We sat down with James Kelleher, CEO of Generis to understand…

Updated: Jul 5

  1. Going to Regulatory, Clinical, Quality or Safety to find the right person

  2. Finding the right documentation to provide an answer

  3. Creating and approving new content if it is needed

  4. Compiling and submitting the answer

  5. Checking that the same answer hasn’t already been submitted to a similar question in another submission to another agency etc.

From this example you can imagine similarly complex processes in other areas like Labeling or Safety once a drug or device is on the market. Everywhere, you find the same roadblocks preventing smooth information flow and reuse. In these cases it becomes critical for the content and data to exist just once, otherwise you end up with uncoordinated changes that trigger compliance problems.

Q: So logically, the best solution would be to put all of these processes and information into one system, because that way you have a single source of truth for both the data and the content?

Sounds good, right? Sadly, that doesn’t actually work. Here’s why:

  1. The processes involved, whether in RIM, Labeling, PV etc. are incredibly business-specific. Trying to get everyone to use the same UI and solution in order to achieve centralization is like equipping a 5-Star restaurant kitchen with 200 spoons; even if you can cut a carrot with a spoon, it’s going to be rubbish.

  2. The risk of moving to one single vendor is pretty obvious (migration, cost, single point of failure), and just because we’re talking about cloud-based monolithic solutions doesn’t make them new in any way – they still suffer exactly the same issues that we’ve been trying to escape for 20 years.

  3. This single solution doesn’t actually exist. While you’ve got some vendors out there claiming to be End-to-End, there isn’t a single one that has managed to achieve even 80% of just the RIM process to a high level of competence. That’s not even considering everything else aside from RIM. So all you’re doing there is creating yet another silo that is actually harder to integrate with, and generate cross-organisational information flow from, than a set of best of breed solutions.

Q: Where does that leave us? I need to centralise all my information, but I don’t want to create any more silos, I don’t want to compromise on the functionality that our business needs, and I don’t want to risk putting my eggs all in one basket with a single vendor.

That’s where Content Services comes in. Basically the Content Services approach is to say ‘we don’t care where this content and information is stored, we only care that we can access it everywhere that we need to.’

This has really only become possible in the past couple of years because of the trend towards increased, more comprehensive APIs. These days if you’re not building your software to be maximise integration possibilities, you’re going to be out of the market within two or three years. Even ‘best of breed’ software vendors with 10 years’ experience are struggling now because they’re just point-solutions that can’t integrate. So really, when we talk about best of breed now, that has to include seamless integration abilities, with guarantees covering upgrades.

The idea of Content Services is to bring these new best of breed solutions together, and create a seamless landscape, where the user has access to all the content and information they need without leaving the interface they’re working in, and the business can generate reports and insight across their entire organisation.

Q: So what is CARA and how does it bring this new landscape together?

CARA is our Intelligent Content Services Platform. It’s really a framework for information management solutions that you can configure to an amazing extent to suit your business processes. With CARA you can pick and choose from our extensive OOTB solutions for Life Sciences, and seamlessly integrate with the other systems that you already have and like.

We basically say, ‘You know that publishing system you love? Keep it – there is no need to replace it; we’ll just integrate deeply with it. You don’t like your SOP/Quality system? Fine – we can replace it with CARA.’

CARA can connect to these new best of breed solutions in order to push, pull, and display relevant information live, but most significantly CARA can also connect to multiple repositories at once. This means you can have content stored anywhere (the user doesn’t care where, after all) and get full, instant access.

The result is that we can finally provide the user with access to all their relevant content and data, without sacrificing on functionality, without constant large migrations, and without signing away our futures to one vendor at extreme cost.