Life sciences organizations are under pressure to change. They must adapt, become more dynamic in the way they operate, and they need a plan to do that.
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All life sciences organizations are under pressure to change. If the preventative healthcare and wellness trend doesn’t turn the industry upside down, it will be something else – from the need for more holistic remedies to the expectation of greater transparency.
Most of the challenges come down to companies’ response rates. To avoid falling behind competitively or getting into regulatory difficulty, life sciences firms must be able to react, predict, adapt and innovate at a rate and to a degree not previously imagined; they must also cooperate with partners, consumers and authorities in a range of new ways.
It’s a journey that mirrors those in other markets, from retail and financial services to healthcare: one involving digital transformation. As long as any business remains wedded to manual processes and information silos, its scope to respond and to innovate will be limited.
Myopia obscures other opportunities
One of the biggest issues life sciences organizations grapple with is information – and visibility across processes. Whatever data they are collecting, it is too often restricted by a given format and system, and confined to a particular department. These systems may enable certain actions to be taken, but they rarely provide a strategic benefit to the business. They don’t enable end-to-end visibility across product lifecycles, they don’t serve regulatory requirements around transparency and pharmacovigilance, nor do they inspire new thinking at a higher level in the business – for example by highlighting potential new business opportunities or threats to efficiency. There’s a lot of repetition too, as different teams collate overlapping data.
To go more boldly into the future, firms must think more broadly about how they capture, manage, share and use information. For many reasons it makes sense to take regulatory activities and systems as the starting point for wider digital transformation. It is here that a lot of important data companies already exists – and where a lot of work has to happen anyway for compliance purposes. The goal for organizations should be to try to achieve more from the same initiatives – by making sure these contribute towards new strategic business and market ambitions and plans.
Progress starts with certainty & clarity
The holy grail is a robust and comprehensive source of information – a single source of product ‘truth’ – that can be repurposed for all sorts of different uses across the business, whether in regulatory processes, or decision support in business development and marketing.
An important aim should be to harmonize existing and potential data sources – including document archives – so that all of the information locked within them is transformed into searchable, digital assets. Information must remain traceable back to its source, too: this means preserving links and enabling tracking information.
The efficiency gains should be multiple. Take the immediate challenge of regulatory submissions management. Applying for marketing authorization in an expanding number of regions and countries can tie up a lot of people’s time. If local affiliates are involved, this can add a further layer of complexity, and visibility may be hampered if supporting content can’t be readily accessed. If there is a reliable master data set, accessible digitally to authorized persons anywhere, the process becomes much more efficient and reliable. This also makes it easier for companies to test and enter new markets, without having to start from scratch in building up the information needed to satisfy local requirements. (The data doesn’t need to be physically centralized in a single location: consolidation can be achieved virtually, using connected repositories.)
Once there is a definitive, reliable master source of data, companies can start to think laterally about how they might leverage some of it in other ways too – for example to enable greater operational or business insights.
Every journey needs a destination – and a plan
Large-scale change requires a roadmap – it is not something that can happen all in one go – and this will vary based on where companies are now and what their strategic priorities are. It is vital that companies get started sooner rather than later though. There are no easy shortcuts, and the market is not going to wait. In 10 years’ time, the market may look very different again, so companies need to work towards a capability that will enable them to be ready for anything, rather than a fixed solution that meets the current set of challenges.
This is what the market leaders, and some of the smaller and more agile players, are working towards. Elsewhere, progress is labored: companies may be aware of the need to change but are often unsure where to begin. Perhaps they need help to map out their journey: if they do, there is plenty of external expertise available so this shouldn’t be a barrier.
They will need to begin by assessing where they are now, and where they need to get to; then acknowledging some of the broader, deeper changes that may be involved (from embracing a new mindset, to identifying where new skills will come from). At this point they will need to align systems and technical ability, to work towards that definitive operational or product ‘truth’ that will ultimately determine how an organization responds to new opportunities and demands.
The point is that, however they go about this, companies must embrace change – and to do that effectively they need a plan.
About the author
Elvis Paćelat is Vice President Compliance Management at AMPLEXOR Life Sciences. Elvis is a business and technology executive with more than two decades of international experience in the Life Sciences market. With detailed technical understanding and expertise in compliance and regulatory content management solutions for Life Sciences, Elvis is a specialist in business impact analysis. As AMPLEXOR’s VP Compliance Management, he is responsible for driving the corporate strategy and market success of the AMPLEXOR Life Sciences’ suite business. Elvis is committed to delivering benefit for clients, partners and shareholders, whilst supporting client-centric strategies and spearheading groundbreaking innovations.