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Featured Resources
Patient Experience
Medidata Platform Fact Sheet
Back to Basics: A Survey of Clinical Data Management System Users and Decision
Makers

Featured Resources
Learn more about Medidata’s Decentralized Clinical Trials Program
Learn more about myMedidata
Watch our latest video on our Patient Design Program
Featured Resources
Learn more about Medidata’s Decentralized Clinical Trials Program
FAQs to Guide Your DCT Strategy
Medidata Circuit Clinical Partnership Factsheet
Featured Resources
The Big Book of CRO Case Studies
Find a Partner
Featured Resources
Revolutionary Synthetic Data
Patient-Level Trial Data + RWD
Accelerate enrollment
External control arm delivers hope in hard-to-treat cancer
Featured Resources


MEDIDATA CLINICAL DATA STUDIO


UNLOCK THE TRUE POWER OF CLINICAL RESEARCH DATA

Medidata Clinical Data Studio is a data management and quality experience that
provides seamless access to integrated data from Medidata and non-Medidata
sources. It leverages AI to streamline data aggregation, standardization, and
management workflows so that multiple users can review real-time data to shorten
timelines, reduce risk, and ensure safety.

Read Fact Sheet Watch Webinar Read eBook


BENEFITS OF CLINICAL DATA STUDIO


For Clinical Data Management For Clinical Operations For Medical Monitoring For
Clinical Programming & IT
For Clinical Data Management Expand


ACCELERATE DATA REVIEW AND ENSURE DATA QUALITY

With Clinical Data Studio, clinical data management has access to review all
clinical trial data in one place. Assisted by AI and automation, data managers
can shorten review cycle times by up to 80% per review cycle.

Read Fact Sheet
For Clinical Operations Expand


MANAGE RISKS AND IDENTIFY AND ACTION ISSUES EARLIER

Clinical Data Studio, with embedded AI and smart analytics, enables clinical
operations teams to centrally monitor, manage, and mitigate data quality and
patient safety risks.

Read Blog Post
For Medical Monitoring Expand


SPOT PATIENT SAFETY SIGNALS SOONER

Clinical Data Studio’s Patient Profiles enable medical monitors and safety
physicians to get closer to the patient journey with comprehensive narrative
profiles.

Read Fact Sheet
For Clinical Programming & IT Expand


REDUCE TECHNICAL COMPLEXITY AND BURDEN

Clinical Data Studio is an experience delivered on the Medidata Platform and
accesses Rave EDC data directly rather than adding another system and
integration to maintain. It can be up and running in as little as three days,
and its low/no-code environment means it doesn’t require expensive managed
services to operate. Instead, it reduces reliance on technical resources by
simplifying importing (from non-Medidata sources), integrating, and
standardizing data.

Read Blog Post


PROOF POINTS


90%


LESS PROGRAMMING TIME

Reduction in time generating listings

80%


AUTOMATED DATA REVIEWS

Reduction in data review cycle time

85%


MINIMAL CONFIGURATION

Reduction in KRI configuration time

3 days


SHORTER TIME TO ACTION

As little as 3 days to get up and running





KEY FEATURES OF CLINICAL DATA STUDIO

Clinical Data Studio positively impacts your data quality through features
delivered in a single, high-quality user experience.


Data Integration Expand


NO/LOW-CODE DATA INGESTION, STANDARDIZATION, AND TRANSFORMATION

In a no/low-code environment, Clinical Data Studio enables self-service data
import, validation, unit conversion, and custom dataset integration to aggregate
and standardize data from multiple sources (Medidata and non-Medidata) and make
it available to clinical data managers, central monitors, and medical monitors
for review and analytics.

Watch Demo
Data Review Expand


DATA REVIEW AND SURVEILLANCE

With Clinical Data Studio’s Data Surveillance capabilities, data review listings
are created without programming, Rave EDC queries are automatically generated,
AI assists with data reconciliation, data can be easily visualized, complete
patient profiles can be built, and progress in data cleaning can be tracked.

Watch Demo
RBQM Expand


RISK-BASED QUALITY MANAGEMENT (RBQM)

Clinical Data Studio brings your risk-based strategies to all your clinical data
in one place. Quickly configure and monitor KRIs (key risk indicators) and QTLs
(quality tolerance limits). Uncover site performance and compliance risks, using
AI to discover anomalies and unusual trends. Identify data quality and patient
safety issues sooner.

Watch Demo


WHAT OUR CUSTOMERS HAVE TO SAY


Moderna

“CLINICAL DATA STUDIO [FORMERLY DETECT] ALLOWS US TO PERFORM A DEEP DIVE INTO
THE DATA ANALYTICS. IT REALLY ALLOWS US TO SEE A FULL LANDSCAPE OF THE DATA.”

– Heidi McIntyre, Director of Centralized Data Monitoring, Moderna

Syneos Health

“WE NEED TO THINK ABOUT INCLUDING SAFETY, MEDICAL, CLINICAL, AND EVERYBODY ON
THE SAME PLATFORM, AND USING THE SINGLE SOURCE OF THE TRUTH. CLINICAL DATA
STUDIO [FORMERLY DETECT] PROVIDES US THAT CAPABILITY.”

– Haiyan Wei, Senior Vice President, Clinical Data Sciences

Aperio Clinical Outcomes

“WE LOVE MEDIDATA CLINICAL DATA STUDIO [FORMERLY DETECT]. I WANT EVERY SPONSOR
TO USE CLINICAL DATA STUDIO!”

– Melissa Hancock, Director, eClinical Technologies, Aperio Clinical Outcomes

Orion Corporation

“IT WAS IMPORTANT FOR US TO HAVE THIS ONE TECHNOLOGY WHERE EVERYBODY LOOKS AT
THE SAME DATA TO DRIVE OUR DECISION-MAKING PROCESSES. THAT IS WHAT CLINICAL DATA
STUDIO [FORMERLY DETECT] GIVES US. IT ALSO HELPS WITH OUR DATA REVIEW, AND
MAKING THAT FASTER, ENSURING WE ARE FOCUSING ON THE RIGHT AREAS.”

– Geneveve Nadeau, Director, UK Head, RBQM & Clinical Operations


LEARN MORE


eBook: 5Vs eBook: RBQM Article Demo Blog Posts Video Series
eBook: 5Vs Expand


A (R)EVOLUTIONARY PATH FOR DATA MANAGERS. THE GUIDE TO DRIVING DATA QUALITY
ACROSS THE “5 VS” OF CLINICAL DATA

The complexity of clinical trial data management has surged over the past
decade.

Data managers are navigating unprecedented challenges in capturing, processing,
and analyzing explosive volumes of data from an increasing variety of sources.

To stay ahead of the disruptive clinical trial data evolution, learn how
technology continues to inform and optimize clinical data strategies and
management processes with the “5Vs”—Volume, Variety, Velocity, Veracity, and
Value.

Download eBook
eBook: RBQM Expand


RBQM: THE CONNECTIVE TISSUE FOR DATA QUALITY

Just as our body is only functional when all parts work together in harmony,
RBQM can serve as the connective tissue of a given trial. This eBook explores
seven ways the human body inspires better data quality in clinical trials.

Download eBook
Article Expand


EMPOWERING TRANSFORMATION THROUGH TECHNOLOGY FROM CLINICAL DATA MANAGEMENT TO
CLINICAL DATA SCIENCE

This article outlines the evolution of clinical data management into clinical
data science, with data managers now being the stewards of all data and overall
data quality. It highlights the critical tenets of innovative strategies and
cutting-edge technology while ensuring a proactive, efficient, and insightful
data management ecosystem.

Read Article
Demo Expand
Click for sound





6:43











DEMONSTRATION OF CLINICAL DATA STUDIO

Watch Clinical Data Studio in action. See how automation and AI assist clinical
data managers, medical monitors, and central monitors to work with all clinical
trial data in one place, in a unified experience, to deliver data quality,
mitigate study risks, and ensure patient safety.

Watch Demo
Blog Posts Expand


CLINICAL DATA QUALITY BLOG POST SERIES

Read blog posts from Medidata’s clinical data quality and technology experts
discussing topics including patient centricity and data centricity, why data
platform architecture matters, RBQM, and AI.

Data Centricity Post RBQM Post Data Platform Post
Video Series Expand
Click for sound



3:34











BEHIND THE DATA

A video series delivering insights on the future technology of clinical research
– from the Medidata innovators who are shaping it. Real people, real solutions,
real stories, real innovation…Hear from the Medidata team about the future of
technology in clinical research and what is happening now that can drive your
clinical trial outcomes.

Watch Now
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