Safety is a key in any clinical trial. And so are Safety documents. GRAVITY holds an in-build SUSARs management system which ensures that safety information is available to the in real-time and is acknowledged by a PI(e-signature). This assures that every site is aware of the safety implifications of the study on an on-going basis. Robust tracking and report generation specific for SUSARs helps in avoiding the use of multiple systems of safety management.
when a site is selected for conducting clinical trial, Documents start to flow in, however, the initial pack of essential documents require maintenance, For example, CVs are only valid two years. It is time consuming and expensive to track these manually. GRAVITY incorporates a unique features of overseeing the essential document management and alerting the users of expiring documentation ensuring documents are up-to-date.
Developed based on TMF reference model, in-line with, ICH-GCP and regulatory Requirements.
Efficient uploading, Sharing, Maintanence, Review, Tracking, Retriving, Archiving.
A single access for all functionalities.
Reduces time and resources in document management both on-site and off-site.
Dynamic reporting system.
Logical flow and user friendly.
Unique and simillar to the management of paper based filing. Hence its user friendly.
Assure that site has access to the correct study documents at all time.
Utilizes dynamic log and forms, reports and trackers.
Reduces time and resources in document management.
Role specific access and e-signature.
Easy but controlled access. Assures security.