PureSignal Analytics

PureSignal Analytics, from Signant Health, is a blinded data analytics solution designed to safeguard clinical endpoint data quality and reliability in clinical trials. By combining advanced algorithms with in-house clinical expertise, it proactively identifies and addresses risks related to Clinical Outcome Assessment (COA) endpoint data before they can compromise a study's ability to detect treatment intervention effects.

PureSignal Analytics is purpose-built for clinical trial sponsors and study teams who need data-driven confidence in their endpoint data. The solution is complementary to existing Risk-Based Monitoring strategies, focusing specifically on clinical endpoint data quality — including eCOA data supporting primary endpoints — across all levels of a study.

Core Capabilities

• Proactively reviews COA endpoint data quality throughout the entire course of study conduct
• Eliminates rater inconsistencies and corrects administration or scoring errors before they impact results
• Leverages protocol-specific algorithms to detect site-level issues and enable timely corrective actions
• Verifies that sites are adhering to protocol requirements
• Prevents inappropriate participants from being randomized into a trial
• Validates that raters administer scales consistently and correctly
• Identifies data quality concerns and supports corrective and preventative action

Analytics Approach: Converging Clinical Science and Data

• Algorithms examine COA data issues at all relevant levels, including rater, site, country, region, and study
• Uncovers trends, anomalies, and statistically significant discrepancies across these levels
• In-house clinical experts translate analytical insights into proactive, targeted interventions
• Works in close partnership with sponsor study teams to drive data quality and protect signal detection
• Provides performance analytics to support data-driven decision-making for sponsors
• Delivers insights that can optimize site and rater selection for future trials

Therapeutic Areas and Use Cases

• Improving PANSS assessment quality in Phase III schizophrenia trials
• Enhancing Phase III trial quality through analytics and central review
• Ensuring entry criteria compliance in psychiatry trials
• Preventing trial data fraud in global studies through real-time analytics
• Guiding critical go/no-go decisions in neurology trials
• Optimizing psychiatric trial recruitment strategy through smart analytics

Key Differentiators

• Operates as a blinded data analytics solution, preserving trial integrity while enabling proactive quality oversight
• Complements rather than replaces Risk-Based Management strategies, focusing exclusively on clinical endpoint data quality
• Can incorporate any data source — not limited to eCOA — that adds analytical value to the study
• Empowers sponsors with evidence-based decision support across therapeutic areas

PureSignal Analytics is applicable across a broad range of clinical trial contexts and therapeutic areas, and can be integrated into a study's existing data management and risk-based monitoring framework. Sponsors and CROs seeking to improve signal detection, ensure rater and site compliance, and make confident, evidence-based decisions can engage Signant Health's clinical data team to discuss protocol-specific applications.