMER SUCCESS DIRECTOR & NICK BORDERS, SENIOR DIRECTOR OF BUSINESS DEVELOPMENT Today, many clinical trial organizations realize the great benefits of Risk-Based Quality Management (RBQM). However, some are still facing challenges in identifying an approach to best implement RBQM in their overall clinical trial strategy. There is a lot to think about, […]
Understanding Trends In QTL Adoption
AUTHOR: SYLVIANE DE VIRON, MANAGER, DATA & KNOWLEDGE, CLUEPOINTS The CluePoints’ Quality Tolerance Limits (QTL) module offers Sponsors and CROs a convenient way to rapidly identify systemic issues and document the approach and any important deviations from the pre-defined QTLs that may be critical to study quality (e.g., impact on safety or reliability of study […]
UK’s MHRA Cites CluePoints Centralized Statistical Monitoring In Updated GCP Guidance
AUTHOR: PATRICK HUGHES, CO-FOUNDER & CHIEF COMMERCIAL OFFICER, CLUEPOINTS We all know that Centralized Statistical Monitoring (CSM) can vastly improve data quality and integrity in a timely manner, boost safety, and slash development timelines. Yet while the benefits of the model have been widely documented, there has, to date, been a lack of information on […]
Risk-Based Fraud Detection: How Centralized Monitoring Can Boost Data Quality
AUTHORS: SYLVIANE DE VIRON, LAURA TROTTA, SEBASTIAAN HÖPPNER, STEVE YOUNG, MARC BUYSE A new study has shown how risk-based monitoring can help detect site fraud at clinical trial sites, protect data quality, avoid delays to market, and keep people safe. We worked with industry and bioinformatics partners to reanalyze the database of a large randomized […]
Software Engineering Skills For A Big Societal Impact
Challenge, opportunity, fun, and the chance to make a difference – CluePoints has everything a talented software engineer is looking for. That’s according to Philippe Thiran, who became the clinical trial technology company’s Engineering Manager just four months ago. As part of a series of blogs by our subject matter experts, he tells us why […]
CluePoints’ Launch Post-COVID Trial Assurance Solution
King of Prussia, PA: CluePoints, the premier provider of Risk-Based Quality Management Solutions for clinical trials, has launched a new Post-COVID Trial Assurance Solution as part of its mission to build safer, more efficient trials for patients, sponsors and, CROs. The pandemic has been the catalyst for many sponsors and CROs to reassess pre-existing monitoring […]
Using Risk-Based Monitoring To Focus On What Matters
Rich Davies, VP Solutions Expert at CluePoints, and Tanya du Plessis, VP Data Solutions and Strategies at Bioforum, explain how to apply the principles of RBQM to Data Management and the benefits of a risk-based approach. Increased Pressures in Clinical Data Management RBQM plays an important part in the way clinical trials are run today. […]
Practical Steps For Centralized Monitoring Success
The successful implementation of Centralized Monitoring requires meticulous planning, process reform and alignment, cross-functional expertise, and most importantly the right technology in place. With regulators advocating greater reliance on Centralized Monitoring practices for effective study oversight, the right understanding and implementation of a Centralized Monitoring approach is essential for maximizing the benefits it can bring. In our […]
The Evolution Of CluePoints’ SMART Engine
How C++ Revolutionized the Core of CluePoints With software playing an integral part of almost every device that makes daily life easier, the same is true for clinical trials. The pharmaceutical and drug development industry relies on intelligent software to make the most of technology, making clinical trials better, faster and cheaper for sponsors and […]
Life As A Clinical Data Analyst At CluePoints
Life as a clinical data analyst at CluePoints is anything but dull – so when I was asked to talk about a typical day, it was something of a challenge. My primary responsibility is the implementation of data surveillance and risk management projects within the CluePoints Central Monitoring Platform for our clinical research clients. But […]
