The pharmaceutical industry has notoriously been renowned for playing the “slow adopter” role in terms of IT. The price of implementing and updating GxP systems seldom leave financial or organizational leeway to engage with new innovative IT solutions. This is further supported by the conservative incremental innovation frustration and short-sighted silo based solutions.With ISO IDMP (Identification of Medicinal Products) the time has come for the industry and regulators to join forces toward building the foundation that collectively will improve patient safety and bring pharma into the 21st century.
The pharmaceutical data standardization ecosystem (e.g. SDTM, SEND, Allotrope, xEVMPD & MedDRA) supports the continuous requirements for a common understanding and capability for the data interchange between regulators and industry peers. These are based on and support narrow business/regulatory requirements.ISO IDMP will blur the lines and drive the collective industry movement toward enterprise pharmaceutical Master Data Management (MDM).
Most companies that historically have embarked on enterprise wide MDM initiatives have failed either because the benefit realization was wrapped around a myriad of thought up assumptions or because the organization simply was not ready. MDM has as a concept, however, slowly been accepted and increasingly organizations within pharma have adopted the principles primarily within finance and supply chain/manufacturing. So how can you leverage ISO IDMP to move MDM horizontally across the enterprise?
With more than 20 IDMP projects, NNIT understands both the technical and business aspects of IDMP. By perceiving IDMP as an Information Management project, we firmly believe that real opportunities await companies that look beyond the regulatory requirements and adopt the IDMP principles across the organization.IDMP is MDM and we have the global services portfolio to support this journey.
We build the MDM roadmap with you while taking into consideration external regulatory IT initiatives (e.g. EU Telematics strategy, PDUFA V etc.). This includes a thorough evaluation of your current and future state MDM maturity as well as a recommendation of the right MDM implementation style.
We have the capabilities for supporting the technical implementation and supporting the MDM path that you have embarked on. Building data objects and attributes into a tailor made information model and configuring your preferred technology.
We build the governance model and MDM principles required to ensure a smooth operational implementation. Facilitating the data ownership process, writing SOP’s or leading the organizational change management efforts – we have the skills and experience to support all of the levels of operational implementation.