Medidata Offers Breakthrough to De-Risk Clinical Trial Submissions
May 08 2018 - 8:32AM
Business Wire
Medidata Edge Trial Assurance uses AI to find
data quality issues and helps resolve them before submission to the
FDA
To help organizations mitigate the risk of regulatory
non-approval and delays, Medidata Solutions (NASDAQ:MDSO) is
transforming how clinical trial data is validated prior to FDA
submission with Edge Trial Assurance.
For over a decade, fewer than 10% of clinical trials that enter
Phase I achieve FDA approval. Too many new drug submissions receive
a rejection letter, request for further analysis, or label
restriction, significantly delaying market entry, impacting
patients and shareholder value.
Often, these issues are not about the efficacy of the treatments
or devices but the quality of the clinical data. Medidata offers a
new way to preempt submission of data errors, by using machine
learning algorithms, put in the hands of Medidata’s team of former
FDA statisticians.
Medidata Edge Trial Assurance, already used in over 30 trials,
has consistently detected 50-75 data anomalies per study by:
- Utilizing Artificial Intelligence (AI)
to detect data entry errors, outliers, potential fraud or
misconduct and misreported adverse events from sites
- Delivering a turn-key, comprehensive
report of the results by a team of clinical analysts led by former
FDA statistical reviewers
- Enabling the study team to proactively
correct data issues before regulatory submission
Medidata’s AI capabilities have received industry recognition.
Recently, Medidata’s risk-based monitoring solution Edge Strategic
Monitoring earned a prestigious CARE Award for being the first and
only end-to-end solution that combines the same advanced anomaly
detection in Edge Trial Assurance with centralized issue
management.
“The outcome of a regulatory submission has a profound impact,
not only to the business but also for patients in need,” said Glen
de Vries, co-founder and president at Medidata. “Medidata’s
advanced machine learning capabilities and former FDA expertise
empower organizations to confidently manage regulatory submissions
and significantly reduce risk.”
About Medidata
Medidata's unified platform, pioneering analytics, and unrivaled
expertise power the development of new therapies for over 1,000
pharmaceutical companies, biotech, medical device firms, academic
medical centers and contract research organizations around the
world. The Medidata Clinical Cloud® connects patients, physicians
and life sciences professionals. Companies on the Medidata platform
are individually and collaboratively reinventing the way research
is done to create smarter, more precise treatments. For more
information: www.mdsol.com
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Medidata SolutionsInvestor:Betsy Frank, +1
917-522-4620bfrank@mdsol.comorMedia:Erik Snider, +1
646-362-2997esnider@mdsol.com
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