275 Grove St., Suite 101C, Newton, MA 02466
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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Sue Metz, Vice President Technical - 7.19.19 -
In my previous articles (Part 1, Part 2) we talked about the history of RIM and structural must-haves for a RIM system.
It’s also important to know the questions that will be asked of the data as well as ensuring that details around the various regulatory specifications are covered. As the saying goes, the devil is in the details. Sometimes it’s hard to decide what may be overkill vs. what’s absolutely needed that may seem like overkill.
Looking at the basic features of a RIM platform, holding aside usability and data details for now, a RIM platform must have the following features:
A bit new to RIM is support for IDMP, which is twofold. The Information Model needs to be able to hold and track data to be sent to authorities. Eventually, when guidance is provided by agencies, RIM will need to create IDMP files based on each agency’s requirements.
IDMP requirements do not stop there. Unlike XEVMPD where data is sent to the EMA after regulatory submission approval, IDMP files will be included as a file in a regulatory submission and not just initial or final submissions. The IDMP file will be included in all submissions making it part of the Lifecycle Operations. Data updates will be provided to agencies for the entirety of a regulatory event with the intent that reviewers will use both documents and data for their regulatory assessment. This means the RIM system must create the IDMP data file for each submission, have the ability to include it in the published output, and must also track the updated IDMP data against each submission (sequence). The system must be able to manage and show the lifecycle of the data in a holistic way. Plenty more to come on IDMP in a future white paper.
In my next article, I’ll go into more detail about each of the features described here.
"Anything to streamline this process is a real bonus. Look for tools that can publish globally, also those that can publish electronic, eCTD and paper from a single assembly – this is a huge time saver."
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We are always available for a conversation.