Data standardisation is cost saving by common sense
Due to the repetitive nature of clinical trials, standardisation is common sense. It saves time and thus it saves money. This is also true for data standardisation. Standardising data ensures efficient data exchange, and improved work flows. Errors are potentially prevented;
data consolidation is made easier and more consistent. Standardised data processing will improve data quality and result in considerable cost savings. In short the merits of data standardisation comprise:
- Increased data quality
- A familiar CRF reduces the number of errors and improve the work flow
- Significantly faster trial setup
- Re-use of standardised CRF modules decreases the amount of time needed for trial setup and testing
- - and trial termination
- The statistical programming can be re-used from one study to another, leaving time to focus on analysis
- Improved and eased consolidation of safety and efficacy data
- This regulatory requirement for safety data, is almost readily achieved through standardisation of data across trials
- Between partners during sales processes and due diligences
- Efficient data exchange
- From CRO’s and other suppliers
- Shorter assessment time with regulatory authorities
- Data standardisation may in the future reduce the assessment time as no time is wasted to format the submitted data
Conclusively, pharmaceutical businesses, biotech, and medical device companies undertaking clinical trials can profitably standardise their clinical study data. The question is then which data standardisation to choose. aCROnordic is convinced of the benefits of CDISC.