How to reduce major quality and productivity issues during ICSRs/Case processing and avoid duplication of work with whatever database you are working with?
By Global Placo
Published On 26 July 2019
Use the following simple tricks: ***Recaliber your Safety Database to:
- Automatically re-arrange the patient and drugs history (Past and Concomitant medication) once all the data is captured to the required order according to dates so that it’s easy to cross-check with the source and ensure no data is not missed
- Auto-rearrange the lab data according with units auto-generated based on the tests which are universally accepted For eg: if Blood pressure (B.P) is captured -mmHg is auto-populated in the units field
- Include the option to generate a narrative where the history and tests are generated in the tabular format (when cross checked with the entry in the fields and narrative, the data will not be missed for sure) If the data is huge and requires analysis and interpretation, the database can be adjusted and modified to get a report in particular format where it is suitable for incidence rates for IB/SmPC, PSUR, DSUR, Safety Data Analytics and Signal Detection and Risk Management without using a third party tools/Softwares.
Please contact me for any Quality, Productivity and Process Improvements.