How to achieve IDMP compliance

By 10. June 2016Blog

…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked in a few days ago. EMA has given us some more time to prepare via an iterative approach and we need to prepare data to be ready within 2017 at latest. Non compliance might be costly via penalties. Every European Marketing Authorization Holder should be having a clear IDMP strategy defined and ideally already kicked off the IDMP project.

Gartner, Inc., the world’s leading information technology research and advisory company., has published a whitepaper with very helpful recommendations. You can download an abstract or the entire whitepaper following this link:

http://blogs.gartner.com/michael-shanler/idmp-compliance-storm-is-brewing-for-pharma-in-the-eu/

The Cunesoft IDMP approach from technology and strategic perspective receives positive comments and recommendation within the Gartner report. Please see the brief extract below:

“ Today, there is no single vendor/leader or option for full IDMP compliance, but there is a small group of vendors that are familiar with the space (see Table 3). Some vendors entered into discussions before others and already have related domain expertise. Execution is a different challenge, but much of this has to do with project complexity and the type of engagement between sponsor and vendor. While having early experience appears to give credibility on the surface, very few clients have started moving an IDMP system into production. Just because a vendor has had early discussions doesn’t mean that it can execute well in your environment and with your partners.

  • IDMP and RIM products: Parexel and Aris Global were involved in many early discussions with Gartner clients; however, we now see other RIMS vendors with IDMP offerings, such as Cunesoft, Extedo, Samarind, Amplexor and Ennov, and discussions are rising in frequency. “

Should require help with you IDMP strategy, please contact us and let one of our IDMP experts challenge your plans.

Kind Regards,

Your Cunesoft Team