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PureSignal Analytics
Clear signals, clean data, clinical confidence.
Combining clinical expertise with advanced analytics, PureSignal Analytics proactively addresses COA endpoint data quality and reliability risks before they impact a study’s ability to distinguish treatment intervention effects.
Safeguard clinical endpoint data
Improve assessment quality
Eliminate rater inconsistencies and administration or scoring errors through proactive review of endpoint data quality throughout study conduct.
Optimize site performance
Leverage protocol-specific algorithms and in-house clinicians to detect site-level issues and implement timely corrective actions to ensure endpoint data quality.
Why choose PureSignal Analytics?
PureSignal Analytics is our leading blinded data analytics solution.
Mitigate COA data risks that can impact signal detection.
Verify that sites are adhering to protocol requirements
Prevent inappropriate participants from being randomized into your trial
Validate that raters administer scales consistently and correctly
Identify data quality concerns and take necessary corrective & preventative action
Converging clinical science & analytics
Our algorithms examine COA data issues at all relevant levels (rater, site, country, region, and study) to uncover trends, anomalies, or statistically significant discrepancies. Working in close partnership with your study team, our clinical experts translate these insights into proactive and targeted interventions that drive data quality and reliability, and protect signal detection. Our solution empowers sponsors with data-driven decision support while providing performance analytics to optimize site and rater selection for future trials.
Need Proof?
Explore case studies to learn how PureSignal Anaytics prevents flawed data from compromising study data quality.
FAQs
What is the purpose of blinding in clinical trials?
Blinding in clinical trials is an important methodology to minimize bias and maximize the validity of the results
How is PureSignal Analytics different from Risk-Based Monitoring in clinical trials?
While centralized clinical trial statistical analysis of endpoint data employed by blinded data analytics can be used as a marker for site or rater quality and can be incorporated into broader risk-based monitoring methodologies, it is neither a competitor to or a replacement of a sponsors’ or CRO’s risk-based management strategy. PureSignal Analytics is complementary to Risk-Based Management (RBM), focusing entirely on clinical endpoint data quality, while the remainder of RBM focuses on the other components of site quality (i.e., number of protocol deviations, unreported AEs, etc.).
Can PureSignal Analytics be performed on any data?
Yes, although PureSignal Analytics is primarily focused on eCOA data supporting the primary endpoint, any data source which could add value to the analysis can be included.