In August, Gens & Associates published a special report[1] which painstakingly assessed 11 software providers’ readiness to support life sciences companies across 22 different IDMP-related requirements as the deadline for EU compliance draws nearer. And we’re delighted to report that, of the 3 companies who meet 22 IDMP requirements reviewed by Gens & Associates either now or within the next 6 months, 2 of them (Generis and Extedo) are based on the Generis configurable CARA Life Science Platform.
The Generis CARA Life Science Platform provides comprehensive support for:
· The IDMP data model
· Organisations Management Service (OMS) & Referentials Management Service (RMS)
· FHIR messaging
· PMS message submission (due Q4 2021)
· Simultaneous XEVMP and IDMP reporting (due Q4 2021).
Data-driven by design
Interestingly, Generis and Extedo are two of only four software providers who offer both support for the full ISO IDMP data model in all its complexity, and yet take the approach of capturing all of this detail as part of routine daily regulatory processes (rather than as a distinct activity towards IDMP/SPOR compliance).
We believe that this approach - making RIM / Regulatory the source from which everything required for IDMP is captured as part of a natural business process - is the most “painless” strategy for collecting data, especially given the ease of data entry and collation in CARA: the platform enables all data objects to have their data compiled into an IDMP submission at a single click.
Leading the way – via easy configuration as requirements evolve
We’re incredibly proud to have achieved this compliance with industry requirements to help our clients navigate an IDMP-compliant data-driven future. This is all down to our readily-configurable, platform-based approach to Regulatory Information Management (RIM) - not to mention Quality, Safety and Clinical information and content management - which form the CARA Life Science platform.
Unlike other software vendors, we don’t have to hard-code new fields as part of the system logic each time there is a change or update to the IDMP requirements. We can absorb each incremental development via simple configuration in a matter of days: that’s how we’ve been able to keep on top of the most recent updates, continuously paving the way for client compliance.
There’s more to come
On top of all of this, in Q1 2022 Generis will be introducing the capability to extract information using AI from documents such as the Summary of Product Characteristics (SmPC) for populating the data model for RIM/IDMP.
We’re also keen to tell you more about our new standalone SPOR offering, due for release in Q4 this year, which I’ll explore in a forthcoming post - watch this space!
In the meantime, the comprehensive new Gens report, 2021 IDMP Software Provider Readiness & Capability Assessment, which runs to 64 pages and goes into fantastic detail, is available for purchase from the Gens & Associates web site at http://gens-associates.com/.
[1] 2021 IDMP Software Provider Readiness & Capability Assessment, Gens & Associates, August 2021: http://gens-associates.com/