From one easy to use screen, clinical coordinators can see a complete picture of the trial(s) they are conducting including: the status of regulatory documents – what has been received, which are about to expire, upcoming appointments with the CRA, upcoming patient visits and schedules, and the latest enrollment information. In turn, the site can update patient visit data, inquire about the latest FAQs and alert the sponsor or CRO about screen failures or potential protocol deviations and adverse events. All data visible in the portal is in real time, providing up-to-the-minute information that may be critical to both the site and the sponsor trial team.

The Portal utilizes a secure log-in and security that ensures privacy of data, even between persons at the site. Those entering data to the trial can digitally sign forms and documents to comply with FDA requirements. At the sponsor or CRO, that information is passed seamlessly to the central trial repository where it is automatically incorporated into the database. There is no need for the sponsor to re-enter that data – it has already been checked and verified.

The Investigator Portal also includes an inter-site discussion forum and FAQ center to facilitate communication between investigators and sites, thus expanding collaboration between professionals and reducing confusion and unexpected outcomes.

The introduction of the Investigator Portal is an example of how Protocol Manager continues to lead the industry by offering the most functionally complete clinical trials management system. Protocol Manager provides end-to-end trial management from planning resources and budgets to financial and site management, monitoring, document tracking and time and expense reporting for all members of the trial team.