Iperion Named Strategic IDMP Advisory Partner in New Gens & Associates Program Offering Complete Regulatory Information Management Support to the Life Sciences Industry
European life sciences consultancy Iperion is one of just two strategic consulting partners globally to have been invited to join a new premier Regulatory Information Management membership program devised by Gens & Associates. Iperion will bring its unique IDMP data standard expertise, along with other relevant experience to the program, designed to help life sciences firms manage their regulatory obligations in a more cohesive and cost-efficient way as global requirements grow more complex and challenging.
Gens & Associates’ new Benchmark Premier Membership, launched in early October, will build on the company’s globally-renowned research into life sciences’ firms’ regulatory information strategies.Specifically Iperion will provide customized, practical guidance around IDMP and other emerging regulatory requirements. The idea is to help organizations tackle evolving e-submissions standards, global workflows and automated connections to enterprise resource planning (ERP) systems and other core applications, while containing the spiralling costs of compliance.
Share a common vision on data-driven approach
Commenting on Iperion’s role in the combined research/advice/implementation collaboration, Steve Gens, managing partner and founder of Gens & Associates, said, “I am absolutely delighted that Iperion is joining this venture. The life sciences industry is in great need of help to navigate its way through soaring regulatory complexity, and remove the growing burden of compliance on firms’ own experts’ time. Iperion has deep links with regulators across the global industry, and a clear vision of how companies need to move forward. Crucially, the company has a strong focus on the patient perspective across emerging regulations such as IDMP, which I believe will be a vital strand in guiding companies towards compliance strategies that do more than simply tick boxes.”
Frits Stulp, Managing Director of Iperion Life Sciences Consultancy and a prominent mover in IDMP circles, expressed his pride in being invited to join the consortium as one of only two global consulting firms. “Gens & Associates and Iperion share a common vision around assisting clients and their organizations in developing a data-driven approach to regulatory information management and compliance,” he said. “Together, we will be even better able to assist and accelerate our clients’ digital transformation agendas, and drive new levels of insights and innovation.”
Keeping patients central
He noted that keeping patients central to any plans, and harnessing technology in innovative ways, should be priorities for life sciences organizations. “This strategic partnership is about combining deep skills in business, technology and program strategy,” he explained. “The aim is to support clients through successful digitally-enabled process transformation, to deliver not only effective and cost-efficient compliance outcomes for those organizations, but also a better, more informed treatment experience for patients.”
As Program Manager of the first completed IDMP implementation program and a member of the EMA ISO IDMP Task Force, Frits is a leader in regulatory information management strategy.
Through the partnership with Gens & Association, Iperion will have an exclusive role advising on IDMP data standards and interactions with health authorities globally, and will serve as the primary Regulatory Information Management partner in Europe and the Asia-Pacific region. The company will also participate in RIM consulting in the US market.
Iperion will also be one of the guest speakers at the quarterly private webinar sessions, offered as part of the Gens & Associates Benchmark Premier Membership. The sessions are designed to provide timely updates and guidance on the latest regulatory developments to the life sciences industry and the software provider community.
About Iperion Life Sciences Consultancy
Iperion Life Sciences Consultancy, based in the Netherlands, is a global provider of consultancy in regulatory information management, managed IT services and cloud computing for life sciences. Its mission is to enable the industry and its regulators to innovate, improve business processes and optimize the supply chain, leading to faster and more efficient delivery of medicines and associated information to healthcare professionals and patients.
About Gens & Associates
Gens & Associates is a global life sciences consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance. Since 2007, the company has conducted 35 in-depth international studies into what constitutes World-Class Regulatory Information Management, and how life sciences firms’ plans are evolving.