Medidata Medidata

Medidata Detect

Medidata Detect

The power to proactively improve data quality and reduce trial risk

To oversee patient safety in a risk-based manner, Sponsors are relying on Centralized Statistical Analytics (CSA) to ensure the quality of their data and maintain compliance with ICH and FDA regulations.

Medidata Detect is a new and vital tool designed to improve data integrity and reduce trial risk. Through statistical algorithms and tests, you can uncover errors, trends, and anomalies in your trial data. 

CRAs gain the visibility required to proactively perform root-cause investigations and take corrective actions. Quality issues are addressed early, before they can be repeated, become systemic, and jeopardize the integrity of your study.

A foundational step in adopting a RBQM approach, Medidata Detect propels your ability to operationalize a patient-centric approach, folding patient input into all your drug development plans.

Fact Sheet

Inconsistent or missing data? Protocol violations or deviations? Your trial at risk?

See how Medidata Detect uncovers the data you need to trigger corrective actions that will minimize the financial impact of delays and unsuccessful submissions.

24% applications to regulators that require one or more resubmissions before approval

52% approved resubmissions that had inconsistent study results

435 days median approval delay after a first unsuccessful submission

5 days vs. ~4 weeks from LPLV to Database Lock when using CSA

83% reduction in case review time by Medical Monitors

20-30 minutes vs. 2-3 hours review time per case

White Paper

How can you monitor eCOA/ePRO data to improve data quality and reduce trial risk?

With a solution that exposes and helps you remediate unanticipated data anomalies, and give you a foundation for your RBQM strategy.

MEDIDATA DETECT IMPROVES EFFICIENCIES ACROSS ALL STAKEHOLDERS


Clinical Operations

Clinical Operations

  • Enable better workflow and data for central monitoring when using Rave EDC
  • Enable better workflow and data for central monitoring
  • Quickly identify risks and anomalies to take action
  • Preset risk category impacting patient health
  • See and easily understand data points
  • Initiate actions and track resolution
  • Benefit from intuitive navigation within the system

Data and Analytics

Data and Analytics

Data Management

  • Reduce number of edit checks
  • Reduce Database unlocks after initial database lock
  • Increase productivity identifying data anomalies and distributing data to clinical trial team

Programmer

  • Reduce time to extract, consolidate and clean data
  • Generate faster reports and analysis

Biostatistician

  • Shorten time required to perform data cleansing reviews and to identify data anomalies
  • Cut down LPLV to DBL cycle time for earlier NDA filing

IT

IT

  • Generate auditable filings with leading certifications
  • Get out-of-the box Rave integration
  • Leverage a single, scalable platform that consumes data wherever entered
  • Deliver consistent user experience with single sign-on

Syneos

Syneos Health and Medidata talk about strategies for implementation of eCOA with a solid foundation of technology, service and science