Reflections on regulatory information management in 2020

2020 reflections on regulatory information management

What has COVID-19 revealed in the way of regulatory information management (RIM) related shortcomings, and to what extent should pharmaceutical companies step up their digital transformation plans for 2021 to avoid sustaining these challenges?

If life sciences organisations had been more purposeful about achieving unified global RIM, they might have fared better in managing regulatory activities remotely as entrenched practices were challenged in 2020. Ordinarily, regulatory team members might turn to their neighbour for the answers needed to complete documentation, build submissions, or address health authorities’ questions. But as the world went into lockdown and teams dispersed to work from home, fact-finding became a much taller order.

Ironically, this came at a time when pharmaceutical companies needed to be at their most efficient and agile: able to adapt sources of supply; switch facilities; ramp up volumes of in-demand drugs; and accelerate speed to market with new or newly sought-after products. Painkillers, ’flu remedies, anti-depressants – all experienced a surge in sales and prescriptions as populations tried to cope with not just the physical health risks but also the mental load of such dramatic changes to daily life.

The renewed case for unified RIM

Systemic, unified regulatory information management based on pooled, authoritative master data could have helped enormously with all of the change thrust upon life sciences – enabling companies to track and get ahead of emerging situations and opportunities and their responses to them.

Surprisingly, though, many IT projects already given the green light – and assigned budget – stalled in 2020. RIM replacement strategies gave way to patchworks of tactical measures. Instead of striking now, to obviate the pain of disjointed systems, poor information access, and the immense manual tasks of finding, combining and preparing information for reporting or analysis, regulatory operations just gritted their teeth and carried on. And yet, if they had pressed on with projects as originally scheduled, they might have been in completely new territory by now – benefiting from industry best practice, using a largely out-of-the-box solution implemented and delivered via the cloud, entirely remotely.

Intensified points of pain

It is difficult to imagine how global life sciences organisations wouldn’t have come unstuck during 2020 where they have lacked unified, coordinated RIM. Old methods of manual data conversion, of Excel-based data analysis, and of trying to keep track of submission schedules – not to mention processing and seeking approval for all of the changes triggered by disruption to global markets and supply chains – must have presented considerable risk, as well as challenges to productivity and speed to market. This will have been true especially as teams fragmented physically, forced to take their work home with them.

Failure to keep RIM transformation projects moving will have had an impact – precluding easy wins linked to having assured access to the latest submitted content and regulatory status information, and the means of collaborating on document authoring and content review in parallel rather than sequentially.

Bridging distance

Everyone is working differently now – with no sign of an end to the current disruption. Teams must continue to connect remotely, following the sun, and cooperating more closely than ever with distant affiliates to address supply issues and changes to product demand. If alternative sources of raw materials or manufacturing capacity become necessary, companies need a way to manage all of this from a quality/safety and marketing approval perspective.

In situations like these, unified global RIM platform would keep everyone in the loop, effortlessly. Meanwhile change requests and alerts to emerging issues could be issued automatically, triggering early action. Disruption to team members’ locations, meanwhile, would prove no barrier to progressing work, particularly with a cloud-based global RIM platform. In fact, with a web-based solution, the IT implementation – even the business change management and team workshops – could be managed entirely remotely.

Remote working is likely to remain the norm now. Collaborative authoring, already mentioned, is just one of the advanced ways remote teams can boost their output to cope with this. When all of the information is readily accessible as a ‘corporate knowledge asset’, and team members can work on it in parallel, this drives much faster task completion (eg submission planning and building). That’s compared to traditional methods of circulating PDFs or individual spreadsheets for feedback, with the author painstakingly absorbing all requested changes.

Spotting opportunities ahead of time

The other crucial benefit to a more coordinated approach to RIM is the opportunity to gain a 360-degree perspective of regulatory activity and product/market status globally. The ability to spot untapped market opportunities, or potential red flags as licenses come up for renewal or safety updates are due, is almost impossible to quantify – but it is significant.

Whether companies are bringing to market novel COVID-19 therapies or potential vaccines, or have useful ancillary products such as analgesics or anti-depressants, a unified global RIM platform would help identify and highlight markets where demand is particularly strong, or where products are not currently being sold – so that the teams responsible can target resources appropriately and accelerate marketing approvals.

Certainly, there is no time like the present for pharmaceutical companies to get their global operations in order. The information management challenges that existed before COVID-19 haven’t gone away; rather they have been magnified. To maximize market opportunities, companies need to be able to navigate and manage change in ever more effective and efficient ways – and unified global RIM offers the best means to do this.