BioStat Solutions, LLC chosen to perform Electronic Data Capturing (EDC) and statistical analysis for upcoming Saline Fill Breast Implant IDE.

BioStat Solutions, LLC of Damascus, Maryland has been chosen by Cosmetic Surgery Suppliers, Inc to provide EDC (electronic data capturing) and statistical analysis for their upcoming Saline Fill Breast Implant IDE. This 1200 patient, multi-site trial will benefit from the increased efficiency and accuracy of BioStat Solutions' eCRFStat software.

DAMASCUS, Maryland (August 1, 2003) - BioStat Solutions, LLC (http://www.biostat-solutions.com) has been retained to provide electronic data capturing (EDC) for the upcoming Saline Fill Breast Implant IDE of Cosmetic Surgery Suppliers, Inc (CSS). BioStat Solutions is a nationwide biostatistic and data management consulting corporation dedicated to serving the pharmaceutical and biotech industries in data management of clinical trials and medical device development along with data analysis and subsequent statistical interpretation.

BioStat Solutions will provide its data collection and statistical analyses capabilities in evaluating the Investigational Device Exemption (IDE) for CSS and the Sebbin Laboratories Saline-Fill Breast Implants. This IDE is a prospective, multi-site clinical trial involving 1200 adult patients and will determine the safety and effectiveness of the implant in women who are undergoing breast augmentation, primary breast construction, or revision.

"It is amazing that data collection of the clinical trials run worldwide is still performed predominantly using paper-based methods" said Ron Bromley, BioStat Solutions Vice President. "BioStat Solutions recognizes that web-based electronic data collection is faster and, of critical importance, results in cleaner data. Thanks to automated data checks on submitted information along with real-time data analysis the trials can be guided dynamically not passively. Clinical studies using our flagship EDC software known as 'eCRFStat', benefit from increased efficiency, accuracy and ease of use by utilizing automated edit checks for out-of-range values. Our clients also have the ability to perform real-time data review and analysis thereby guiding their AS IT PROCEEDS, not after! This helps accelerate advancement between clinical phases, and potentially shortens the processing time for drug or medical device approval for our clients."