Key Life Sciences regulatory and associated operational processes are becoming increasingly data driven, requiring integration and reliable data exchange across multiple business functions and applications. Whether you’re migrating to a new RIM system, or looking to connect with manufacturing/SAP or other systems, our deeply experienced team has all of the technical and sector-specific knowledge to deliver end-to-end solutions.

 

An extension of your IT team: whenever you need our specialist expertise

Whether you’re a sizeable pharma organization, or a more modest biotech or medical device company, it’s likely that your IT ambitions have grown over recent months. That might be due to a regulatory information system (RIM) implementation or upgrade, or a drive to make data work harder for the wider enterprise.

Certainly, we are seeing updated regulations (such as IDMP and MDR), and a growing emphasis on data generally, translating into more advanced digital transformation initiatives. In many cases, these next-level projects will encompass more than one departmental function and set of integrated IT systems. That’s to ensure that data is unified and consistent right across the organization and its regulatory touch points.

The good news is that fme’s extensive, highly skilled, and deeply experienced Life Sciences technical team is on hand to help.

Our 360-degree perspective is unique

We’re unique in our ability to combine detailed knowledge of all of the major technology platforms with extensive knowledge of digital transformation best practice across Life Sciences.

Deep cross-platform expertise

We’re deeply skilled in integrating, migrating, and enabling the reliable exchange of data across all of the major platforms used in Life Sciences. These range from Veeva, Sparta, Generis CARA, Documentum, Hyland, and Alfresco, to all of the popular manufacturing information systems, accounting/resource management systems (like SAP), chemical systems, health & safety systems, and more.

Across any combination of these platforms, we can help with all of the following:

• Strategic project planning/roadmapping
• Application integration
• Data transformation/conversion & migration
• Data integration
• Data validation
• Experience in complex regulated industries

Even more importantly, we have an unparalleled understanding of the opportunities for amplifying the ROI of complex systems as well as the technical challenges and regulations facing the Life Sciences industry today. This combination of skills gives us a unique perspective for helping companies across the sector realize the benefits of technology efficiently and effectively.

In addition to our in-depth knowledge of the the critical success factors of data-driven transformation in the pharma, biotech and medical device sectors, we also bring to bear best practices from other global industries that face similar strict regulations, yet are more advanced in their IT-based solutions. fme manages and supports technical projects across the automotive, chemical, energy, and food industries, supporting and guiding these clients throughout their strategic technical plans and in the practicalities of their integration and data migration initiatives. The rich experience in these additional diverse challenges has allowed us to distill and refine the most effective methodologies to apply strategically in more effective solutions for our Life Sciences clients.

End-to-end services

As an optimally-sized firm, fme has the agility to deliver services from small to large scale. Our global presence is perfectly positioned to provide best-shore teams from our locations across the US, Europe, and India. Sometimes, our clients only need an additional specialist to supplement their own internal IT resources. As they take on new and ambitious system upgrades, consolidations or fuller digital transformation projects, fme efficiently scales resources to match their increasing requirements. This unique technology partnership capability allows us to provide end-to-end services that match our clients’ needs.

Business Consulting
If you’re not sure where to start, or are having trouble translating data ambitions into tangible projects and timelines, we can definitely help. This includes building the business case for projects that are often overlooked and difficult to coordinate cross-departmental justification and budgets.

Technology, data, and migration services
As well as becoming more efficient and data driven, most companies are looking to streamline their complex IT estates with the goal of bringing down the total cost of ownership, reduce duplication of effort, and increasing confidence in data as a dependable source of enterprise and regulatory intelligence. The Holy Grail of most data-related projects today is to create a single, connected source of truth: entering data once, and utilizing accurately across all use cases. fme has unparalleled experience in each of these areas, connecting business processes, data and documents in an integrated solution aligned with business goals.

We can also serve as strategic project managers, implementation partners, or at a much earlier stage as consultants and project designers. Our technical subject matter experts can fill specific gaps in capability, or we can do it all – all the while bringing industry and parallel sector experience to bear to maximize project success.

Managed services
We can also support you across and beyond a digital transformation or system integration/consolidation/upgrade project, ensuring the data is and remains as it should be – correct, up to date, high quality, and trustworthy.

Your partner for digital transformation

Our goal for each of clients is to provide the most effective services and support required to support their strategic and technical business goals. We are your partner in waiting for any aspect of:

• Business consulting
• Technology services
• Migration services
• Managed services

Wherever your needs fall across this spectrum, we’d love to discuss how we can help.

Contact us today
For more information, please complete the contact form by clicking on the button below and we’ll schedule a time to discuss how we can help you eliminate your challenges, increase your IT ROI, and decrease your system TCO.

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About the Author

Ian Crone became the Business Unit Director for the fme Life Sciences Team in Europe in October 2021. He has a background in Chemical Engineering, which is the subject of both his degree at Strathclyde University in Scotland and the first fourteen years of his career at Unilever. Over the two decades since, prior to joining fme, Ian has been involved in the Chemical and Pharmaceutical industry, from every angle of drug development, specialising in NMR, IDMP, RIM, medical devices and regulatory solutions for some of the largest Life Sciences and Pharmaceutical companies around the globe. He has been involved both from an industry and technology supply side, in roles held at Oxford Instruments, BioStorage Technologies, Samarind and Amplexor. Ian enjoyed living and working internationally during his consulting career and brings more than 20 years of experience in the Life Sciences industry to his new role at fme.

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