In my last post, I provided an overview of metadata repositories (MDR) and the driving factors for industry to adopt them.

As a recap, some of the key MDR drivers are regulatory compliance, regarding submission of clinical data in CDISC standard format, and automation for improving business efficiency. However, to achieve these goals, the traditional process of managing standards in spreadsheets within functional silos must change.

I led one of the first MDR implementations in the industry at a sponsor organization about eight years ago, and I have implemented MDRs at multiple organizations, including sponsors, a CRO, and CDISC. I also had the opportunity to work with many other organizations on proofs of concept, pilots, and consulting engagements, many of which involved Oracle customers. I have seen first-hand what the risks and challenges are in planning, implementing, and successfully using an MDR.