Clinical data standards seem wonderful in the abstract. On a white board, the work of CDISC and HL7 should make life easier, cheaper and faster for everyone involved in any clinical trial, just as broccoli should be good for anybody’s health. Thinking about buying broccoli is more common than buying it. That’s surprising, given the FDA’s encouragement to use CDISC’s study data tabulation model (SDTM) standard.  Almac, with headquarters in Northern Ireland, has been buying the broccoli and serving it. “Clients have their own standards. We are starting to see more and more where the standards are shifting to the SDTM,” says Sheldon Witmer, group leader in Almac Clinical Technologies clinical project services department. Growing Confidence In EDC The same is true of the use of electronic data capture (EDC) in general. “Most companies know this is the way to go,” he says. “They’re not questioning whether to do EDC. It’s…more...