Buckle up – 2022 is going to be a heck of a year for regulatory process reinvention in Life Sciences


It’s with a great sense of promise and excitement that I have begun my new role with Generis as Head of Life Sciences. It’s very clear that this company’s ambition is to expand quickly, and to continue to develop the scope of the CARA™ Life Science platform at a pace as the market continues to transform, and as new opportunities emerge to manage regulated data and documents in smarter ways.

The opportunities for process transformation in Life Sciences are considerable. Generis is operating at the cutting edge of technology, with robust capabilities for the management of data and structured content, IDMP and RIM processes, making this a very timely point for me to be joining the company. With a background in Regulatory and Quality content and data management, I can see the enormous potential of structured content authoring and management to transform the way companies tackle data management initiatives like IDMP.

As IDMP is rolled out in Europe and DADI (digital application dataset integration) takes over from electronic application forms as a first major step in IDMP implementation, the need for pharma companies to manage their information in new ways will become increasingly apparent. With a much clearer scope and timeline for the DADI go-live, the time to act is now.


The transformative power of data: Generis gets it in a way its competitors don’t

I’ve been watching Generis with great interest over the last year. I was drawn in by the company’s captivating online demos, and the wide array of new functionality they’ve been announcing.

The fact that Generis has a deep understanding of the interrelationship and potential for greater and more seamless interplay of data and documents really sets the company apart. This will act as a springboard for Regulatory transformation – and beyond.

CARA’s single platform approach for development and integration of different functionalities, drawing on the same live data and document repository, is immensely powerful – and something other vendors might aspire to but certainly don’t offer today. That’s despite the fact that this is very clearly where the regulators are heading, and where any meaningful transformation of regulated information management and publishing/exchange processes must follow.

Whereas in the past the emphasis was primarily on documents as the main source of published truth, now access to live data is becoming increasingly important. The role of documents won’t go away, but documents and their underlying data will become much more closely linked in the future. This will pave the way for automated document creation/data extraction, removing the risk of error, duplication/redundancy and gaps in information.

As IDMP becomes a reality in Europe, and as other similar initiatives take hold globally, I am convinced that a smarter, data-driven approach to regulated information and content management is the way forward.

As I talk to people across Generis, I’m in no doubt about the company’s vision and accelerating growth rate, and I’m looking forward to playing an active role in delivering against all of this exciting potential.

I’m really delighted to be here, and can’t wait to roll up my sleeves and get stuck in.