Do incorporating CDISC and HL7 cause problems for clinical data managers in the pharmaceutical industry?
The move to industry standards permits more opportunity than problems. For bio-pharma, issues are sumarized and addressed in a recent PwC white paper: Research Rewired: Merging care and research information to improve knowledge discovery. February, 2008. A group which has established a standard specific to industry needs is the SAFE BioPharm Association (SAFE) which is is a non-profit consortium of companies that has established a digital signature & identity standard to allow for secure electronic transactions, virtually world-wide, across the biopharma & healthcare communities.(e.g., e-submissions, electronic trials, business transactions and e-health). You can find more information at their website.
