NNIT: How to Improve Drug Quality Management with Information Technology
To be concerned with everyone’ s life and health is a serious cause for the pharmaceutical industry. The government has imposed strict supervision of the pharmaceutical industry as well. Therefore, guaranteeing the quality and safety of the products is the cardinal task of pharmaceutical enterprises.
But how can the quality and safety of products be guaranteed? Obviously, a good solution would be to produce the products according to international state-of-the-art standards and methods.
NNIT, an All-round Consultancy Service Company
NNIT is a leading IT consultancy service company in Denmark which is dedicated to providing all-round services to the customers, including consultation, development, implementation, operation, etc.
Originally, NNIT was the IT department of Novo Nordisk. Through continuous development, it has evolved to a wholly-owned subsidiary which was listed in 2015, thus becoming a public company owned by Novo Group. NNIT realized its “triple jumps.” In 2015, NNIT’ s income reached 2.6 billion DKK. NNIT’ s staff exceeds 2,500, among which more than 900 employees are in China, the Czech Republic, the Philippines, Switzerland, the United States of America, etc.
Focusing on IT Consultancy Service for Medicinal Product Quality
Guaranteeing quality and safety of medicinal products is supposed to be the top concern and priority of pharmaceutical enterprises all the time. However, sometimes things go contrary to one’ s wishes.
The 2015 Drug Inspection Report, issued by China’ s Food and Drug Administration (CFDA), showed that the first pass rate of GMP certification is at a three-year low, with the main deficiencies focusing on quality control and quality assurance (exceeding 600 items), followed by file management deficiency (exceeding 500 items). Under fierce industrial competition, pharmaceutical enterprises face a challenge as to how to promote performance while controlling costs and simultaneously conforming to the rules and regulations of the supervising authorities.
This is exactly where NNIT has the advantage. As an IT consulting company derived from Novo Nordisk, NNIT has over 20 years’ experience in this field. With the support of project team professionals in verification of a computerized system, abundant IT consultants, adept in the pharmaceutical industry, and senior verification consultants, familiar with related FDA/CFDA/EMA rules and regulations, NNIT provides IT services for key fields such as drug research and development, industrial regulations, quality management, and electronic supervision and tracing. Sune Andersen, the General Manager of NNIT China, says: “NNIT is a rare enterprise dedicated to IT system consultation, development, technology management, and service, which is able to provide ISO certification and also meet its requirements. NNIT can develop and customize highly efficient solutions, according to the existing IT environment of the enterprise. NNIT optimizes business procedures, reduces the costs, and accelerates the time-to-market, as well as provides GxP-based IT schemes and services in full compliance with the requirements of the US’ s FDA, CFDA, and EMA. NNIT also knows the rules and regulations of other supervisory authorities to meet the key demands of the clients in the industry. ” Taking drug R&D as an example: The drug R&D process is complex, costly, and time-consuming, yet there is no shortcut option. Systematic process and compliance are of vital importance to the success of pharmaceutical enterprises. To achieve this, the enterprise needs a comprehensive IT strategy to support and optimize the whole clinical information supply chain, so that NNIT is able to offer a series of IT services ranging from eClinical analysis, CDMS, and CDW implementation; CDISC standardization to clinical cooperation platform; or even tracking and tracing the service and the success trail, thus facilitating the optimization of the drug R&D for pharmaceutical enterprises. As for contract outsourcing of the service organization of drug R&D (CRO), a contract research organization (CRO) needs highly efficient data acquisition and a clinical data management system to guarantee that the client can access high-quality data when necessary. Rundo International Pharmaceutical Research & Development Co., Ltd., the leading CRO in China, required a new system capable of processing Chinese and English and providing hard copy and electronic data. Therefore, NNIT developed a customized system, based on Oracle Clinical, remote data acquisition, and dictionary management system, and finished system installation and verification in six weeks. In this way, Rundo’ s pursuits of efficiency and compliance with CDISC standards were met.
NNIT has also offered multiple training and clinical practice solutions for CFDA, many hospitals, and CRO companies. It has also developed EDC/CTMS system quick-installation packages by considering CDISC or other relevant requirements, so as to meet the enterprise’ s need of data integrity.
All-round IT Service Provider
As the leading IT service provider in the industry, NNIT is capable of providing not only IT service for key fields, but also all-round IT service for enterprises covering IT strategy consultation, IT infrastructure planning and constructing, implementation of solutions, development of customized systems, 7×24 system operation maintenance, routine technical support, etc. In the past two decades, NNIT has provided IT consultation and service in different fields for most of the top 20 international pharmaceutical enterprises, including Novo Nordisk. In China, its service targets include Novo Nordisk, Lundbeck, Roche, Bayer, Takeda, Astellas, Tide, Luye, Tong Ren Tang, etc.
In 2004, Lundbeck headquarters, also located in Denmark, launched the “Fit for the Future” Project, aiming to promote the overall efficiency of the enterprise. The IT department became the top concern. For the IT department to promote efficiency is to reduce the operation & maintenance costs of the enterprise’ s applications, and to promote the operation and maintenance flexibility, expandability, and appropriate service level.
More Optimistic about the Development in the Future
NNIT has been providing service for domestic pharmaceutical enterprises since 2006. With a group of over 700 members in China, NNIT China is the largest branch other than Denmark, which provides services covering the whole business domain, including IT strategy consultation, solution development, system operation maintenance, routine technical support, etc.It is also the most important delivery center for European clients.
When talking about the China branch, Sune mentions that NNIT has been developing in China for ten years. This year, it ranked among the top 20 transnational service enterprises. The company not only focuses on life science and pharmaceutical enterprises, but it also makes full use of NNIT’ s rich experience in life science to extend products and services, such as application development, outsourcing, SAP solution, and IT infrastructure services out of the domain of life science. For instance, in 2016, NNIT signed a contract with WeEn, a joint venture semiconductor enterprise by NXP Semiconductors and Beijing Jianguang Asset Management Co., Ltd., to provide infrastructure, system transfer, routine operation and maintenance, and other IT services.
Sune is confident about the sustainable and rapid development of the pharmaceutical industry in China. It is of little consequence that China is the world’ s third-ranked pharmaceutical market or that “innovation and upgrading” are the key words of the “13th Five-Year Plan.” All these circumstances still provide a good opportunity for NNIT. NNIT has the confidence and capability to help more Chinese pharmaceutical enterprises to make full use of IT advantages, optimize drug R&D and production, and thus more actively meet the challenges in the international market.