Clinical outsourcing leaders buy “innovation” and tech solutions for clinical operations teams: the latest in decentralized clinical trial technologies, clinical trial management solutions, AI-enabled patient recruitment solutions. But for themselves?

I was chatting with our Head of Marketing, Karen Wills, about the scarcity of thought leadership for clinical business operations. It is hard to find more than a few published articles in a year and there’s so little exciting news that no wonder that clinical outsourcing has hardly kept up with innovations in technology.

It’s an interesting angle. Clinical outsourcing leaders buy “innovation” and tech solutions routinely for clinical operations teams: the latest in decentralized clinical trial technologies, the smartest clinical trial management solution, the slickest AI-enabled patient recruitment solution. But for themselves? Not much, as I have personally experienced over the last 15 years. The R&D procurement professionals remain entrenched in manual work, dreading the use of generic procurement solutions that have been pushed by “corporate” but are widely recognized by the industry for delivering for clinical!

I clearly recall 2 conversations with distinguished leaders in our industry, both from top 10 pharma. First was about Ariba from SAP, specifically how “every big pharma has it”, but the core spending category, clinical, is not procured through it. “Nobody uses the tool, it’s clunky and nothing more but a glorified email to exchange attachments! The service providers hate everything about it – formatting, lack of structure, non-intuitive interface, business model, e.g. you pay fees to use it. Internal users hate it too! Yet it’s there and we cannot look at anything else while it is still there!”

The entire discussion lingered with me for a long time. Why? Why can’t Ariba, or GEP, or Jaegger happily co-exist next to fit for purpose technology built for pharma outsourcing, such as Clinical Maestro? Each has its own unique purpose: every organization needs a corporate procurement solution, and every organization needs a fit for purpose set of solutions to accommodate unique buying needs. The stakes are even higher when you consider the hundreds of millions of clinical spend, and the top pharma don’t even have an accessible proposal database and are entirely lacking analytics. Of course, you can draw a parallel to everyday life: nobody uses just one booking site. You have Open Table, Uber, Lyft, Expedia, hundreds of sites that are all about booking different things: restaurants, hotels, rides. So why would a top pharma spending >$10B per year have just one broad procurement solution? It doesn’t make sense. To provide a quote from the Netflix Witcher series: “When the problems are different, they require different solutions.” Whether sci fi monsters or complex clinical RFP templates, the challenge is the same: finding the correct solution to each unique problem.

Despite the resistance, the tide is changing. With fewer people, more pressure to deliver faster, have data transparency and instant access to intelligence, top R&D spenders cannot simply “do nothing,” because the cost of doing nothing is too high. Speed is the name of the game and error prone manual work can no longer keep up with the complexity and demands of today’s clinical development world.

My second conversation was about custom solutions in clinical outsourcing. Many pharma companies paid millions of dollars to top consultants over the last 15 years to develop custom solutions for procurement, vendor management and clinical forecasting. These custom solutions were designed to be maintained largely in-house by internal IT teams, with support from the consultants. Unfortunately, as pharma reorganized and scaled back costs, internal IT departments shrunk and maintenance contracts ended, resulting in an ecosystem of aged, unsupported, difficult to use solutions that are largely incapable of accommodating new outsourcing models, e.g., switching from fixed unit to variable sourcing. As my industry colleague described them: “These systems are absolutely awful; technology is so ancient that we may need to leave them overnight to refresh; the reporting is largely absent; nothing can be easily changed.”

“So why you do you still have them?” I asked.

“One word – politics. The costs of the custom builds may not been fully amortized; it could cost somebody their job requesting a massive write off and switching spend to SaaS subscriptions. It will happen though – hopefully in this reorganization. We need someone new with the courage to go back to the drawing board.”

These two conversations are just the tip pf the iceberg. A common theme has emerged that recognizes the pain points of old infrastructure and the advantages of fit for purpose SaaS. However, the voices are disparate and industry organizations still painfully dormant. PCMG event in Europe is a staggering example of this phenomenon. This esteemed forum brings together some of the industry’s best expert voices and runs the best outsourcing event in pharma: content rich, well planned and presented, and stylish. Yet, in the 4+ years that Clinical Maestro has been trying to partner with the organization to marry thought leadership with technology, they have been radio-silent, continuing to create and publish new Excel templates. Why would such a thought centric institution avoid partnering with the only company in the industry who is building technology innovation in their field? One PCMG leader told me: “Technology is expensive.” Is it? I wish we could move the discussion from “cost” to “return on investment.” Manual bid due diligence in Excel is not free: it comes with expensive errors and extensive labor. Lack of vendor performance oversight has dire consequences on audit findings and inspection preparedness. Sourcing without benchmarks costs the company 10% or more in extra cost on average. There are excellent examples of successful collaboration between industry forums and private companies, the first one that comes to mind is DIA and Veeva. The results of harmonizing TMF standards? Billions of dollars in industry savings and, of course, Veeva benefited as well, a true win-win.

Of course, fear of change is part of the reason that has made clinical business operations domain leaders stagnant. It is easier to keep working in Excel, criticizing generic solutions and evangelizing newest technology trends, e.g., AI, machine learning, bitcoins, while changing nothing. In truth, until now technology wasn’t really exciting. No wonder the experts shy away from generic solutions, quietly sabotage custom tools, and turn a blind eye to tech innovation. They have been burnt before! Sourcing technology was never complete and easy enough to use for sourcing managers to graduate out of Excel.

At Clinical Maestro our sole focus is to make clinical business operations technology exciting to clinical business operations users. We are domain experts and are building features with domain experts. Sounds cliché but is true – Clinical Maestro is an expert solution for expert users built by expert users.

We set to change the tech landscape and, through this, will change the thought leadership landscape as well.

Back to my discussion with Karen: if there isn’t enough exciting thought leadership, we will start the conversation, engage others in the industry to join and write about it. We challenge you to join our pledge – to modernize clinical outsourcing.

In the quarterly Clinical Maestro newsletter and our own series, the “Straight Talk”, we are bringing clinical outsourcing leaders’ voices forward.

Welcome now to our Blog Series: Innovation in Clinical Outsourcing!

By Anca Copaescu
Founder and CEO, Clinical Maestro by Strategikon