I owe an apology for mangling his art to Richard S. Castellano, who improvised the famous line from the movie The Godfather. But I wanted to have a bold statement in the title about the fact that software platforms, those expensive unwieldy monoliths on which we have been erecting three generations of life sciences software, are done. Fini. Kaput. Or as they would say in The Godfather, they’re dead to me.
Why the Platform Is No Longer Required
The software used over several technology generations for managing TMF content, SOPs, and Quality processes evolved from the original release of the major document management platforms in the 1990s: OpenText and Documentum in particular. Companies built or bought modular solutions built on top of those platforms, and that model — applications built on Document Management platforms — has persisted through the age of SharePoint and Veeva, right through today.
There was a time when that approach made sense. Today, the platform model has outlived its usefulness, and the negatives outweigh the positives.
When document management platforms were developed, they brought basic capabilities such as check-in, check-out, and versioning with them. With the need for control, verifiability, and compliance with regulations defining the requirements for life sciences, there was a good fit.
The systems were remarkably expensive to acquire and operate. Users were, to say the least, not enthusiastic adopters, but it was the technology we had, and it addressed a set of critical needs.
That was then. It is 2020 now, and we do not need the cost, weight, and inflexibility of a document management platform to have basic document management capabilities. Plus, the price of the platform model is too high.
Clinical Operations team members expect software to be easy to use and available immediately. They do not expect to license software, spend months configuring it, followed by months validating it, before they can use it in production. The idea of that type of software adoption process seems genuinely crazy to the current generation of clinical operations users.
But Let’s Keep the Integration Capability
There is one powerful argument remaining for the platform – integration. That is, the need for different parts of the clinical operations constellation of applications to talk to each other. For my CTMS to talk to my TMF solution; for my EDC solution to talk to my Patient Recruiting system.
Here is the weakness in that argument. With today’s technologies, there is no particular benefit to having multiple solutions provided by the same vendor. We can easily integrate systems today with a variety of technologies, for example, REST APIs that allow applications to “stand by” for calls and data from other applications. The details aren’t important. What matters is that INTEGRATION DOES NOT REQUIRE A PLATFORM.
And if we can ditch the platform, we are free to select the best application for each functional area. The best CTMS. The best ETMF solution. And the best clinical quality solution.
In the software business, this is called the “Best of Breed” approach to selecting software, where each business area can choose the best solution for their needs and does not have to compromise because the organization is dictating a single vendor or platform. The battle, between a best of breed approach and a “suite” or platform approach, has been going on since day one in the software industry. You see it in the way that the biggest software companies acquire adjacent solutions (e.g., a general ledger application becomes an ERP solution, which then incorporates HR management capabilities).
That serves vendors well, but the business users poorly. And since platforms have many negatives, and since we do not need single-vendor platforms to deliver the integration that the business wants, the question is, can we not, finally, kill the platforms.
But keep the integrability — I mean the cannoli.