Data Capture and Management
REDUCE TIME, IMPROVE QUALITY, AND SAVE MONEY USING MEDIDATA’S DATA CAPTURE AND MANAGEMENT SOLUTIONS
64%
reduction in study build time
80%
reduction in data correction rates
44%
faster database lock cycle time
39%
reduction in manual source data verification volume
$297K
cost reduction per study from minimizing on-site travel cost
$146K
cost reduction per study from accelerating database lock process
THE POWER OF UNIFIED DATA CAPTURE AND MANAGEMENT ON THE MEDIDATA RAVE CLINICAL CLOUD
INTEROPERABILITY
Always inspection ready
Speed up submission readiness and reporting.
Real-time data and decisions
Automatically populate data in EDC for immediate action.
Automated randomization
Randomize patients in 3 clicks or less.
No reconciliation
Harmonize eCOA and other collected data in real time.
COLLABORATION
A single view for all
Enable cross functional signal detection for faster and earlier remediation of issues.
Compliance ready
Enable better adherence and compliance to the study protocol and regulations.
Better experience
Reduce risk while improving user productivity and efficiency.
SINGLE SOURCE OF TRUTH
One account
Login once.
One entry
Create unique identifier once that propagates across all applications.
One flow
Gain visibility and traceability across workflows.
SCALABILITY
Exponential benefits
Build reusable standard libraries and global dictionaries driving greater efficiency with reduced start-up timelines.
Highest productivity
Drive more efficient use of resources.
No mistakes
Eliminate inconsistent approaches to manual tasks through automation.
SECURITY, PRIVACY & QUALITY
Compliance
Improve compliance with GDPR requirements.
Version control
Reduce risks with single instance multi-tenancy.
Higher quality
Protect your study with an inspection-ready Quality Management System.
MEDIDATA’S UNIFIED DATA CAPTURE AND MANAGEMENT SOLUTIONS IMPROVE WORKFLOWS FOR ALL STAKEHOLDERS ACROSS THE CLINICAL STUDY
DATA AND ANALYTICS
Database Programmers
Support data capture standards, integration, patient profile creation, programming specs, generation of Tables, Listings, and Figures (TLF), and document management to support end-to-end study deliverables.
Data Managers
Manage CRF design, harmonize data capture standards, data integrity checks, and document management in a single place, reducing time and cost.
Statisticians
Access real-time data to support unified statistical analyses, randomization schedules, endpoint modeling, study results, and document management, driving greater consistency across statistical modeling.
STUDY MANAGEMENT
Clinical Managers
Improve timelines and efficiencies through real-time insights, reporting, and forecasting.
Study Managers
Reduce study build time and drive study planning and budgeting, milestone tracking, and essential document management across all stakeholders.
Supply Managers
Automate supply accountability with demand forecasting, packaging, labeling, distribution, returns, and destruction management.
INVESTIGATOR SITES
Physicians
Faster patient evaluations, clinical interpretations capture and sign off on case report forms, while ensuring patient safety and informed consent.
Nurses
Enhance patient visits through accurate and timely execution of study procedures, including administration of patients’ consent and other patient data capture with a single system sign on.
Patients
Enable faster and more accurate communication of medical history, clinical experiences, agree to consent, and patient reported outcomes that drives better compliance and patient care.
SITE MONITORING
Site Monitors
Reduce the number of site visits with faster assessments, training, monitoring, closeout, and document management on a centralized platform.
Device Managers
Better manage global device provisioning and support.
Simplified
Processes
- Single source of truth across all stakeholders
- No data reconciliation and no system integration
- Pre-validated eCOA global instrument library for standardized, pre-translated documentation
- Seamless data propagation, aggregation and reporting
Accelerated
Studies
- Faster study start-up, mid-study changes, and database lock
- Holistic data capture with alignment to workflows
- Ready for adaptive trials, re-randomization, and on demand supply management changes
Increased
Transparency
- Real-time data access for faster decision making
- Improved data quality
- Insight-driven process to support new paradigms for clinical trials
- Patient-centric design to drive decisions
Higher Return
on Investment
- Full configurability eliminates costly study disruption
- Higher predictability in forecast and budgeting IT costs
- Flexibility to use existing libraries and patient-owned devices
- Self-service approach to control vendor costs
“Medidata made us more efficient by enabling us to reallocate resources to focus on what’s most important – clinical research.”
Zlata Pavlova
Lead Data Manager
“Monitors on the trial were pleased to eliminate duplicate data entry and reconciliation between separate systems and we were able to improve efficiency in data capture.”
Koichi Saitou
IT Promotion Team Leader
“We can filter by site, we can filter by what’s been dispensed, and it’s really easy for us to track and access, everything is there in one place.”
Olivia Frank
Clinical Monitor
Dr. Miganush Stepanians
President and CEO
PROMETRIKA