MedAvante-ProPhase clinicians apply our expertise with measurement science and signal detection to address the root causes of failed trials. We provide services that mitigate the risks of bias, variability and human error. Our Virgil Platform enables the seamless, integrated delivery of each service.
Independent Ratings
Our network of expert clinicians remotely administers and scores assessments to minimize bias and variability.
Independent Review
Our clinicians over-read selected assessments to improve quality of administration and scoring.
Rater Qualification and Certification
Our training minimizes variability across groups of raters and prepares clinicians effectively and efficiently for a study.
Clinical Data Analytics
Our statistical and data experts work with our clinical scientists to open unique windows into a study’s progress.
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.
- Minimizing scoring variability enhances study power.
- Increased study power allows for smaller sample sizes.
- Up to 66% fewer raters are required to complete the same number of assessments as traditional site-based raters.
- Independent Ratings helps sponsors access subjects at sites without professionals in their therapeutic area.
Request info
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.
- Independent Reviews are performed by the industry’s only cohort of clinicians trained to the same standard.
- The Virgil platform facilitates the entire process – no extra steps are required.
Request info
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:
- Initial qualification of raters
- Scale-specific didactic and applied learning delivered online or face-to-face
- Rater certification on key instruments (e.g., primary endpoint measures) based on demonstrated scoring and/or administration proficiency
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.
Request info
Clinical Data Analytics
Open unique windows into a study’s progress
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.
Request info