SmartSignals eCOA

Electronic Clinician Ratings

A way to improve data quality and reliable clinician-rated endpoint data 

Manage endpoint measure risk factors

  • Reduce scale administration errors
    Pre-set workflows, on-screen guidance, and automated scoring validation ensure that scales are administered and scored correctly 
  • Optimize subjective clinician assessments
    Reduce inter- and intra- rater reliability with rater reviews, and capture audio/video of interviews for expert central ratings 
  • Improve data reliability
    Prevent missing or incomplete data and transcription errorsbuild regulatory-compliant audit trails 

 

Electronic vs paper

Clinician-reported outcomes (ClinROs) that use paper make studies susceptible to human error and missing data. Leveraging eCOA technology with ClinROs improves data quality. Unlike paper and form-based eCOA, electronic clinician ratings proactively detects scoring and administrative errors prior to submission.

Signant Health’s electronic clinician ratings reduce scoring and administrative errors by up to 80% compared to paper and form-based eCOA.

Why choose SmartSignals?

  • Customizable, proprietary monitoring solutions offer the industry’s most robust electronic clinician ratings capabilities.
  • Evidence-based algorithms, descriptive, and inferential statics, as well as predictive analytics identify potential data anomalies in near real-time.
  • Protocol and scale consultations help you navigate electronic clinician ratings complexities, such as obtaining licenses and validating translations.
  • Internal clinicals and a global network of independent central reviews and raters are trained, certified, and regularly calibrated.

Together, we’ll help ensure your enrolled participants meet eligibility requirements and raters conduct data quality reviews throughout your entire study.

Our Electronic Clinician Ratings feature:

  • Automated scoring validation when applicable
  • On-screen guidance and alerts, helping raters to correctly administer scales  
  • Periodic rater reviews for quality control  
  • Analytics highlighting outlying data patterns color-coded graphs and intuitive charts 
  • Integrated and secure audio/video capture of interviews that can be reviewed by independent expert clinicians 
  • An audit trail that captures data modifications made prior to submission  
  • Flexible and customizable edit checks and notifications  

Frequently Asked Questions

What is endpoint in clinical research?

Clinical endpoints are measurable outcomes used to address the objectives of a clinical trial, such as survival, decreased pain, or the absence of disease.

What is a primary endpoint in clinical trial?

Primary endpoints measure outcomes that will answer the most important question being asked by a trial, such as whether a new treatment is better at preventing disease-related death than the standard therapy. Secondary endpoints answer other relevant questions about the same study, such as outcomes rated by patients such as quality of life.

How do you ensure data quality in clinical research?

Innovative technology, routine training, and guidance from experienced subject matter experts help researchers ensure high data quality. Signant offers all of those solutions and services, catering to the unique needs of sponsors and regulators.

Want to learn more?

Add Electronic Clinician Ratings to your study to collect reliable clinician-rated endpoint data – contact our team today.