When Process Improvement is Skin-Deep

Process inefficiency and illogic is rampant throughout our industryin every sponsor, CRO, and investigative site. This new column will examine clinical trials operations from the process perspective. Its goal is to stimulate readers to recognize when, why, and how to improve the effectiveness of the way they do their work. The many quick and effective ways to improve this situation start with awareness.

Executive readers may protest that their company is well aware of the need for process re-engineering and that they have already spent millions to do it. Middle managers will groan at more talk about process improvement because they often have been the victims of their executives re-engineering projects. The frustration and lack of impact that result from these projects comes from the fact that too often, process re-engineering is only skin-deep.

Does this scenario sound familiar? A corporation decides to re-engineer its company to develop best-in-class practices. It spends millions on high-level interviews and executive brainstorming which, predictably, produce high-level goals like triple our pipeline in three years, or reduce our costs 10% every year for 10 years. Multicolored laminated diagrams elucidating the workings of interdepartmental teams are distributed company-wide and imprinted on coffee mugs. These goals become the objectives for middle managers to implement, the success of which will determine their bonuses. Meanwhile the executives congratulate themselves on having re-engineered the companythey have the wall posters to prove it. The rest is just details.Details indeed. How is a department supposed to respond to this dictum? Accelerating time-to-market is a key business strategy. With a re-engineering recommendation as specific as Regionalization of monitoring resources may be more productive, what is a manager to do?

The answer for clinical operations managers is to get the skills and tools needed to apply management action and group process to improvement tacticseither to attack inefficiency or to exploit a competitive advantage. The problem is, this is where the money runs out. Corporate leadership is often ready to spend millions on the skin cream, but has not been helped to understand the cost of the surgery needed underneath. Even when executives recognize that more detailed work is needed, they may find that their discretionary budget has run dry. So they turn to middle managersin time-honored traditionand say: Implement our Seven Points of Light, and do it while you get your regular work done.

Operations managers may have in fact been deeply involved in the re-engineering effort, at least in terms of time spent in interviews, team meetings, and exercises. But often they do not see the results of their input translated into a useful operational plan. In this way, managers feel the process improvement was done to them, not for them. The more frequently this happens, the greater the skepticism about process improvement that spreads among all staff.

This irony is repeated every year across our industry. The more it happens the worse it gets. Left unresolved, the inefficiencies create more financial pressure, which, in turn, demands more effort from clinical operations groups, who then have even less time to correct the problem. Clinical development is the longest, most costly part of bringing a new therapy to market. It deserves a sophisticated, deep approach to process improvement.

Although there is value in aligning a vast corporate enterprise around a set of clearly defined business strategiesespecially for the sprawling merged entities we have in our industry, and the CROs that have grown far beyond managing by instinctit is also essential to develop specific tactics for implementing those strategies. Once strategies are in place, those who suggest they are bringing value to the corporation through process improvement must be willing to get their shoes muddy, and they need to have the skills to lead the operations group through that mud.

Clinical operations managers need to anticipate this impact of skin-deep re-engineering and arm themselves with skills and resources to respond, while trying to influence the situation proactively. Here are some suggestions. Future columns will discuss these and other techniques in more detail.

• Routinely propose budget dollars and resources for process improvement in your annual plansand defend them vigorously.
• Raise the consciousness of your bossesand their bossesabout the importance of tactics.
• Learn tactical improvement techniques, such as fact-based interviewing and process mapping.
• Watch out for reorganization plans based on politics instead of process.

Organization charts are the language of a corporate personathey are too important to be determined by whose job needs to be protected or how to support a managers compensation through head count.

• Protect yourself withand learn frommetrics. Measure the way you work now so you can see how the imposed changes affect you, for good or ill.
• Dont try to save a bad process with technology before you understand the process problems.

Clinical development is in crisis. Superficial re-engineering does not help. It is in your hands to make your organizations inner beauty shine through. Beauty may be only skin-deep, but process improvement need not be.