In drug development process the importance of high quality and accessibility of clinical data is not only a best practice but a critical mission to adhere. In today’s world clean & arranged data offer real opportunity to design better studies using existing data and to plan safety strategies. The ultimate outcome of the clinical trials is directly related to parameters like collection, storage and easy retrieval of the data. To match the global data standards along with its high integrity, specificity and quality, the processes must be in-line to meet the regulatory requirements and CDISC/SDTM standards. The use of CDISC/SDTM standards enables sponsors to conduct rapid, time efficient and cost effective clinical trials.
This webinar has covered
- Data standardisation requirements – Regulatory perspectives
- Advantage of adopting CDISC data standards
- Bioequivalence study data submission requirements