Clinical Study Portal connects users to all clinical trail systems Boston, MA, October 23, 2008 – Winchester Business Systems, the leader in global clinical trial management systems (CTMS), today announced the availability of its Clinical Study Portal. The Portal provides the much-needed common connection between clinical trial systems from disparate vendors. The Clinical Study Portal offers one central website for all users to log in with a “Single Sign On” to one common authentication process. A consensus by both study teams and sites, “What we need is one place to go for all of my clinical information.” In today’s technology-driven environment, investigator and sites clinical study teams are being asked to use the systems supplied by four or five different vendors on a given clinical trial. Besides different technologies, the study teams and sites are required to have different IDs and passwords on each trial and each system. Study team and sites are experiencing a labyrinth of URLs, IDs, usernames, and passwords to keep straight to obtain the necessary access to review a clinical trial’s information or make data entries. This is the exact problem that Winchester addresses in its newly released Clinical Study Portal. The direct linkage between the Clinical Study Portal with Winchester’s CTMS combined with a set of single sign on parameters supplies a central point for: - Search and apply to active trials - Online feasibility studies, questionnaires, and applications - Online regulatory documents - Secure correspondences and emails - Study discussion threads - Online study reports - Study-specific calendars - Frequently-asked questions - Online training - Online meetings - Integrated links to online EDC and IVRS tools - Access to central data repositories Winchester’s Clinical Study Portal timestamps and tracks all user activity. It provides the study team with information about site progress throughout each study tracking site progress across multiple studies. To track site progress, study teams just need to log in and access online site study and progress reports. Links to all other eClinical systems -- Clinical Study Portal users are authenticated against their specific trial assignments and are linked directly to the Electronic Data Capture (EDC), IVRS, adverse event reporting system, CTMS, and other clinical trial systems without being authenticated again. Sponsors, CROs, Labs, IRBs, ECs, and contract personnel, once authenticated by the system, can also participate in this “role-based” system using their Internet Browser. The Clinical Study Portal is based upon Winchester’s latest release 8.5 of the flagship product called Winchester’s Protocol ManagerTM. Protocol Manager is a web-based CTMS comprised of most ERP functions, contract management functions, investigator relationship management components, regulatory document tracking, clinical trial monitoring, inventory management, and financial processing. Configured to Fit the Client -- The Clinical Study Portal is completely configurable for and by the company that is managing the trials. The Portal can have the same “look and feel” as the company’s own webpage providing all of the linkages to the necessary eClinical systems. All clinical users log in to a single Clinical Study Portal deployed specifically for the company that is managing the trial. The Portal determines who they are, what access they should be granted, what clinical trials they are assigned to, and what role they may perform on the trial. The Clinical Study Portal automatically determines which EDC, IVRS, CTMS, LIMS, CDMS, EDMS, and other eClinical systems that are appropriate for the specific trial the user wishes to access. The authenticated user is routed to the appropriate systems based upon the user’s request. As the user has been already authenticated, the EDC and other target systems do not need to authenticate the user again. The Clinical Study Portal can provide the linkage to a CTMS that has been previously been deployed as the company’s principal trial management tool. “The Clinical Study Portal is Winchester’s latest offering to help streamline and speed up the clinical trial process,” said Michael Regentz, Winchester’s Managing Director. “If a user is authenticated by the Clinical Study Portal, the Clinical Study Portal provides the proper electronic keys to unlock the other multiple-vendor-supplied clinical systems on a trial for that user. One username and one password is all that is needed.” Scalability is the Key -- Winchester’s Protocol Manager is used by Biopharmaceutical companies around the globe on trials that range from single site Phase I trials to Phase III trials with over 15,000 patients, 1,000 sites, and in 13 countries at once. Winchester’s Protocol Manager includes an “Internet Cluster Manager” (ICM) that allows for a large number of users to pass through and use the Clinical Study Portal at the same time. The ICM helps to balance “large user loads” which include field monitors, investigator sites, etc. Winchester’s Protocol Manager is “highly scalable” to trials of 10,000 to 20,000 and more patients. Some customers have exceeded 800 active simultaneous trials in a single deployment. For nearly 15 years, users of Winchester’s Protocol Manager have been able to access the system over the Internet using a “thick client.” Over the 15 years, Protocol Manager has evolved into the most comprehensive CTMS available today. Winchester’s customers that are using this new release of Protocol Manager believe that they are on the “cutting edge” of the next generation of technology that is used to manage the myriad aspects of clinical trials. According to Mr. Artem Loshak, Product Manager at Winchester, “The Clinical Study Portal and Protocol Manager web-enabled system can replace the multiple spreadsheets and local databases that are set up to manage the various aspects and documents involved on a clinical trial. The direct linkages between the Clinical Study Portal and the other clinical systems helps to streamline the management of clinical trials.”