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Mithas Labs data management unit needs to spend a lot in hardware, software, leased line connectivity and skilled people. The sponsors looking at the data management business through outsourcing from India expects the following from the service provider.
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A detailed data management plan |
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Preparation of database in desired software |
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Comprehensive electronic validation and consistency checks |
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Data entry including double data entry |
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Query generation, handling, editing and tracking |
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Database lock |
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100% Quality Control of the efficacy parameters and safety data |
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21 CFR Part 11 compliant |
Each Sponsor looks at “21 CFR Part 11” compliant software to be used for their data management.
To ensure compliance to 21 CFR Part 11, Mithas should have proper clinical data management systems
with validated hardware and servers with proper performance, installation and operational
qualification documentations with User acceptance test (UAT). This further necessitates the
documentation of the training to the data management staff on servers, software, etc by a qualified
team of professionals, for which Mithas shall establish a training setup on CTDMS for both in-house and outside participant which Infact a clear source revenue for Mithas.
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