| Some of the key concerns with clinical trials include Regulatory Compliance, Adverse Event Handling, and Document Management. |
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| Cognizant's Regu-Lite tries to address some of the concerns surrounding clinical trials. At a very high level, the Regu-Lite Framework is a holistic approach to compliance management in the clinical trials spectrum that encompasses: |
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- Standards - Best
practices and guidance for how to determine
the appropriate level of specifications,
procedures, and record keeping detail
that is really necessary and valuable
- Tools - Products
that automate common, repetitive tasks
- Scoping - Definition of system boundaries
and the applicability of validation
vs. standard SQA
- Training - Project
team education materials and methods
- Risk-basing –
Determination of system risk based upon
a prescribed, rational process
- Scaling –
Selection and sizing of tasks to meet
the defined level of system risk
- Support - Ongoing
improvements to incorporate common experience
and the latest aids
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| With extensive domain, technology, and business process expertise in the Healthcare and Life Sciences industry, Cognizant is the preferred partner for several pharmaceutical companies. |
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