End of Study Media - Rave EDC and Edge RCM

SIMPLIFY THE END OF STUDY MEDIA PROCESS

Part of closing out a study, and being compliant with regulatory requirements for NDA submission, includes End of Study (EOS) documents that a site must retain. Current business processes to produce, chronicle and deliver CD’s of the requisite EOS Media are manual and time consuming for sites, CROs and sponsors.  

The combination of Rave EDC and Edge RCM provides automation, standardization and controlled access for EOS documents.  

• Single Sign-on for data managers, CRAs and support staff

• Automated notifications to study monitors, sponsors and site users

• Comprehensive reporting and tracking of your site end of study data

• Controlled access for sponsors and sites to their study data

• New standard folder structure that will better organize EOS documents for migration to RCM

• Automated ingestion of EOS media into RCM using a scheduled process

The proactive automated notifications to sites to ensure timely collection and retention of documents.

rcm regulated content management medidata

IMPROVE INSPECTION READINESS AND COMPLIANCE

Often it is a scramble at the close of a study to gather the requisite documents.  This is avoidable with the use of Rave EDC and Edge RCM to serve as the content library.  All stakeholders have the requisite access to the approved and accurate documents for their respective uses.  

It is not a question of IF a site will be audited, but WHEN and they need to be inspection ready. The administrative effort to synthesize the required EOS Media into one central retention repository is significant.  The Rave driven RCM automated collection and notification process ensures sites have these EOS media, thereby ensuring compliance and eliminating allocated staff time.

BECOME PREFERRED AMONG SITES

Competition for sites is fierce with the increasing number of studies and a short list of high performing sites who can successfully deliver.  Making EOS Media retention turnkey is easily achieved by:

• Automating an event triggered by the Rave end of study milestone

• Providing automated notifications to reduce regulatory burdens

• Ensuring the EOS Media is delivered to the correct people

 Learn more about how you can be preferred among sites, click here.