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SmartSignals Analytics

Blinded Data Analytics

Get actionable insights that you can trust

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 SmartSignals?

Blinded Data Analytics addresses investigators’ and sponsors’ primary level concerns: 

1

Verify that sites are adhering to protocol requirements

2

Prevent inappropriate participants from being randomized into your trial

3

Validate that raters administer scales consistently and correctly

4

Identify outliers and apply corrective and preventative measures as necessary

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.  

Frequently Asked Questions

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.