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Infrastructure
Utilizing standard operating procedures and eClinical that streamline clinical trials.
Maximizing automation and minimizing manual activities.
Qualifying Systems Criteria Include:
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Seamless performance on activities
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Effective tracking & reporting
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Simple entry screens for site personnel
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Adaptable to protocol amendments.
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 GCP compliant training modules
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 CFR 21 part 11 compliance
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Data encryption surpassing 21.11
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