Not at Your Service

August 1, 2004
Ronald S. Waife

Ronald S. Waife, MPH, is president of Waife & Associates Inc.

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2004,

Move away from the "service" model if it means being subservient.

Move away from the "service" model if it means being subservient.


For many years now, it has been fashionable to work on corporate processes by encouraging a "customer-vendor" relationship between departments. I have been as guilty of this as anyone. In listening to the problems facing clinical development departments recently, however, I have come to realize that this concept is either misapplied, misunderstood, or simply a mistake. Unless great discipline is exerted on all sides, "customers" are poorly served and "vendors" are exploited.

You are my customer, I suppose
The original concept of treating each other like we are each other's customers is drawn from many good intentions, and merges many process improvement philosophies and techniques. At my company, we use a "voice of the customer" technique, for instance, which emphasizes this style of thinking. TQM (Total Quality Management) teachings of various flavors use this terminology. Process Mapping-the visualization of complex workflows-is sometimes presented in this fashion: Who is your customer? Whose customer are you?

In many ways, talking about each other as customers is not unlike the Golden Rule: treat your organizational colleagues the way you would want to be treated. Using terms like "customer," "vendor," and "service" puts a warmer face to "inputs/outputs," or "deliverables."

Customer orientation as a corporate process concept was long overdue when it first appeared. Most companies-pharmaceutical companies among them-desperately needed to overcome the detrimental "silo" ideas to eliminate the pointing fingers of blame, and to show the interdependencies people share in a complex organization.Examples of such poor relationships at pharma companies were (and still are) legion: between clinical operations and clinical data management, biostatistics and medical affairs; regulatory affairs and product marketing; investigative sites and monitors (CRAs); chemists and pharma-cologists; informatics and everybody.

But there are problems with this kind of language. For instance, if everyone is everybody's else's customer, is anybody "making" anything, or are we all just "buyers" expecting to be served? In fact, not everyone is a customer of someone else. Sometimes, for instance, people are other people's bosses. Sure, you can treat your boss as a customer, but it may be more important to follow his or her leadership rather than think about delivering him/her a service. Sometimes our colleagues are simply sources of money, or data-neither customer nor vendor. And sometimes we have nothing to do with each other, but if the mantra of customer-vendor is too ubiquitous, the corporation may be insisting that these folks develop a time-wasting connection in the blind pursuit of popular jargon.

Happy customers, missing the boat
More importantly, there are two fatal flaws in the everyone-is-a-customer approach. First, even given the legitimacy of the concept, the true "customer" of our work may in fact be at a much higher level than who we are trained to serve. For instance, the customer who is worthy of that name may not be the next person in the handoff chain, but rather the Clinical Development function as a whole, or your biopharmaceutical corporation, or the regulatory agencies, or even the patients you hope to help. Unfortunately, the customer focus approach almost exclusively encourages a pragmatic, heads-down, make-the-next-guy-happy mentality. This may not actually help your organization at all, if the focus should be at a much higher plane.

Secondly, the concept of "service" is misused. If we have customers, then we are supposed to "serve" them. This is where the customer concept can get really deadly. When we start to think about "providing a service," and then turn this into "being of service" to our customers, if we are not careful we can end up being "subservient." These words all sound pretty similar, but subservience means being a servant; it implies that the customer is better than we are, or more importantly, subservience means the customer's needs are more urgent than ours. It doesn't have to be this way, but when we overlay the customer focus superficially and without diligent rigor on age-old interdepartmental rivalries, that's what we end up with.

Some clinical research examples:

  • Clinical Data Management "vendors" take the customer focus philosophy to heart and concentrate on serving the clinical study manager. In doing so, they are forced to choose between losing their carefully built-up standards, structures, and efficiency, to serve the study team with flexibility.
  • Monitors focus so much on sites (their customers) that they allow consistently poor site performance in enrollment and data quality for the sake of "satisfying" that Key Opinion Leader.
  • Clinical operations is intimidated by its site "customers" into paying them more to use EDC (electronic data capture)-a tool which will in fact lower site workload if used correctly.
  • Biostatisticians give their physician customers in Medical Affairs everything they ask for despite what this does to the timeline, or despite the fact that the data may not yet be properly cleaned or of sufficient volume, or that the questions the physicians are asking take the company's eye off the ball.
  • Clinical operations tries "serving" CDM, and in trying to meet CDM's stringent view of data cleaning, ends up with an inefficient monitoring schedule and that classically unnecessary task: 100% SDV (source data verification).

In fact, having customers and serving them are not inextricably linked. It is possible to be customer-focused and yet not be subservient to your customers. "The customer is always right" does not mean that the vendor is always wrong.

Customers as equals
One way of looking at "customers" without becoming subservient is to see each other as equals, not servants. After all, if everybody is somebody's customer, we are equal. And equality brings several characteristics into play which are very healthy for a corporation: mutual respect, boundaries, expectations with limits, and a common multilateral goal, not a linear production line goal. It allows the Clinical Development department to focus above the level of the next handoff, and concentrate instead on the plan, the submission, or the patient. And it ensures that each profession can determine which of its values are corporate-critical.

How do we get to be equals? Good will and strong leadership are certainly essential, but human behavior and entrenched practices often require a little extra help to change. Fortunately there is a well-established concept in this regard: the Service Level Agreement (SLA).

SLAs are an invention of our service economy, and while they have been used in many industries, the concept is not widely applied yet in pharmaceutical firms, especially in drug development. An SLA looks very much like a contract. It spells out responsibilities, timelines, expectations, deliverables, authority, change procedures, and problem resolution. As such, it documents what one may have documented in a Process Mapping exercise, but does so in the language that societies have developed over centuries to bind people to a common purpose.

Initially, people often react badly to this concept. Why do we need a contract when we have worked together for so long? Why don't you trust me/like me anymore? Spiteful behavior can ensue: "Well, if you're going to write that down, I'm going to write down this!" "If you want this done on time, how about you doing this for me on time!" And as petulant as these sound, this is exactly the point. The SLA becomes a tool to generate an open dialogue that, without it, simmers below the service. The SLA's formality uncovers flaws, resentments, or missed expectations that were never articulated otherwise.

In the end, by going through this process, you may not need the formal document-just trying to write one may be therapeutic enough. But we are so increasingly interdependent across clinical development, and across all pharmaceutical company departments. This documentation of how that interdependency will be managed to both the corporate good and the successful treatment of patients may be necessary, at least for a few years, until old habits die off and mutual respect and understanding become second nature.

When your waiter tells you "I will be your server tonight," he or she represents in fact a range of products and services-the chef's creativity, the cook's execution, even the delivery truck that brought the raw materials. And you have your responsibilities as well-to arrive at the restaurant on time, to know what you like, to treat the staff well. The delicate flavors, the perfect ambience, a lovely wine are all the result of a combination of lots of people providing you a terrific meal, plus your ability to be ready to enjoy it. They are not your servants, and you are not a burden for them to bear. And as equals, server and served, customers all, we can go home well satisfied with a meal, and a job, well done.