Clinical Operations Audience
MEDIDATA CLINICAL OPERATIONS IN ACTION
64%
reduction in study build time
80%
or more reduction in data correction rates
60%
reduction in CRA time to reconcile ISF and TMF
70%
reduction in time to create monitoring visit reports
<30
days sites are paid
$146K
cost reduction per study from accelerating database lock process
POWER YOUR OPERATIONS WITH MEDIDATA
Operational Efficiencies
- Streamline end-to-end processes with automated workflows
- Any data entered once and seamless propagation across all
- Faster time to market with accelerated study set up and start up
Realtime Remediation & Transparency
- Centralized data, activity, and issue management for proactive remediation across stakeholders
- Clear indicators and reporting for smarter decision making and planning across all study aspects including financial health
Increased Compliance
- Improve inspection readiness by eliminating data reconciliation, system integration, and data transfer
- Real-time access to TMF documents when you need them. Realize Global Privacy, Security, and Regulatory confidence with SOC2+
OUR CUSTOMERS ON MEDIDATA CLINICAL OPERATIONS
“The Rave CTMS system will allow us to have all the information in one place. No longer will we have excel trackers, and specialized reports, that someone else is creating.”
Faye Woolf
Founder and Chief Executive Officer
“Rave Site Payments provided an interface that enabled our team to process, track and report on global site payments.”
Lori Eberhardt
Vice President of Operations
“Medidata delivers the right platform, expertise and services that will allow us to be competitive and aggressively scale our full service offerings.”
Nick Dyer
Chief Executive Officer
“Medidata’s unified platform provides us with the technology to scale our clinical research, address the complexity of today’s clinical trials, and build and maintain efficiencies.”
Amy Tseng
President and Chief Executive Officer
Nick Dyer
CEO, Catalyst Clinical Research, LLC
CLINICAL OPERATIONS
Study Managers
Effective cross study team collaboration with a single source of truth
Track, reconcile, report and forecast study milestones in one system
Seamless workflows, processes and technology with a single sign on
Efficient issue management with early identification, resolution, reporting and documentation
Inspection readiness with seamless audit trail and reporting
Global regulatory compliance
Risk Based Quality Management adoption and seamless execution
DATA MANAGEMENT
Data Managers
Real time data access and analytics for coding, safety management and insight based decisions
Centralized administration with role-based permissions
Control CRF design, data capture guidelines, data integrity checks, and document management.
Statisticians
Realtime unified statistical analysis, randomization schedule, endpoint modeling, study results, and document management
Programmers
Control data capture standards, integration, patient profile creation, programming specs, generation of TLFs, and document management.
SITE MONITORING
& BUDGET MANAGEMENT
Site Monitors
Centralized administration with role-based permissions
Faster assessments, training, monitoring, close out, and document management.
Supply Managers
Automated supply accountability with demand forecasting, packaging, labeling, distribution, returns, and destruction management.
Budget Managers
Control disclosure agreements, site master budget template, site contract management, site payments, and document management
Melissa Hancock
Director of eClinical Technology,
Aperio Clinical Outcomes
IN NUMBERS
6.3M Trial Subjects
780k+ Sites
14,000+ Total Complete Trials
70+ Study Therapeutic Areas