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KEY AREAS OF EXAMINATION
Data integrity is upheld through diligent examination, encompassing several critical areas: 1. Data exchange verification
Before each clinical trial, the interface between the laboratory’s Laboratory Information Management System (LIMS) and the central database undergoes testing and validation. 2. Ongoing data verification Throughout a clinical trial, collected data is subject to routine checks and comparisons with raw data to detect and address any discrepancies promptly. 3. Data file validation Any data files sent to customers are meticulously verified to ensure accuracy and reliability. 4. Change management Any alterations to data, such as data cleaning, are meticulously documented to provide a clear and traceable record.
CONCLUSION
In conclusion, partnering with a central laboratory offers more than just lab testing. It provides a comprehensive suite of services that not only streamline the data management process enhancing data integrity and efficiency, but also make it more cost-effective and secure.
By entrusting data management to experts in the field, clinical trial sponsors can be confident in their pursuit of comparable and valid data, ultimately advancing the development of new medical treatments that benefit us all.
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