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CLINICAL TRIAL MANAGEMENT SYSTEMS (CTMS)
A Clinical Trial Management
System, (CTMS), is a software system used by the
biotechnology and pharmaceutical industries to
gather, manage, maintain and report on large
amounts of data involved with the operation of a
clinical trial. CTMS manages the planning,
preparation, performance, and reporting of
clinical trials, while keeping up-to-date
contact information for participants and
tracking milestones for regulatory approval or
the issue of progress reports. Often, a clinical
trial management system provides data to a
business intelligence system, which acts as a
dashboard for trial managers.
Clinical trial managers have different
requirements that a system must satisfy. Most
requirements include: budgeting, patient
management, compliance with government
regulations, and compatibility with other data
management systems.
Sponsors have different requirements that their
CTMS must satisfy as well. Typically they
include: project management, budgeting and
financials, patient management, investigator
management, EC/IRB approvals, compliance with
FDA regulations, and compatibility with other
systems such as data management systems,
electronic data capture, and adverse event
reporting systems.
RealityCorp's proven testing
and validation methodology delivers
successful implementation of
CTMS 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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