|
Working With MedAvante
Sponsors can use MedAvante's centralized clinical experts in ways to profoundly increase their study’s power and reduce variability
The fundamental benefits of the MedAvante solution stem from its centralized structure. Centralizing expert raters and managing them in real time makes it technically feasible to continuously train, monitor and calibrate the entire cohort. MedAvante expert raters are highly skilled in the art and science of administering diagnostic and symptom-severity assessment scales using structured interview guides and standardized, proprietary conventions to be used for scoring individual items. 
MedAvante’s platform addresses issues of biases and variability of results by providing the services of this expert, rigorously trained and continuously calibrated cohort of clinical raters via high quality telecommunications (audio and video). Our platform connects MedAvante expert raters to any investigative site to administer the clinical study instruments, screening and symptom-severity assessments. MedAvante's remote raters are ‘blinded’ to site, patient history and visit order to overcome biases.
Centralized rating, using our expert cohort allows: - Highest ICCs and inter-rater reliability in the industry
- Increased effect size, study power and/or reduced sample size required
- Access to subjects at investigative sites without CNS professionals
- Real-time study metrics of enrollment diagnostics, inter-rater reliability & interview quality
- Patient Ascertainment screening
Centralized monitoring of site-administered study assessments: The geographically and independently managed site investigators are trained, monitored, evaluated and calibrated to the MedAvante expert trainers. Continuous Quality Control (CQC) monitoring service offers many benefits. - Study assessments are recorded (audio or video) and then reviewed by MedAvante’s centralized expert trainer cohort
- Tightly calibrates the cohort of site raters to the centralized cohort of MedAvante expert trainers
- Alerts sponsor to discordance on assessments with Central Trainer - particularly important on enrollment decisions
- Real-time study metrics of enrollment distributions, rater reliability & interview quality
- Observation minimizes rater drift and ratings variability
- Use Continuous Quality Control (CQC) just for Patient Ascertainment or for reviewing all study assessments
If the trainers are not rigorously calibrated themselves they will introduce noise into the study.
|