Winchester will announce the newest version of its flagship CTMS product called Protocol Manager at the 44th Annual DIA Conference in Boston on June 22 to 25, 2008.
CTMS on a Stick . . . When you need an "offline client", Protocol Manager client is now available on a USB 2.0 flash drive. The big impact for small biotechs and CROs is that they will not need to provide a new laptop to each CRA on a trial.
The sponsor or CRO may issue the complete offline client on a flash drive that will work with the Windows operating system.
Investigator Portal . . . The Investigator Portal helps prospective investigators to review limited trial information prior to applying as a candidate to investigate a trial. The portal helps the trial team with the recruiting task. Once recruited, the portal provides access to the Investigator Site only information about staffing, correspondences, calendar events and appointments, patient statuses, and patient visit information. Depending upon the needs of the trial, the Investigator Site may enter patient enrollment, screening, and visit information directly through the portal. If the trial is using an EDC system or an IVRS, an interface adaptor is available for most commercially-available systems to allow the direct interface of patient enrollment, screening, and visit information as soon as it is available. This makes the CTMS the "one place" to look to determine all trial metrics regardless of how many and which systems have been deployed. Plans for the next release of the Investigator Portal is to assist with the provisioning of sites and direct "single sign-on" capabilities through the portal, stay-tuned!
Trial Team Portal . . . In addition to the Investigator Portal, the Trial Team portal allows monitors and other field personnel to work with respective documents and information using an Internet Browser to access the web-based Protocol Manager. The portal is entirely web-based. The trial team member connects with the CTMS over the Internet.
Extended Design and Dashboards . . . For the trial team member who wishes to see only the data and information the pertains to them, trial role-sensitive dashboards quickly provide access to the users' information.
SaaS Hosted Model . . . Protocol Manager is now available as a "hosted solution" with two models. One model applies the CTMS to the "by the trial" approach. A sponsor or CRO may essentially by hosted CTMS availability and services on a trial-by-trial basis. The second model is the "hosted enterprise" model. The sponsor or CRO buys an enterprise license for the CTMS and also buys hosting services to use the system.
Many other feature additions and extensions comprise the latest release number 8.5. As details become available, they will be listed in the product's release notes.
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