Market Overview

No Need for End of Study CDs: Medidata Introduces NEW Rave Digital EOS Media Delivery

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Sponsors, CROs, and Sites Retain and Easily Access End Of Study Media
Necessary to Meet Regulatory Requirements

  • Reduces Regulatory Burden through Automatic Event Triggers from
    Rave EDC to Edge RCM
  • Edge RCM Automates and Simplifies Access to EOS Documents
  • Eliminates Need to Distribute and Use CDs for Clinical Trial End of
    Study Media

To ease and unify Rave End of Study (EOS) document management, Medidata
(NASDAQ:MDSO) today introduced a new, automated function of Edge
Regulatory Content Management (RCM). Triggered automatically from Rave
EDC, the new Edge
RCM feature
organizes, distributes and retains EOS documents to
maintain regulatory compliance and inspection readiness.

Today, the majority of EOS media is distributed on CDs. By combining
Rave EDC and Edge RCM, the EOS process becomes automated and unified on
the Medidata Cloud. This combination:

  • Simplifies the EOS document delivery method
  • Improves audit compliance by providing full electronic signatures for
    content delivery
  • Preserves media in accordance with regulatory requirements

"It is not a question of whether a site will be audited, but when.
Scrambling to gather the requisite documents at the close of a study is
a manual, logistical nightmare and compliance risk. By unifying Rave EDC
and RCM, we are digitizing the full study management process to enable
sites to streamline EOS document management and support regulatory
requirements," said Perry Steinberg, vice president, product management,
Medidata.

The new Edge RCM content library will streamline stakeholder access to
approved and accurate documents from Rave EDC. The features include:

  • Single sign-on for data managers, CRAs and support staff
  • Controlled access for sponsors/CROs and sites to study data
  • Automated ingestion of EOS media into Edge RCM using a scheduled
    process
  • Migration notifications to study monitors, sponsors/CROs and site users

About Medidata

Medidata is leading the digital transformation of life sciences, with
the world's most used platform for clinical development, commercial, and
real-world data. Powered by artificial intelligence and delivered by the
#1 ranked industry experts, the Intelligent Platform for Life Sciences
helps pharmaceutical, biotech, medical device companies, and academic
researchers accelerate value, minimize risk and optimize outcomes.
Medidata serves more than 1,000 customers and partners worldwide and
empowers more than 100,000 certified users every day to create hope for
millions of patients. Discover the future of life sciences: www.mdsol.com

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