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Management Consulting for Clinical Research

I Can’t See You (Monitor, December 2007)

A current business buzzword seems to have increasing relevance to the relationship between clinical development functions and information technology departments: “transparency”. More and more, we hear clinical operations functions complain that they aren’t getting the information they need from IT or data management. We hear the same from data management about IT, or IT about clinical operations, for that matter. Each of us is the one who’s hard-working and well-meaning, and it’s the other guy who’s withholding information we need. If there is one message each group can agree on, it’s that “I can’t see you.”

 

Opaque and Obstinate

How does perceived opaqueness stand in the way of clinical IT? In at least four areas: Communication, Planning & Management, Requirements, and Performance. In each area, despite their diverse business impact, the underlying sentiments are common:

I don’t understand you

I don’t want you to understand

I don’t want you to know what I know

I don’t want you to judge us

I don’t think you are helping me

I think you are withholding what I need

I don’t trust you.

 

These are powerful sentiments, fundamental to human interaction, and turn what should be “only business” into the personal. What are we being opaque about? In the following examples, I will pick on IT, but with a little tweaking, you can apply them equally to IT’s customers in data management or clinical operations.

 

First, clinical groups will complain that IT is being opaque about, well, information technology! “I go to them and ask for something simple (sic), and all I get is a lot of technical mumbo-jumbo back”. Indeed, at a conference I once attended on the nature of professions in society, the very definition of a “profession” was proposed as “something which one group knows that everybody else doesn’t,” and it was pointed out that it was essential to a profession’s success to create a language (a vocabulary) which was impenetrable to those outside of the profession. IT professionals are masters of this technique (as are pharma’s physicians, scientists, statisticians, and regulatory affairs experts). So as in the famous line from the film Cool Hand Luke, what we’ve got here is a failure to communicate.

 

Second, and quite different, is the lack of transparency around the deliverables that groups are expecting from IT. For any given project, often as not, IT’s customers feel they have little or no visibility into progress, timing, potential risks, unforeseen stumbles, and the ultimate completion date. Closely related to this, and more inflammatory, is the question of how much something will cost, or how long it will take. The typical consequence of this opaqueness, driven by that list of sentiments itemized above, is a stalemate across the conference room table:

 

ClinOps is waiting for a set of reports to be programmed out of its CTMS tool, and IT says, “mumble-mumble-technical, so it’s not ready.” When will it be ready? “As soon as we can! – don’t you trust us?” Well, since you ask, no.

 

At worst, it ends in a game of executive “chicken”, where we find out which VP is more powerful (or cares about us) that week.

 

Opacity extends deeper, into the nature of the deliverables we are expecting from IT. Let’s take the example of requirements for a new software application. IT asks for our “requirements” and we (think) we tell them. The process IT uses for determining these requirements, prioritizing them, and applying them, is often unclear to the requestor – especially if the results of the requirements gathering aren’t recognizable to those who asked for it.

 

Support services for IT applications is another common source of opacity. Again, the technology’s users think it is obvious that what is required is to have any and all of its questions answered whenever they have them. The fact that this might not always be possible is somewhat acceptable – life is imperfect – but the reason for this imperfection escapes us. The procedures, capabilities, scope, challenges, obstacles and costs of providing near-perfect support is opaque; only the shortfall in performance is clear. And who’s to blame for the opacity? Generally speaking, it is the service provider who has the responsibility to explain themselves, no matter which side you are on.

 

All of this can be summarized as an opacity of performance. Common IT performance issues, such as meeting commitments of schedule and budget, or maintaining network uptime, or Help Desk response time and accuracy, cannot be understood if the reasons behind the performance shortfall are opaque, or if the expectations are unreasonable, or if (most typical), the communications come to a mistrusting standoff. This opacity itself is the worst performance of all.

 

Transparent and Cooperative

What should IT (or ClinOps, or data management, if they are the guilty ones) do to make themselves visible? In many organizations, the dilemma of transparency is increasingly known but seems intractable: the connection between performance and trust is inseparable, and seemingly unfixable once it has descended into a dark negative loop. But misunderstanding is also a fundamental cause, and surely this is approachable, and redeemable.

 

We talk about international culture gaps freely, with justifiable sensitivity, but the interdepartmental culture gaps are somehow an unspeakable embarrassment, a source of angry stonewalling, something to be kept in the closet. And this does no one any favors. We can start by translating our professional vocabularies, and then move to comparing our everyday vocabularies – what does “on-time” or “commitment” mean to you? What does “easy to use” or “soon” or “expert” mean?

 

Most importantly, we need to open up our worlds to each other. Have you been to a store, or airline counter or hotel check-in desk these days, where the salesperson stops staring at their flat-panel computer screen, and turns it around to show you what she or he is looking at, as a way of explaining what you are buying (or why your plane is late)? It’s a rare but marvelous experience. The sharing is so unexpected that mistrust evaporates in an instant. That’s the power of transparency. Perhaps we should all, literally or metaphorically, turn our laptop screens around to face the person across the conference room table. Instead of stubborn confrontation, perhaps we can share our business secrets and see our common ground.

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