TrialDriver
SharePoint™ Clinical Study Portal

Developed by GCP-MB linkarrow
Solutions and Services for Global Clinical Trials

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TrialDriver SharePoint™ Integration

Microsoft’s SharePoint™.product has matured over the years to be the web-based collaboration framework of choice, providing the document management and teamwork tools essential for small Pharmas and Biotechs, especially for those which are organized into low-overhead, “virtual” units. Efficacy.ch has developed a standard 3-level portal structure which reflects a company-study-investigator hierarchy.

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Study Portal Top-Level screen

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TrialDriver Clinical Portal

 At the top level of the Portal - the Company level -  it leverages the most essential SharePoint collaboration tools, such as Calendars, Contacts, Task Lists and Issue Trackers. This basic structure can be further refined or extended according to client requirements.

SharePoint provides a Document Repository for storing and sharing company and study documentation and which integrates seamlessly with the standard Microsoft Office programs. It includes basic document management functionality which provides most if not all such capabilities required by small companies, thus avoiding the overhead of fully-blown document management systems.

Most critically, the SharePoint Study Portal provides a web-based window into the TrialDriver Data Management system, so that reports, CRF images, queries and other data can be called up in real time.

Live Data Statistics from TrialDriver

Clinical Study Management Portal

At the second level - the Study level  - the portal provides a “Reports and Listings” area which gives real-time access to the underlying TrialDriver data management data for the current study. CRF images can be called up for scrutiny, as can many real-time reports

Query tracking eliminates much uncertainty between Data Management and CRAs and ensures that everybody is on the same page. TrialDriver-generated Data Clarification Forms are stored online and can be accessed by authorized personnel. Automatic E-Mail notifications ensure that changes are flagged to interested parties.

Catalogs of Self-Evident corrections can be collaboratively developed using basic SharePoint issue tracking mechanisms, which allow for versioning and approval workflows. SharePoint document management capabilities allow sharing of study related material

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Investigator Portal

At the third level - the Investigator level - the portal allows individual investigators to log in securely to their own private areas, where tools are provided for investigators to call up study data related to their own sites and to enter data which feed into the CTMS database.

Interactive web-based randomization is available, as are tools to access site queries and enter subject milestones. The investigator portal is also integrated into the TrialDriver EDC application, thus providing a rich online environment for participating sites and investigators.

Custom functionality can be developed on demand