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WHITE PAPERS

10 tips for selecting the best Commercial Off The Shelf (COTS) software product

CRM for Life Sciences

Go Digital or Die

How to Design a Clinical Data Warehouse

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PRODUCTS & SERVICES

Drug Development

Enjoy An Agile, Scalable And Cost-Effective Infrastructure

Full-Service IT Provider

GxP Infrastructure Outsourcing

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LATEST PRESS RELEASES

November 11, 2014

NNIT in the Press

NNIT has more than 2,300 employees - more than 700 employees work outside the borders of Denmark – in China,...

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NNIT

NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry.

NNIT has more than 20 years of industry experience and an insider’s understanding of how the industry works and ensure all of our services or solutions are based on industry best practice and fully compliant with FDA, EMA and demands from other regulators.

NNIT NNIT Services
Drug Development
Regulatory Affairs
Quality management
Track & Trace/ Serialisation
GxP infrastructure outsourcing

To get to know us better, visit us at www.nnit.com, download our app myNNIT or sign up for our life sciences newsletter.

Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You’ll get articles, whitepapers, cases and invitations to webinars. Sign up here.

NNIT Headquarters
NNIT A/S
Østmarken 3A
DK-2860 Søborg
Tel: +45 7024 4242
Fax: +45 4437 1001
CVR-nr.: 21093106

Contact NNIT here.

Drug Development

Transforming a compound into a drug is a massive investment. An integrated IT strategy across your clinical value chain can maximise this investment and speed up time to market.

eClinicalTrial master fileDrug safetyClinical data warehouseCDISCElectonic data capture/CDMS

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Enjoy An Agile, Scalable And Cost-Effective Infrastructure

With NNIT’s GxP Cloud you get all the benefits of traditional cloud computing, such as scalability, elasticity, availability and pay per use – but with the security, compliance and full data control your business requires. Your business-critical data and applications are stored in an environment that is secure and constantly ready for regulatory inspection. Furthermore, as it is located in Denmark, in the EU, the GxP Cloud is fully compliant with all EU legislation.

Save up to 80% of validation costsWith the GxP Cloud compliance is achieved through prequali-fied processes and components and automation. This can lead to savings of up to 80% of the costs associated with carrying out validation processes. More importantly, the GxP Cloud reduces time to market as services can be ready within a day.…

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Full-Service IT Provider

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 process 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.

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GxP Infrastructure Outsourcing

Infrastructure complexity is increasing and life sciences companies are under a constant pressure to cut costs. Outsourcing is a lever for cutting costs and freeing up internal resources for tasks other than daily operations. NNIT deliver integrated infrastructure outsourcing and application outsourcing that can improve your business processes to reduce costs, free up resources, minimise risk and shorten time to market.

GxP cloudOutsourcing of GxP applicationsLife sciences applicationsTo get to know us better, visit us at nnit.com, download our app myNNIT or sign up for our life sciences newsletter.

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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.

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Integrated Drug Regulatory Affairs

The bureaucratic burden of regulation imposed by national health system legislation 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.

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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.

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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.

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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.

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Products and Services

Product Licensing & Distribution Opportunities

Product Licensing & Distribution OpportunitiesAptalis Pharmaceutical Technologies has a number of Rx and OTC products available for licensing. In general, these products are new formulations of existing drugs that incorporate one or more of our proprietary drug delivery technologies. We license these products to pharmaceutical companies for marketing throughout the world.Currently more than 40 products…

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Quality Management

Effective quality management processes in the life science industry are critical to meet the intense regulatory requirements.NNIT can ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.

Lean validationQuality management outsourcingTest and requirements management

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Regulatory Affairs

psn offers a wide range of services in connection with registration of human and veterinary pharmaceuticals, medical devices and biotech products from a full registration package or customized deliverable to translation of a simple text into local languages.Local presence and experience give psn a clear advantage in assisting its clients with their regulatory needs. Submission…

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Serialisation

Millions of people die every year due to erroneous treatment with counterfeit drugs. To break the cycle with counterfeit drugs, authorities in most major markets are putting regulations into place to enhance patient’s safety. NNIT and NNE Pharmaplan offer a full end-to-end Track and Trace programme covering all aspects of serialisation, from packaging to the point of dispense. Learn more about NNIT and find out how you comply with the serialisation requirements.

Track and Trace

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Sign up to NNIT’s Newsletter

Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You'll get articles, whitepapers, cases and invitations to webinars. Sign up here: http://www.nnit.com/pages/news.aspx/

DOWNLOAD WHITEPAPER

How to Design a Clinical Data Warehouse

The Source Data Mapping (SDM) module includes one mapping design (ETL) for each source from which the CDW is loading, thereby replacing several of the 'foundation' CDW features described above. How static or dynamic the ETL needs to be depends on the level of flexibility and variation in the data source. If data are sourced from a Clinical Data Management (CDM) system, there will be variations in how the trials are defined and structured. In this case, one should consider making the source data mapping dynamic and letting the SDM handle any necessary data conversion.

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Go Digital or Die

What is the raison d'être for pharmaceutical companies? An ethical one would be that pharmaceutical companies must develop innovative products that make a difference for people. An improvement at even the smallest margins potentially translates into prolonged life or improved quality of life. So we measure at more and more delicate margins - hoping to discover the one magical compound in the alchemist's kitchen that has the potential to make a difference - and to become a blockbuster. Because, let's be honest: regardless of the noble work we are not in philanthropy. It's also tough business. Every day preceding the launch of a new drug is an investment. Eventually shareholders crave value for money.

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CRM for Life Sciences

The pharmaceutical market is undergoing radical change and companies are forced to restructure their commercial organisations to face the new market needs and new business models. Increasing market restrictions and new stakeholders representing a change of decision power are some of the challenges.

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10 tips for selecting the best Commercial Off The Shelf (COTS) software product

Selecting a Commercial Off The Shelf (COTS) software product is usually a demanding process. Not only does it require clear objectives and goals, but also a dedicated group of key stakeholders with substantial business process insight. Moreover, to ensure the process is successfully planned and completed, it's necessary to use a transparent method to document decisions and capture learnings and decisions.

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Top Products from NNIT

Transforming a compound into a drug is a massive investment. An integrated IT strategy across your clinical value chain can maximise this investment and speed up time to market.

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 process across the entire pharmaceutical chain.

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.

Product Licensing & Distribution Opportunities

Effective quality management processes in the life science industry are critical to meet the intense regulatory requirements.NNIT can ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.

Sign up to NNIT’s Newsletter

Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You'll get articles, whitepapers, cases and invitations to webinars. Sign up here: http://www.nnit.com/pages/news.aspx/

How to Design a Clinical Data Warehouse

Go Digital or Die

CRM for Life Sciences

The pharmaceutical market is undergoing radical change and companies are forced to restructure their commercial organisations to face the new market needs and new business models. Increasing market restrictions and new stakeholders representing a change of decision power are some of the challenges.

10 tips for selecting the best Commercial Off The Shelf (COTS) software product

Contact NNIT

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