MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries. They pioneered a solution for one of the most intractable problems in Central Nervous System (CNS) clinical trials: the high rate of failed studies. MedAvante applies its unique methodology to systematically remove potential sources of bias and variability from the diagnosis and assessment process. By centralizing assessments with expert raters utilizing real-time, remote video and telephone conferencing, MedAvante makes subjective assessments of subject selection and drug efficacy increasingly objective. As a result, sponsors can achieve increased study power and reduced trial-failure rates, enabling them to bring more effective CNS drugs to market sooner.
Raters filled-out paper-based forms during the assessments, shuffling back and forth through an average of 25 pages across two or more forms. Any computations were done manually, either during or after completion of the assessment. Results for every assessment were checked for quality (ensured data conventions followed and calculation were correct) by the project support staff. Assessment results were transcribed onto a result sheet and forwarded to the investigational sites (physicians) by fax. Objective data was entered by the support staff into The Sponsors’ (MedAvante’s Clients’) electronic data capture system. Sponsor representatives, also known as Monitors, visited or checked any computations done and verified data entered against the original source document.
This previous process posed challenges such as: having incomplete data, incurring computation errors, inconvenience of shuffling through multiple pages, and wasted time spent data entering previously collected information. This process was time consuming, error-prone, and costly.