During the last CDISC EU Interconnect in Amsterdam 8-9 May 2019, I experienced a confusion among many attendees and even exhibitors in miss-labeling the term MDR MetaData Repository. Talking among the attendees of the conference, it seems that nearly everyone has an MDR, but what they meant by it was differing widely. The most common kind of MDR being a library or collection of CDISC standards. The danger of miss-labeling your collection of CDISC standards as MDR is in that you would most likely miss on all the benefits that a true MDR has to offer.
A true MDR solution is the one where standards are not collected but defined, interlinked and properly managed and it extends far beyond typical CDISC standards like CDASH, SDTM, ADaM and CT. The most importantly, a true MDR solution must be based on the ISO/IEC 11179 standards. An MDR supporting the ISO/IEC 11179 standards is capable to define, manage and exchange any type of meta-data, not just CDISC meta-data consumed in a limited part of the Clinical Trial operation value chain.
With a true MDR solution, you can elevate your business to the next level where you would be able to tackle the most pressing Clinical Development challenges. The way you would do that is by integrating and interconnecting your entire meta-data value chain, end-to-end (E2E). By E2E we really mean to cover your entire development from Target Product Profile claims to the submission for the commercial license. Of course, within that scope, the entire CDISC standards are covered.
MDR MetaData Repository solution must incorporate the right Governance, Workflows and MDR ISO/IEC 11179 standards. Within MDR Platform, Pharma companies can manage their entire meta-data value chain and truly industrialize the process of Clinical Development of the bio-pharmaceutical products, from vision to clinical benefits.
We at intilaris, are proud to be supporting our clients to implement such meta-data management vision E2E and have been working closely with companies providing MDR technology to benefit from their technological innovations to support our clients.
For an in-depth conversation on this topic, please reach out to us.
