Independent Ratings is a comprehensive, customized solution that protects sponsors against bias and variability – root causes of inconclusive trial results.
We are the world leader in Independent Ratings, having pioneered the methodology over a decade ago. In that time, we have completed more than 60 Independent Ratings studies, and our expert Independent Raters have achieved the highest inter-rater reliability in the industry.
Uniting proven clinical value with logistical expertise, MedAvante-ProPhase Independent Ratings streamlines the complex process of coordinating global trials.
How does it work?
MedAvante-ProPhase Independent Raters remotely conduct live clinical assessments of subjects at study sites, either by telephone or videoconference. Independent Raters are trained to a single standard, monitored and calibrated with one another to minimize variability.
Because they are remote, Independent Raters are less subject to biases that may dampen signal detection. They are “blinded” to protocol details and subject history, and are uninfluenced by repeated contact with subjects.
Independent Ratings increases study power and reduces sample sizes.
Independent Review is a rigorous monitoring service in which MedAvante-ProPhase clinicians review selected assessments that were administered by site raters. This post-hoc analysis facilitates real-time data review and helps keep your study on track. Our expert clinician raters are trained to meet an exacting standard of uniformity, and we provide stringent guidelines for conducting Independent Reviews.
Independent Review helps sponsors improve the quality of data collected throughout the study from screening to baseline and endpoint.
How does it work?
Highly qualified, experienced clinicians (fluent in the local language of each study country) review recordings, notes and source documents. Our global team maintains calibration and quality control through intensive training and ongoing reliability measurements.
Assessments are selected for review by a criteria-based algorithm, and any issues are swiftly identified and communicated to the sponsor.
MedAvante-ProPhase delivers highly flexible training based on years of clinical expertise and extensive trial experience, firmly grounded in proven concepts of adult learning.
The MedAvante-ProPhase training team includes clinical and psychometric experts, as well as authors of widely used rating scale instruments. We have trained thousands of raters for trials around the world in a variety of therapeutic areas.
Our training programs are tailored to study needs and include:
The multi-language MedAvante-ProPhase eLearning Center is online 24/7 and fully compliant with CFR part 21, allowing continuous opportunities for additional self-training or refreshers – which are especially useful during long studies with high turnover.
Data analytics is a powerful tool for improving the conduct of a clinical trial.
MedAvante-ProPhase statisticians and clinical scientists collaborate closely to help sponsors understand from a quality perspective how clinical data are progressing throughout the study.
We can take data from the Virgil platform and virtually any other source to pair with risk-based algorithms to develop and visualize specific data quality metrics at the study-, site- or rater-level.
For example, we can build algorithms to analyze data within rating scales, between scales at the same visit, cross-visit relationships, protocol-specific risks or potential adverse events.
Our focus is on corroborating key data elements with statistical interpretation while they are being collected and there is still time to catch potential problems.