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integration services provider which designs, develops, integrates and maintains
business applications to enable enterprise solve complex, critical business
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ExcileCR-Clinical
Trial Automation Tool
More than 80,000 clinical trials alone are conducted in the United States per
year and about 95% of them are still paper-based. So it is not surprising that
as life sciences organizations seek ways to drive efficiency and improve
performance, one of the areas most closely scrutinized is the clinical
development process. Clinical Data collection and management currently account
for up to 60% of the overall clinical trial process, a timeline that drug
companies increasingly find unacceptable as they face increasing pressures to
test, approve, and market new drugs faster than ever before.
The business needs:
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Integrated clinical trial data, around 80 percent of clinical trials are paper
based with a variety of non-descriptive and in-housed developed software
applications
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To have access to the data real time from different sites of clinical trials
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To monitor clinical trial for effective management
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To comply with FDA’s CDISC standards, need mapping for FDA submission
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To comply with Security Design with 21 CFR part 11 and auditable
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To minimize noncompliance risks
The Solution - ExcileCR-Clinical Trial Automation Tool.
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ExcileCR application leveraged its expertise in clinical intelligence and
technology solution to develop, build and streamline the clinical trial process
by capturing, authoring, processing, and managing clinical trial data &
analysis.
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It is scalable, cost-effective solution that connects not only clinical
trial sites across multiple sites but also connects the Clinical Data
Management Team , Study Physician, Study Monitor, Clinical Co-ordinator,
Bio-statistical Team.
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By standardizing, controlling, and securing clinical trials-related
content, we designed a one-stop web-based Clinical Trials solution to
reduces the costs of data acquisition and clean up during trials, enables
real-time decision-making based on immediately accessible data, and ensures
regulatory compliance and faster submission preparation.
Business benefits
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Reduce the CRF design and review time by more than 4 weeks. Choose from
standard templates provided in eXcileCR.
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Reduce the number of resources for developing CRFs and printing cost
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Can Set alerts and rules for flagging events
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Distribute real-time information and educate all concerned stakeholders,
participants utilizing a customized web-portal
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Work locally but have access globally to make informed decisions
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Reduce the overall development trial (Lab to Launch). Currently the approximate
launch is around 12 years.
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ExcileCR based clinical trail process can help cut the time for trials by
two-thirds.
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