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The traditional ‘best of breed’ approach to departmental systems in Life Sciences is losing popularity. That’s as a more comprehensive ‘platform’ approach enables greater flexibility, adaptability, and interoperability including data sharing. But change can feel onerous so it’s important to develop a strategy that’s both future proof and non-disruptive to your organization. fme’s professional services team can help you strike the right balance.
All organizations are striving to be more agile, productive, and cost-efficient, and none more so than those in the Life Sciences industry where the pressure to adapt and change is constant. And as long as individual business functions, such as Regulatory, Clinical, Quality, and Safety, continue to operate in silos using their own systems, data and document formats to fulfil their respective business processes, costs and complexity will increase rather than diminish.
Challenging the status quo can feel daunting, but Life Sciences organizations have limited choice about this. For many years, the ‘best of breed’ approach to deploying technology promised organizations optimal functionality as well as protection from single-vendor point of failure. But as data exchange and flow between teams and external parties (such as Regulatory agencies and outsourced partners) has grown in strategic importance, the pressing priorities now are platform and data standardization, simplification, and unification. A single, holistic platform approach is also ultimately easier and more cost-efficient to run and manage.
That’s not to say that any one software vendor has 100% of the functionality a Life Sciences company needs. The leading platform players, with a well-established end-to-end business capability, probably get close to ~90% while supporting the integration of peripheral elements such as submission publishing or specific IDMP components to provide full coverage.
This offers companies something to aim for, even if they do this incrementally via a phased approach.
Triggers for change: M&As, persistent pain points, new regulations
The best roadmaps for digital transformation allow for steady, manageable progress toward a simpler and more flexible future, while delivering (relatively) easy wins along the way.
There are many triggers that can initiate a technology change.
- A company merger inspires a more modern IT solution stack
- The incoming company in an acquisition has a mature business application platform and business process
- New industry regulations compel function-specific changes that are too onerous to apply
When these opportunities present themselves, the important thing is not to make another siloed decision, but to work toward a more modern, harmonized, and agile future state.
For instance, if Regulatory demands are becoming overwhelming, platform-based transformation could start here – applied initially to registrations (core data about licensed products), and archived submissions (aligned to that data). A next phase can then progress to content authoring, review, and approval process management.
Once Regulatory processes have been migrated to a modern cloud platform, companies can look to prepare Clinical, Quality, and Safety data and business processes for migration to the same core platform. Then each can access and add to the same core/master data set – enabling a unified platform.
One of the powerful benefits of tackling platform-based system modernization incrementally is that it presents the chance to bring people along on the journey. Teams have to opportunity to learn what works and what doesn’t, and refine features, processes, and capabilities along the way.
To ensure that any new system- and data-based decisions move the company in the right direction, and reap maximum returns, it’s important to be methodical in setting and following a strong overarching platform strategy.
We recommend:
- Establish the right mindset and gain leadership commitment and buy-in to a long-term platform-based technology and data management strategy.
- Start with a thorough ‘Phase 0’ assessment and gap analysis across the interlinked lines of business (Regulatory, Clinical, Quality, and Safety) to establish what’s possible and the level of work and investment that will be needed. This process could take 6+ months, depending on the size and complexity of the organization and its portfolio, and the current level of digital maturity.
- Bring in the right talent, both externally in terms of vendor and systems integrator/IT services support, and internally so that there are subject matter experts on the client side. These SMEs are essential to work with external providers to help confirm an appropriate roadmap and determine the investment in time and skills that will be needed on both sides to ensure success.
Benefits of a platform roadmap
A strategic platform roadmap will provide substantial guidance and benefits over time. With the support of an established modern, cloud-based platform, business functions will start to behave like well-oiled machines, optimized in their process management and ability to re-use the latest data on demand. Because cloud-based platforms are updated frequently, teams will be ahead of and less reactive to changes such as Regulatory updates as these continue to occur in the interests of patient safety and enhanced patient experiences.
The same goes for scope to add new functionality and incorporate the latest technology advances. A recent example is the emerging capability of AI solutions at they become more accessible, relevant to, and proven in Life Sciences processes.
Additionally, phased approach to modernization, as part of a longer-term single-platform strategy and roadmap, means that the business will encounter minimal disruption. There is an opportunity to socialize, mature and optimize new functionality so that it works well for everyone. Crucially, no new and costly legacy dead-ends will be created.
How fme can help
fme’s team of Life Science experts can support the entire end-to-end digital transformation experience. This starts with providing deep Life Sciences industry-specific business and IT deployment experience and best practice guidance to help shape the right long-term platform strategy via our Business Consulting team. We then provide full technical implementation, integration, and comprehensive migration services supported by a rich toolkit of solutions accelerators that are exclusive to fme.
We are a client-focused provider dedicated to your success. We partner with all of the major Life Sciences platform solution providers, so we are able to provide recommendations and services that meet the unique needs of your company with the most effective solution, and work in partnership with your own IT team.
Once the new platform is live, we also provide an intense ‘Hypercare’ package combining full business, technical and administrative support, as well as appropriate change management and training. Finally, we provide exceptional post-implementation managed services with fme PlatformAssist™ to maintain your environment through application updates, process improvement and daily support.
To learn more about our full range of services, and to discuss your specific requirements, contact us today. We’d love to help you establish your long-term roadmap to technology and business success.