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Management Consulting for Clinical Research

The Longer It Takes, the Better It Isn’t (Monitor, 2010)

Delay in no way guarantees thoughtfulness, as some wishful thinking would have it….In the worst cases (which are not uncommon), delay leads to cynicism and passivity.

 

It has been said that one sure way not to win the lottery is not to play it. Without condoning indiscriminate gambling, and notwithstanding the parallels between buying software and gambling, we should be increasingly concerned that the caution with which biopharma approaches information technology may be turning into cynicism, and may be keeping our clinical research organizations from practical and much needed benefits.

 

Delay is Not Benign

Delay in IT selection and implementation is not benign. It is not simply a matter of “luxury” deferred. And delay in no way guarantees thoughtfulness, as some wishful thinking would have it. The dilemma of IT delay is that operational needs and software to fix them are increasingly fleeting in our rapidly changing business and technical environments. A need expressed one year may be gone (or greatly diminished) in 18 months. I have seen executives who count on this phenomenon, thereby proudly “saving” money. But these are false savings: if the need was truly there to begin with, the delay only represents a period of sub-efficiency and missed performance.

 

Similarly, the rapid pace of technical change is the serpent in the garden of software use. Delay in software acquisition and implementation means that the users’ needs are ultimately addressed by technology which may no longer be worth the investment (compared to newer, often cheaper, alternatives), and at the same time, the newly enabled users will be disappointed they are not using a platform or interface or function set which they find commonly available in their non-business lives.

 

Delays in IT projects have many causes, driven by sponsors as well as vendors:

• Cultural caution (“I want to analyze this some more”)

• Financial restraint (“We’ll wait until next year”)

• Mistrust (“I remember how badly the upgrade went last time, so let’s hold off awhile”)

• The grass is greener over there (“Gee look at that new vendor, or that new strategy”)

• Acquisitions (“Rumor is, we’ll get acquired in a couple years so let’s sit tight”)

• Personnel turnover (“The new VP doesn’t like that vendor” or “The vendor’s management changed and we have to wait and see”)

• Team management (“We have to have the input of all the stakeholders, and darn it’s hard to get them all together at the same time….”)

• Poor software development practices (The new release is really buggy)

• Excessive legalism (the downside of professionalizing, and isolating, contract administration)

• And so on.

 

But all these excellent reasons for inaction have to be balanced against the cost of delay. Besides not meeting the operational needs that prompted the project in the first place, delay has other insidious side-effects:

• Delay softens the demand (which may mean they weren’t important, but also may mean your organization is losing willpower)

• Delay softens the energy behind the project, the project champions move on to other things, and the staff perceive a lack of drive for improvement from management

• Focus and talent drift away; like fielders on a baseball team behind a slow-working pitcher, it’s hard to keep your edge. The mind, and the project, drifts.

• In the worst cases (which are not uncommon), delay leads to cynicism and passivity. Staff who put in considerable effort in helping the project leader analyze needs and specify requirements see that little or nothing comes from their efforts, creating a dangerous negative feedback loop that will undermine future efforts and poison the corporate culture.

 

Less Time, More Benefit

What are the antidotes to delay? The primary solution is one of cultural change: a corporate environment where impact is favored over cost-savings, where performance instead of caution still matters, where contributing to staff cynicism is a mortal sin.

 

Based on such a foundation, the research organization has to approach its IT projects with a sense of urgency, flexibility, and trust. Since trust is bred by success, quick successes should be sought out (the essential opposite of delay). All of those involved in identifying needs and solutions must understand that time is of the essence, and that some benefit is better than none. And as always, senior management support for this strategy must be vocal and prominent.

 

Speedier IT implementations can be obtained through:

• Focus (prioritize and re-prioritize, not just which projects to do, but what to do in each project; forego nice-to-have features for those that drive key business objectives)

• Understand what is important (essential to the focus referred to above; every employee should always be clear as to the 3-4 things the research organization must achieve in the near term)

• Narrow team membership (nothing causes delay in the soup like too many cooks; up-end your corporate fetish for broadly populated project teams and include only the absolute minimum contributors who you can count on to participate knowledgeably)

• Set aggressive deadlines (pick a date which seems impossible, given your organization’s history, and then move it up a month or two)

• Ensure sustained senior management visibility and oversight (they have to stay involved and stay on message)

• Implement sustained, closely managed, tightly scheduled vendor management (do not confuse arms-length oversight with trust – you cannot set and re-set expectations with your vendors often enough)

• Trumpet your successes, and the features and benefits of the new software, through actual stories from your experience (the proof is in the pudding and everyone needs to hear a lot about it)

• Keep moving! (side-step obstacles, shorten your objectives list when necessary, and keep that sense of urgency).

 

Looking back at this list, I realize the same advice could be given to clinical trial study teams. Hmm. Does reducing delay have resonance for the essence of our work?

 

Speedier implementations will require important changes in the skills and perspective of research staff, in sponsor-vendor trust, and in project execution. An organization that tries to move in these directions may win the lottery after all.

 

©Waife & Associates, Inc., 2010

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