
|Articles|June 16, 2015
CluePoints Introduces RBM Software for Operational Data Analysis
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach.
Advertisement
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach. The new software includes Key Risk Indicators (KRIs) that complement the statistical analysis of clinical data. This KRI+ approach allows sponsors and CROs to set their own subjective threshold levels, while also statistically examining data objectively to show how a single site's KRIs can be judged against results across all other sites.
Advertisement
Related to this article

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

In this Q&A, Sylviane de Viron of CluePoints and Abigail Dirks, MS, of Tufts CSDD discuss the findings of a collaborative study quantifying the financial value of RBQM, why time savings emerged as the largest driver, and what sponsors struggling to justify adoption now have that they didn't before.

Sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail, requiring sponsors to document oversight as a connected operating system with clear decision records, escalation pathways, and issue resolution from start to finish.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Real-Time Data, Right-Time Decisions: Rethinking Analysis Frequency in RBQM
2
AI and Patient Recruitment: Can Predictive Promise Drive True Transformation?
3
FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review
4
What It Takes to Harmonize AI Across Fragmented Oncology Health Systems
5
