MAIN5 and Iperion announce partnership to reorganize master data management
MAIN5 and Iperion Life Sciences Consultancy entered into a strategic alliance to better serve customers within the field of implementation of Regulatory Information Systems, data management, project management and change management.
“As the pharmaceutical industry faces organizational, technical and coordination challenges in an ever faster changing regulatory environment, the combined expertise of our companies will allow our customers access to top expertise with optimal communication possibilities,” Gero Neidlinger, partner of MAIN5 and Frits Stulp, managing director of Iperion Life Sciences Consultancy explain.
„Implementation of new regulatory guidance and new systems requires effective change and project management involving all stakeholders. The real change in our industry can only be made by understanding the roles of both regulator as well as industry side (including marketing authorization applicant, holder, and clinical research sponsor) and addressing the needs of the process. By combining the power of interoperable data with compatible processes, a real benefit can be achieved for the patient, and this is where our joint ambitions lie," says Frits Stulp. In addition, as IDMP data is cross-functional in various business areas and often distributed across different IT systems and even third parties, immense effort is required to identify and consolidate all IDMP-relevant information with most customers," Gero Neidlinger adds.
IDMP requires sustainable master data management and intelligent networking of product information, IT systems and processes. The objective is a 360-degree all-round view of the product data with homogeneous terminology and structure that will pay off doubly in the course of digitization. Both consulting companies are specialists in the digital transformation of the pharmaceutical industry, which is under heavy regulatory pressure.
The implementation of the ISO IDMP is phased in the areas Substance, Product, Organization and Referential Data (SPOR). Based on standardized data, a reliable exchange of drug information will be made possible and global interoperability ensured. There are several questions to answer in the respective pharmaceutical companies: Who in the company cares for which data, when, and how? In addition, IDMP stands in the future between previously independent software solutions of the various business units and requires common interfaces. "The decisive factor is a strategically oriented roadmap for sustainable implementation in the affected business units. Only then can synergy effects be used,” conclude Frits and Gero.