Aligning Clinical And Regulatory Functions - Part 1

Aligning Clinical and Regulatory Functions

– Part 1

In a perfect world, life science companies would have access to technologies that optimize the way people work in the digital age. Systems would be intuitive, and enable collaboration and easy access to data and actionable insights, while maintaining compliance and control.

This isn’t the world we live in. For most companies, technological systems were assembled one application at a time, from different vendors, to solve specific and disparate problems. As a result, integrations are hard-coded, and collaboration is difficult. User experience is not consistent, and confidence in data accuracy is limited because the data lives in multiple systems, siloed, fragmented, and inefficient.

In today’s reality of high-speed innovation, this outmoded system of technological development isn’t an option any longer. The pressure to accelerate cycle times, while reducing costs, continues to intensify. Over the past decade, as complexity increased alongside regulation, the average drug development time has grown by nearly 25%, reducing the available time to recoup costs before patent expiration.

The truth is that, despite the strides most life science companies have made to automate and eliminate paper-based processes, they face a major obstacle in the inefficiencies existing across different processes. This is especially problematic when these processes span multiple product lines and many countries globally, and is compounded by an existing jumble of legacy systems and data sources. Because of this, coordinating and managing information absorbs an inordinate amount of unproductive time.



It goes without saying that companies must find ways to eliminate waste in business processes and improve how information is managed. And as the industry gradually shifts from data collection to risk prevention and mitigation, from silos of activity to consumer and payer centricity, from reaction to proactivity, the focus must be on implementing and optimizing digital technologies. In tandem, the most forward-looking companies are reimagining their fundamental organizational structures, and considering a digital transformation that supports the complete drug development lifecycle.

Rethinking the organization is necessary because, traditionally, there has been a major disconnect between the clinical and regulatory disciplines. This can likely be attributed to the processes of a paper world, where information was passed down the workflow only when reports and data analysis were complete. Yet in fact, the drug development lifecycle starts at molecule discovery, extends through human trials to commercialization, and eventually, removal from market. While the activities of the research phase might be much different from the commercialization phase, the two are co-dependent. There are enormous efficiencies and increasing transparency to be gained by closer collaboration between these groups when they view the complete lifecycle as a single shared purpose.

Now, digital transformation makes it possible for your entire company – and its partners – to work with a single source of truth for data that is extended throughout the lifecycle. By moving steadily toward digitalization and a new generation of unified, integrated solutions, regulatory and clinical organizations can evolve to truly take advantage of the changes occurring in the industry.

It is important to keep in mind, too, that these seismic changes include the steady escalation of mergers and acquisitions – primarily large enterprises acquiring promising startups and R&D laboratories. This spells an essential strategic shift when it comes to managing intellectual property: to simplify transfer of assets after acquisition, which requires a very different approach to managing content when moving from concept to development.

Doug Burgener

Regulatory & Clinical Solutions

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