If you work in a regulated environment then the work you do will be guided by the policies and procedures outlined in your Quality Management System (QMS). Typically the QMS documents are embodied as a set of Microsoft Word or PDF documents stored on an intranet or (think of the …

If you are building studies in Medidata Rave, sooner or later you'll want to generate an Annotated Case Report Form so that you can communicate the study design with other team members who may not have access to Rave and to document the study data structures.

Some time ago we …

Despite the holiday season it has been a busy month at TrialGrid. We hosted two audits in July and our Quality Management System and approach to validation continues to be well received by Auditors. At the same time, we managed to make more than 60 changes to the system including …