The impact of the pandemic on RIM transformation plans

    At Amplexor's BE THE EXPERT, Steve Gens will reflect on companies’ progress with regulatory process transformation in light of COVID.

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    Steve Gens' session at Amplexor’s virtual BE THE EXPERT forum will take place on Tuesday, May 25th at 14:15 CEST. Entitled: Regulatory Impact of COVID-19: Shifting Priorities and Investments to get to RIM 2025, it will explore how regulatory organizations are adjusting their focus and investments in the near and longer term, following the impact of the pandemic, drawing on Gens & Associates COVID-19 Research conducted last September/October and its latest RIM 2025 projections.

    If the current pandemic had happened five years ago, the impact on life sciences regulatory activities would have been considerably more challenging than has proved the case over the last 12 months.

    This owes much to the work companies have done to connect and digitally transform their global regulatory information management environment. This modernization work has enabled them to adapt to the logistics of remote working and collaboration to keep pace with the demands of health authorities globally.

    Last September/October, my organization conducted special international research into the regulatory impact of COVID-19 from a process, system and organizational standpoint, and looking at which investments should be accelerated given the experience of the pandemic.

    We polled 183 individuals from 52 companies, together comprising a good cross-section of life sciences players by size and geography.

    In my BE THE EXPERT talk, I’ll be reviewing these findings in conjunction with our last set of projections of where companies expect to be with their RIM capabilities by 2025 - to determine how organizations are adjusting their investments in process and technology improvements, and what this is likely to mean for the short and medium term.

    How will it affect their end-to-end RIM ambitions, for instance, and what about their adoptions of unifying platforms and advanced tools including robotic process automation (RPA), artificial intelligence (AI) and natural language processing (NLP)?

    The continued need for speed

    To give a taste of what we’ve found, there has been – unsurprisingly – an acceleration of digitalization initiatives around the globe, from adoption of e-submissions standards to more dispersed processes for team collaboration on documents as workforces have disbanded. And the more standardized the information formats and global processes companies had in place prior to the pandemic, the better equipped teams have been to cope with more virtual ways of working.

    One of the more significant outcomes of the last 12 months has been the realization that decisions and transformative actions do not need to take as long as they have done traditionally.

    In crisis mode, all kinds of organizations have found that they can crunch timescales and deliver change at speed when it really matters. Over the last year we’ve seen departments switch collaborative work to Microsoft Teams in just three weeks, for instance - whereas previously that decision and shift might have taken many months.

    On average, we’ve seen project delivery timescales reduced by 80 per cent as those involved have focused on what needs to happen and just got on with the job. As first-hand evidence of this, Gens & Associates has been busier than ever during the pandemic, delivering quick-fire performance improvement workshops and helping companies pivot their focus, identify the root causes of data issues and set down milestone plans, or determine the best investment to deliver value, within just a couple of days.

    Companies learn a lot about themselves when faced with a crisis, and intense periods of short but extreme focus can yield breakthrough, actionable thinking.

    The challenge going forward will be how to maintain the ability to deliver high-quality outcomes at speed, as some degree of ‘normal’ resumes.

    I’ll delve into all of this during my session, and look at what this all means for companies continued RIM ambitions over the next four years.

    Published on    Last updated on 11/05/2021

    #Regulatory Information Management (RIM), #Life Sciences

    About the author

    Steve Gens is the managing partner of Gens and Associates, a global life sciences consulting firm specializing in strategic planning, RIM program development, industry benchmarking, and organizational performance.