The facts Employees: Over 1600 and growing Annual turnover: 造222 million Headquarters: Copenhagen, Denmark Offices: Denmark, Switzerland, Czech Republic, China and the Philippines Founded: 1994
Call in the specialists
At NNIT we are dedicated to using IT to overcome the com足plex challenges inherent in the life sciences industry. From meeting the overall objective of shortening the time it takes to get products to market to the more down-to-earth practicalities of cost reduction and IT process optimisation, we understand what you are up against. And we have the IT solutions you need. As a full-service IT provider, our people come from a range of backgrounds and include both big picture strategy experts and hands-on professional practitioners. Together we turn strategic IT into optimal operational solutions. In other words, we put good practice into practice.
3
Why make it more difficult?
NNIT is an independent IT provider. We have established partnerships with all the main technology suppliers, such as SAP, Microsoft, Oracle, EMC, Cisco and HP, so we know the different advantages and benefits they can bring to your business. And also where any pitfalls lie. This experience combined with our in-depth industry knowledge means we can give you straight talking advice on all strategic levels so you get the right system or solution for your organisation. Because ultimately the best IT solutions are the ones that meet your needs, not ours.
4
I look at the FACT (Clinical Data Warehouse) project as an extremely well-planned and well-conducted IT project. It was delivered within timelines and within budget, which I as the sponsor am very grateful for. Dr Sรถren Kristiansen, Head of Data Science, Nycomed GmbH
The bigger picture with all the details As a full-service IT provider, we are able to see the full picture of how IT can be used to support and optimise your business processes across the entire pharmaceutical chain. We have an insiders’ understanding of how the industry works and ensure all of our services or solutions are based on industry best practice and fully compliant with applicable regulatory demands, including FDA and EMA regulations.
Drug Development
Drug Research
Trial Execution
Analysis & Reporting
• Discovery
• Trial design and planning
• Statistical analysis
• Preclinical
• Trial registration
• Submission
• Patents
• Trial management and monitoring
• Drug formulation & CMC
• Trial supply • Data management • Safety
Pharmacovigilance Regulatory & Quality Management
Integrated Drug Regulatory Affairs The burden of regulation imposed by national health system legi- slation and regulatory authorities places a growing strain on many businesses. We help you use IT to comply with new and upcoming regulations on drug development, approval and marketing while improving collaboration across your organisation.
6
Strategic Planning • Supply chain management • Contract manufacturing • Strategic purchasing • Demand forecasting
Integrated Drug Development Transforming a compound into a drug is a massive investment. An integrated IT strategy for your complete clinical information supply chain can maximise this investment and speed up time to market. Integrated Pharmaceutical Production Ensuring continuous productivity improvement gains and managing increased complexity in your product portfolio requires efficient IT support. We offer a range of services and solutions, including Production Management Systems (ERP), Quality Management and Application Management Services, to help you maintain the highest levels of quality, stability and compliance. Integrated Pharmaceutical Marketing When converting R&D efforts and investments into marketing strategies, launches and campaigns, you need easy access to all your data and systems. We offer a CRM solution for life sciences, based on Microsoft’s well-proven technology, that integrates your data into a structured model and provides you with the most up-to-date intelligence.
Pharmaceutical Production
Pharmaceutical Marketing
Manufacturing & Supply Chain
Quality Control
Marketing & Sales
• Production and capacity planning
• Batch releasing
• Strategy development
• Stock and logistics
• Laboratory integration
• Sales force management
• Purchasing
• Traceability
• Medical/marketing management
• Plant maintenance
• Environmental monitoring
• External affairs management
• Production
• Post-marketing studies
• Performance reporting
• CRM
Integrated Quality Management Our specialist teams help you improve, integrate and validate your quality management processes. Using tools such as HP Quality Center, either as a standard set-up or delivered as SaaS, we ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.
7
Their challenge required an IT group with resources and expertise, and they recognised NNIT as a leading FirstDoc expert. They knew that we could deliver and provide the skilled resources they needed to best support their in-house IT department. Dieter Schlaps, Director Integrated Drug Regulatory Affairs, NNIT Switzerland
Compliance – a licence to operate
Regulatory authorities set the rules for IT compliance in the GxP environment of the pharmaceutical industry. We appreciate that following these rules is a pre-requisite for doing business and work with compliance at all levels – from the theoretical framework to the necessary ‘paperwork’ and implementation of GxP solutions. We have been helping businesses in the life sciences industry with all aspects of validation of IT processes since 1994. Our business processes are regularly audited by accredited pharmaceutical companies and our GxP compliance Quality Management System has been ISO 9001 certified since 1997. With this kind of accreditation behind us, you can have the peace of mind you need to concentrate on developing your business.
9
From outsourcing to right-sourcing
Virtualisation and Cloud technology have brought new opportunities for the flexible use of technologies and IT delivery models. However, before you can pinpoint the right strategy, you need to consider factors such as data security and the physical location of valuable data, as well as practicalities such as updates and handling of any incidents. We offer a complete service that allows you to strategically combine offshoring, near-shoring, traditional operations and the benefits of our GxP Cloud. By finding the right combination, you gain a significant competitive advantage without compromising on your need for customisation, complex integrations, service and support. That’s what we mean by right-sourcing.
10
I guess it has reduced testing time by anything from 30 to 50 percent. It’s also made documentation to authorities much simpler and faster. Mikael May Yde, Head of IT Compliance in Corporate IT, H. Lundbeck A/S
What they were looking for was a reliable partner to implement and maintain a corporate-wide system for managing regulated documents. A system like this is critical for our customer. They needed a sophisticated platform and that requires sophisticated support. That’s why they chose NNIT. Johann Gautier, Director Life Sciences Consulting, NNIT
Full service from A to S
We are a full service IT provider with services that cover the full ‘advise to support’ life cycle of an IT project. From high level IT strategy development to making sure your systems are delivering the results you need, we work closely with your organisation to help you use IT to overcome your business challenges. Our solutions are based on standard software and tech nology from all the leading technology providers and customised to meet your exact needs. However, if necessary our team can also design a tailor-made solution for your individual business. Our services fall into four main categories: Advise: Consultancy, analysis and guidance for the strategic application of IT. Build: Development and implementation of both standard and tailor-made solutions. Operate: Hosting, maintenance and Application Management Services that ensure high-performing, future-proof IT infrastructure. Support: Dedicated and flexible support that keeps systems running with maximum uptime.
13
We eat, sleep and breathe IT so you don’t have to
NNIT started life as the IT department of an international pharmaceutical company. This has given us an insiders’ understanding of the way the life sciences industry works. And the specialist knowledge necessary to help you get more from your IT systems. Our people are united by a high level of IT expertise coupled with a commitment to deliver the highest level of quality. In short, we go out of our way to make sure your IT processes increase your business efficiency and support your organisational ambitions.
14
One Friday night, we realised we needed help. In no time, NNIT assembled a team to help us out. And we didn’t need to talk about contractual conditions first. All the talk was about how to get the job done. Michael Vasa Skånstrøm, IT Director, H. Lundbeck A/S
nnit 1011
NNIT A/S Lottenborgvej 24 DK-2800 Lyngby tel: +45 4442 4242 NNIT Switzerland Bandliweg 20 CH-8048 Zurich tel: +41 44 405 9090 NNIT Czech Republic Dobrovskèho 397/8 CZ-77900 Olomouc tel: +420 585 204 821 NNIT China 358 Nanjing Rd. CN-Tianjin 300100 tel: +86 (22) 58 856 666 NNIT 16 Philippines 24/F 88 Corporate Center 141 Valero St. Makati City 1227 tel: +63 2 889 0999