Medidata Introduces New Collaborative Workspace for Sites, Sponsors, and CROs to Manage TMF Content
January 22 2019 - 5:30PM
Business Wire
New Feature Creates the Only eTMF Solution with
Centralized Environment for Document Sharing
- Medidata is the first to offer a
centralized workspace to manage TMF content
- New feature enables real-time
collaboration on documents between sites, sponsors, and CROs
- The Medidata eTMF workspace reduces
cycle times and increases audit success rates
Over 35 percent of inspections are delayed because the TMF is
not complete or readily available1. To enable efficient, real-time
collaboration on TMF documents between sponsors, CROs and sites,
Medidata (NASDAQ:MDSO) today introduced a new workspace feature of
its eTMF solution.
As the industry's first regulated shared workspace, Medidata
eTMF supports document synchronization and accurate filing between
all trial stakeholders to maintain inspection readiness.
“One of the biggest challenges experienced by sites, sponsors,
and CROs is how to collaborate on managing trial documents. Our new
Medidata eTMF feature is the first and only workspace enabling TMF
content collaboration. All stakeholders will now increase
audit-ready accuracy and decreased re-work by managing TMFs
correctly from the outset,” said Perry Steinberg, vice president,
product, Medidata.
The new Medidata eTMF feature delivers a centralized location
for faster discrepancy reconciliation, document reclassification
and filing. Workspace benefits include:
- Documents are synchronized between
sponsors, CROs and sites
- Supports ICH E6 guidelines with
real-time monitoring of TMF status (completion, quality and
accuracy)
- Documents are managed and added through
a single interface
Medidata eTMF is connected to the full suite of Medidata
solutions, including Rave EDC, CTMS, Risk Based Monitoring and
Payments, delivering the industry’s most dynamic and comprehensive
real-time, end-to-end TMF management platform - unifying content,
data, and workflows.
Medidata is at the TMF Summit this week. Stop by booth 201 or
attend Medidata’s panel session (Jan. 24, 12:10 p.m. ET) on how
different companies apply automation, AI and machine learning
with:
Perry Steinberg, vice president, product, Regulatory
Content Management, MedidataAndy Chu, director, Regulatory
Affairs, Regulatory Systems Strategy, BIOGENDebra Wells,
manager, TMF and Compliance, EISAIRobert Willis, director,
Merck Research Labs IT, MERCK
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.medidata.com
1UK MHRA statement, 2014
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MedidataInvestors:Betsy Frank, +1
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