Meet SPOT: Transforming Site Monitoring Practices with Adaptive Intelligence
Site monitoring is one of the most expensive components of clinical trials; on-site monitoring alone accounts for around 25 to 30% of the total trial expenses.1 A substantial portion of the clinical trial timeline involves inefficient Source Data Verification (SDV) and Source Data Review (SDR) activities, which can also consume a significant part of a […]
A New Era of Automation: Improving Efficiency & Outcomes with Intelligent Medical Coding
In clinical trials, patient data such as adverse events and concomitant medications is coded against standard medical dictionaries. However, this process comes with challenges. A large number of codes require manual review and duplicate work, making the task labor-intensive and highly inefficient. These manual efforts can lead to inconsistencies in coded terms across coders and […]
Centralized Monitoring in Clinical Trials: Everything You Should Know
What Is Centralized Monitoring? Centralized monitoring is a key component of Risk-Based Quality Management (RBQM) that enables proactive detection of quality-related risks, both pre-identified and unanticipated, during clinical trials. Central Statistical Monitoring (CSM) is a subset of central monitoring that specifically uses advanced statistical and analytical methods to identify unusual patterns in the trial data. […]
Centralized Monitoring In Clinical Trials: Everything You Should Know
What Is Centralized Monitoring? Centralized monitoring is a component of risk-based quality management (RBQM) that aims to detect emerging quality-related risks (either pre-identified or unanticipated risks) proactively during the conduct of a clinical trial. There are three main elements of centralized monitoring: Statistical Data Monitoring (SDM) serves as an unsupervised method for quality oversight in […]
What Is Trending In Data Management And AI?
With the advent of AI promising to transform the way we process and interpret data, there has never been a more exciting time to be working in clinical data management. The buzz around technologies like machine and deep learning (ML/DL) has been palpable throughout 2023, and was particularly at hot topic at this year’s Society […]
A Year In Review: 2023 As A Watershed Moment In The Evolution Of Clinical Data Management
From risk-based quality management’s (RBQM) inclusion in ICH E6 (R3) to the roll-out of numerous AI-driven solutions, 2023 has been a year of huge advance for clinical data management – and could mark a tipping point in the adoption of Research 2.0. Here, Andy Cooper, CEO at CluePoints highlights the milestones and breakthroughs of the […]
How To Leverage Machine Learning & Deep Learning For Natural Language Processing In Clinical Trials
Machine learning (ML) and deep learning (DL) are transforming natural language processing (NLP). A key use case is medical coding. ML models can significantly reduce the manual effort needed for this process, making the use of auto-coding tools more lightweight. They can also streamline dictionary updates and final coding reviews through direct coding and automatic […]
Enhancing RBQM With Artificial Intelligence: Your Questions Answered
Traditional clinical trial data management is often manual, cumbersome, and vulnerable to human error, slowing progress and compromising quality. Streamlining these processes isn’t just a nice-to-have; it’s a game-changer. Risk-Based Quality Management (RBQM) has already raised the bar by accelerating studies and enhancing oversight. But there’s even greater potential on the horizon: artificial intelligence (AI). […]
Transforming Clinical Trials with AI: Smarter, Faster, Higher Quality
The average Phase III study generates a staggering 3.4 million data points . That’s more data than a human team could process manually in a lifetime. And while data collection has become easier, extracting meaningful, actionable insights is often the most challenging part. Fortunately, the advent of artificial intelligence (AI) has presented researchers with a […]
International Women’s Day: Laura Trotta
Author: Laura Trotta ‘Bring technology to the healthcare industry and impact people’s lives.’ In a new series of blogs to mark International Women’s Day, VPs from across CluePoints share their experiences, challenges, and advice for anyone wanting to pursue success. Laura Trotta, VP of Research, talks about why you should continuously pursue what interests you […]