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ELECTRONIC DATA CAPTURE (EDC)
As the costs of clinical studies rise,
and the demand to quickly deliver therapies to
market increases, renewed emphasis is placed on
technology solutions such as Electronic Data Capture
(EDC) to control operational costs and expedite
time-to-market. By capturing data electronically,
and storing the data in advanced databases, key
clinical constituents such as investigators, sponsors,
research organizations and regulatory agencies gain access and visibility into study data
quicker
for earlier insight into the conduct of studies. In
turn, earlier insights enable study decisions to be
made in a timely manner during the clinical
development cycle.
Advanced EDC technology incorporates
streamlined study design, workflow, discrepancy
management, coding, integration standards,
regulatory compliance, and extensive reporting and
analysis into the overall solution.
RealityCorp's
proven testing and validation
methodology
delivers successful implementation of EDC system functionalities.
The methodology has been utilized in major
pharmaceutical and healthcare
clients since 2000.
Using RealityCorp's
methodology, clinical research
coordinators, trial monitors,
clinical data managers and project
managers can work more efficiently
and with greater accuracy.
RealityCorp's
advanced testing and validation
tools are designed to enable
sponsors to quickly asses potential
issues and act on data
earlier in the trial software development
cycle and manage development expenditures more effectively.
Leveraging the RealityCorp's
services
proven track record for scalability
and ease-of-use, organizations can
rest assured that when implementing
software of any type or size this
flexible solution will
accommodate their requirements.
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Streamlined implementation design and set
up
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Experienced management and
workforce
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Full support to enable
compliance with GCP, 21 CFR Part
11 and other regulatory guidance
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Support for CDISC integration
standards
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Extensive library of
configurable standard scripts
and ad hoc ability
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Ability to capture, manager and
archive results and reports
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Scalable architecture is designed to
support software and testing of
all types and sizes
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Available as an SaaS solution for rapid deployment or
enterprise adoption option for
in-house operation
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