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.

Benefits of Clinical Data Studio

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.

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.

Spot Patient Safety Signals Sooner

With all the data in one place, sponsors, medical monitors, and sites can easily set up and visualize the patient journey with comprehensive patient narrative profiles.

Clinical Data Studio provides medical monitors with a full view of efficacy and safety trends across all aggregated patient data. This allows them to identify unexpected and emerging patterns and spot potential patient safety issues. They also gain access to oncology-specific analytics and dashboards to explore complex RECIST 1.1 data easily.

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.

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

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.

Data Review

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.

RBQM

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.

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

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.

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.

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.

 

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.

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.

 

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.