BK DM team are dedicated industry experts responsible for fast eCRF set-up, high quality data collection in accordance with timelines and regular status updates to the study team, giving a clear overview of the status at any time.
BK DM solutions ensure:
DM processes are based on Good Clinical Practice, EMA, FDA, ICH regulations and all other industry standards and best practices applicable for clinical systems and clinical data processing (including CDISC, ODM, and CDASH). EDC tool used is compliant with 21 CFR Part 11.
Quality and performance KPIs (examples):