Get actionable insights you can trust
Blinded Data Analytics
Optimize clinical endpoint data
Improve assessment quality
Proactively review clinician assessment audio/visual recordings and monitor ongoing rater accuracy and consistency
Eliminate rater inconsistency
Use our data scientists and proprietary algorithms to identify changes in data consistency and reliability, as well as ensure timely corrective actions limit data quality impact
Why choose Signant SmartSignals?
Blinded Data Analytics addresses investigators’ and sponsors’ primary level concerns:
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 outliers and take necessary corrective & preventative action
Data & clinical science converge
Our algorithms examine study data at all relevant levels (rater, site, country, region, and study) to identify trends, anomalies, or statistically significant discrepancies. In collaboration with your study team, we review outliers for potential quality concerns that could adversely affect the accuracy of the data captured and recommend corrective and preventative actions. Data can then be used to anticipate future risks as well as rank sites’ performance, ensuring they are ready to support your next study.
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 Blinded Data Analytics (BDA) 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. Blinded Data Analytics (BDA) 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 Blinded Data Analytics (BDA) be performed on any data?
Yes, although Blinded Data Analytics (BDA) is usually focused on eCOA data supporting the primary endpoint, any data source which could add value to the analysis can be included.
Want to learn more?
Add data analytics to your study to get visibility and insights – contact our clinical data team today