Right now, Danish and European pharmaceutical companies are gearing up to comply with the ISO standards – designated IDMP – that come into force in the EU on 1 July 2016. The ISO IDMP standards require information from many areas of the pharmaceutical business, including regulatory affairs, research and development, manufacturing and distribution. NNIT and SAS Institute has therefore joined forces in a strategic collaboration to offer the pharmaceutical companies a unique means of IDMP implementation that builds on the expertise of the two companies.
NNIT, a leading consultancy, and leading software company SAS Institute have joined forces in a strategic collaboration on ISO Identification of Medicinal Products (ISO IDMP). This is because, from 1 July 2016, all pharmaceutical companies with EU marketing authorisation will have to comply with the new ISO standards, ISO IDMP, which will form the basis for a system of unique global identification of medicinal products. Combining NNIT’s insight into the regulatory area with SAS Institute’s experience of integrating and standardising data will enable the two companies to deliver a unique solution for the benefit of Danish and foreign pharmaceutical companies.
“The pharmaceutical companies face a big challenge in terms of integrating all their data from regulatory affairs via development to manufacturing and distribution," says Rune Bergendorff, Global ISO IDMP Service Lead at NNIT. "This requires departments in the company that historically have not exchanged data to establish a common terminology and interface, which usually is not already present. Moreover, experience shows that the information can be contained in up to 25 systems, which do not necessarily handle data in a uniform manner – not to mention all the information that exists in unstructured form in documents. SAS Institute’s long experience of integrating, linking and cleaning data coupled with NNIT’s profound understanding of the regulatory area and deep insight into data have enabled us to create the optimal platform for providing the pharmaceutical companies with the common data basis they need to be able to comply with the EU legislation from 1 July 2016.”
ISO IDMP is a collection of five ISO standards, which together form the basis for a system of unique, global identification of medicinal products. The main purpose is to provide a reliable means of identifying medicinal products and materials that are used in medicinal products. IDMP will impact a long series of key areas within a pharmaceutical company, from registration with an authority, research and development, to manufacturing, distribution and product safety, with data having to be supplied from many places in the company.
Unique collaboration leads to business growth
SAS Institute and NNIT are experiencing a high level of interest in this unique way of bringing together their expertise. As such, the new partnership is already in dialogue with a number of companies in Central and Northern Europe with a view to helping them to determine project scope, budget and resource allocation for implementation of IDMP.
”The pharmaceutical companies are facing an ever-increasing number of regulatory requirements relating to product safety, development and the actual manufacturing of medicinal products,” says Anders Helmø Larsen, Business Advisor for Life Sciences at SAS Institute. "IDMP is no exception to this, but an additional requirement. The particular challenge that IDMP presents to pharmaceutical companies is that data must be collected from many different parts of the organisation and standardised for IDMP purposes. SAS Institute has 40 years’ experience specifically in integrating and standardising data. Combining this with NNIT’s expertise will enable us to tailor the technology to give the pharmaceutical companies unique control of all the areas covered by the IDMP requirements. We can already see that we have chosen the right partner to be able to supply the best IDMP Data Hub solution to the market."
NNIT and SAS Institute have uncovered the key properties of the IDMP Data Hub solution, which will serve as the foundation for the overall IDMP solution. Work on preparing the platform for IDMP has already advanced to the stage where it is possible to start projects using real source data from pharmaceutical companies. NNIT is also training consultants in SAS's data management for ISO IDMP. Joint webinars, white papers and events hosted by the two companies will follow.
About the technologyAn IDMP solution consists of three main elements: a gateway for exchanging information between the pharmaceutical company and the authorities, an application to handle manual input of data, and a data hub for integration, cleaning and IDMP standardisation of data from different data sources (research and development, manufacturing, distribution, product safety, registration, etc).
The combination of NNIT and SAS Institute has resulted in a solution that can provide a rapid overview of data and access from many different data sources. The solution supports integration, cleaning and standardisation of source data for IDMP, and use and control of vocabularies (Controlled Vocabularies), allowing efficient data conversion in line with the IMDP requirements. SAS Institute has many years’ experience of ensuring that the relevant (structured and unstructured) data can be extracted from multiple sources and transferred to established terms/vocabularies that can be used for a specific regulatory purpose.
NNIT A/S is one of Denmark’s leading consultancies in IT development, implementation and operations. For over a decade, we have applied the latest advances in technology to make software development, business processes and communication significantly more effective. NNIT’s service offerings include advising, building, implementing, managing and supporting IT solutions and operating IT systems for customers. NNIT had revenue of DKK 2.2 billion in 2013 and employs more than 2,300 employees. 700+ employees work outside the borders of Denmark - in the Philippines, China, Switzerland, the Czech Republic and the US.
Read more at www.nnit.com
SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions, SAS helps customers at more than 75,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world THE POWER TO KNOW®.
For more than 30 years, leading life sciences companies worldwide have relied on SAS Analytics for drug discovery, clinical development, sales and marketing, and manufacturing.
Read more at:www.sas.com/dk
Business Advisor for Life Sciences at SAS Institute, Anders Helmø Larsen, mobile: +45 51 38 78 63.
Global ISO IDMP Service Lead at NNIT, Rune Bergendorff, mobile +45 30 75 17 47.