In June I will be swapping my busy schedule of client CARA Life Science implementations for an equally hectic and rewarding life attempting to tame my 2 acres of rural idyll in Denbigh, Wales. By then I will have given the industry 22 years and spent 6 enormously fulfilling and inspirational years at Generis, a time that has borne witness to a phenomenal degree of change as technology has advanced – and, with it, clients’ ambitions to transform the way they work.
Here are some takeaways which are arguably even more relevant to the journeys companies are navigating now.
1. Change can’t be avoided: break out of your comfort zone.
In 2000, hardly the dark ages but still more than 2 decades ago, the web still felt mysterious and new. Regulatory teams were starting to get into replacing paperwork with electronic document management systems (EDMSs), but were already coming up against many of the barriers still perceived today – such as, What if I can’t find the content I need when it’s urgent?
Today, filing and searching are much more intuitive so that systems don’t need to be over-engineered for every eventuality – especially if you choose a cloud-based platform which supports multiple use cases, all drawing on the same reliable data and content ‘lake’. Best of all, these assets (which don’t have to be structured in a particular way to be found) can be called up on demand - and in context – as part of the given business process.
2. Everyone needs to do their bit to deliver data standards.
A bright new data-driven world is on the horizon now, which will ultimately reduce reliance on static PDFs. In the future, regulatory submissions and other activities such as reporting will be managed through a simple case of data submission, with minimal surrounding text needed to provide the context.
The challenge though is achieving standardisation. In Europe, DADI, SPOR/IDMP/TOM and FHIR are all part of the emerging solution, but at this point questions still remain about how all of this will come together, especially on a global scale. Today, the industry is juggling multiple projects to prepare for all of this, which collectively is costing billions.
Progress will depend on regulators being more decisive and proactive, and on all stakeholders (including industry and software vendors) playing a part in cementing decisions and, in the context of FHIR, getting at least the main communications specs up and running. Activities like the HL7 FHIR ‘Connectathons’ – in which developers, programmers, technology experts, analysts, and content management experts come together to learn about emerging APIs and HL7 FHIR Implementation, with a chance for hands-on FHIR development and testing - are an encouraging move in the right direction. While having agreed standards in place is very important, the real challenge we all need to address is getting these in place and usable.
3. Excellence takes continuous effort.
I’ve been extremely lucky to be a member of some exceptional teams during my career - both client-side and internally. Here at Generis, a really outstanding team is the one working on the next-generation CARA platform (CARA 5) which supports a whole range of Life Sciences processes from RIM and IDMP and SPOR compliance, to Quality, Safety and Clinical Trial Management.
There’s a deep understanding at the highest level of this important and fast-growing company, of the importance of letting creative people create, and it really sets Generis apart.
Too often, software companies feel they have arrived at success with a product that people love, but then they don’t continue to adapt it. Their product stagnates, and in the meantime someone more agile delivers the new flexibility customers crave. Generis retains a refreshing humility here. The team assumes nothing but rather keeps listening to customers, so that it can keep its offerings relevant and future-proof.
Building everything on one flexible, foundational cloud-based platform means Generis can keep innovating too, without disrupting everything that works well for customers today. Crucially, the company seeks feedback from across its client connections – not just from techies.
The ability to integrate, view and track RIM content and activity globally is just one of the many capabilities developed in response to client requests. That same approach is now extended right across the CARA platform, enabling users to find, access and manage data and content seamlessly across different departments and processes, all in context (ie ‘Bring up everything I need to do X’), underpinned by the same unified platform.
4. Usability matters more than people realise.
Finally, the most magnificent technology system will not succeed if people can’t figure out what to do without two weeks of training each year. It’s so easy to lose sight of this, but Generis has a strong focus on intuitive usability. In fact, it’s often the enthusiastic adoption of CARA in one part of an organisation that inspires additional use cases as word spreads about how seamless and easy our software is to use - and long may this continue.