Integrated Research Platform

All aspects of setting up and running studies are handled through the Integrated Research Platform.

Projects

A CliniSafe Project comprises all the settings and data collected for a study.

To facilitate collaboration, the CliniSafe Integrated Research Platform provides a “by invitation” security model,

which enables company personnel and external specialists to be invited onto a Project, with appropriate security rights.

CliniSafe is designed to run global clinical studies, by having either one or many Countries within a Project.

A CliniSafe Country is designed around the concept of Drug Rule Version.

A Drug Rules Version contains all the Drug Rules created for the study.

A Drug Rules Version can easily be copied to many Countries.

Equally a Drug Rules Version can be modified and allocated to just one Country to allow for any country to have specific rules for that country.

CliniSafe allows you to build Drug Rules quickly and easily using sophisticated Drug Rule Builder Wizards.

These rules are built from the drugs that are found within the Drug Databases

allocated to the study Project.

Extensive library of configurable reports, including Drug Rules, Drugs with Rules, Drugs without Rules, and many more.

Research Sites and the Investigators / site staff are quickly created, and maintained for the study.

Monitors can roam across the site within a Country, and can run the Wizard from within the Integrated Research Platform to undertake drug checking.

Users of the Integrated Research Platform must complete the Accreditation Program.

The Integrated Research Platform comes complete with on screen help at the system, page and field level.

The CliniSafe Integrated Management System includes over 120 SOPs.

Approximately 30 of these SOPs are used by CliniSafe when running or collaborating on studies.

These SOPs are published on the Integrated Research Platform should any other organisation wish to use them.