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| CLINICAL DATA MANAGEMENT |
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| 08. What is unique about our CDM compared to the ones in the market? |
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| Manipal provided end to end solution in CDM. |
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| 09. Which are the versions that are older than this version that are still used in the market? |
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Oracle Clinical 4.5.1 S A S 8.1 WHO DD 1st June 2005 MedDRA 8.1 |
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| 10. How are the systems (Quality Systems/processes)
that we follow able to deliver quality information in the
prescribed time frame? |
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| The quality documentation is sufficient to assure consistent
application and methodology in the use of quantitative tools
to measure data quality. The quality plan results in a reproducible
quantification of the data quality and documentation that
the data quality is error free. |
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| 11. Do we customize the data programs to
suit the needs of the client or is it fixed template that
we follow? |
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| We have a fixed template for data programs, however upon
sponsor request we may customize to suit their needs. |