Medidata Medidata

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

Rave CTMS and Rave eTMF

POWER YOUR OPERATIONS WITH MEDIDATA


Operational Efficiencies

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

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

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

APERIO

“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

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PPD

“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
 

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Catalyst Clinical Research

“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
 

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TissueTech

“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

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Catalyst Clinical Research

A Paradigm Shift to Realize Intelligent Oversight

Nick Dyer
CEO, Catalyst Clinical Research, LLC
Clinical Operations Value Realized through increased operational productivity, early and unique insights, improved data quality, and decreased risk.


CLINICAL OPERATIONS Image

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 Image

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<br>& BUDGET MANAGEMENT Image

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

Aperio

"The integration of Rave CTMS and Rave eTMF will create efficiency and transparency for our sponsors."

Melissa Hancock
Director of eClinical Technology,
Aperio Clinical Outcomes

WHY MEDIDATA
IN NUMBERS

6.3M Trial Subjects


780k+ Sites

14,000+ Total Complete Trails


70+ Study Therapeutic Areas

130+ CRO, Services, and Partner Relationships

1,200+ Small and EBP Sponsors Globally