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Rexahn to Use MedAvante Centralized Ratings in MDD Phase 2b Study
Date:10/26/2010

By their nature, depression trial results can be affected by any number of variables, especially when subjective assessments are used.  That is why having central raters who are continuously monitored and calibrated can minimize rater bias," said Soni.  "We carefully evaluated different methodologies and found MedAvante Remote Centralized Ratings far superior to traditional methods."

"Centralized ratings are the wave of the future in clinical testing of CNS drugs," said Paul M. Gilbert, Chief Executive Officer of MedAvante.  "Our centralized ratings are backed with extensive clinical operations experience, professional project management capabilities, and proprietary infrastructure – all working together to fit seamlessly into Rexahn's existing study research design.

"We are confident that our unique ability to deliver 'true' centralized ratings can significantly reduce the bias and ratings variability associated with typical CNS trials – thereby providing a true reflection of both treatment and placebo effect," said Gilbert.

MedAvante's centralized raters diagnose subjects and evaluate symptom severity to ensure appropriate patient ascertainment and post-baseline standardization, the most difficult challenges to signal detection in CNS studies.  The raters are mental health professionals with deep clinical and rating scale expertise, carefully selected through an intensive qualification process, and continuously trained and calibrated to ensure optimal inter-rater reliability and minimize rater drift, a factor leading to inconclusive results in CNS trials.

Having set up over 600 remote sites worldwide, MedAvante supports each with a robust rater scheduling system to ensure blinding, and 24/7 global technology support.  MedAvante automated systems are 21CFR (part 11) certified and data privacy protection is US/EU Safe Harbor compliant.

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