Veeva’s Commitment to Supporting IDMP in 2020
As we continue to track the EMA’s progress towards IDMP implementation, the Veeva Vault RIM team is dedicated to providing support for evolving regulatory data standards through our unified suite of applications. This includes our data model for regulatory data capture that was first designed based on the 2012 ISO standard, but that we’ve since expanded to include customer feedback and business best practices for registration data tracking and management. Rather than strictly adhering to the ISO structure, we’re focused on accommodating IDMP data points in the context of regulatory data management as well as pulling in information from other systems through Vault’s open application programming interface (API). This gives our customers more flexibility and resilience over time.
Veeva customers that are managing XEVMPD in Vault are already populating about 70% of the EMA’s recommended IDMP Iteration 1 fields today. We will add other Iteration 1-related data entities to the Vault RIM Suite in 2020, and we’ll enable features that support IDMP data generation, review, and submission in the coming major releases in accordance with EMA implementation guide updates.
While some systems treat IDMP and other data reporting formats as add-on modules, Veeva views these as critical components of end-to-end registration tracking. By doing so, we enable our customers to capture the data they need for day-to-day operations and to utilize that data in different ways. This means customers will be ready to publish data in multiple formats, whether it be to meet IDMP standards or other global regulations.
In the coming year, Veeva looks forward to releasing new updates to further support XEVMPD data handling and IDMP. As the EMA releases version 1 of the implementation guide and continues to work on version 2, Veeva will share more details around relevant timelines. Our goal is to be IDMP-ready for the optional submission timeframe, which is currently expected to be late 2021 or early 2022.
To learn more about how Veeva is supporting IDMP efforts, click here.