After decades of dragging its feet, the biopharma clinical development world is finally embracing the adoption of information technology in support of clinical development. The industry as a whole has overcome the problems of operating in a regulated environment, fear of change, inadequate budgeting and unclear software governance.

Whst is ironic now is how far to the other end the pendulum has swung, in the acceptance and reliance on technology as the solution to most any clinical development operations problem. Do any of the following sound familiar?

• Problem: We should be doing more vendor oversight.
• Solution: Let’s get a new CTMS system.

• Problem: We should be doing Risk Based Monitoring.
• Solution: Let’s get RBM software.

• Problem: We should be collecting more real-time personalized patient data.
• Solution: Let’s implement mHealth.

While the implementation of these tools can be part of a solution to the operational issues we have, they do not represent the entirety of the solution – and that is precisely where the frustration with technology stems from. Users and executives alike have the unrealistic expectation that the tool itself will solve the problem.  But in reality, it is the way you adapt to and use the tool that is the primary factor in achieving a solution. Indeed, implementing a new software application may not be the most important step you need to take.

Most sports activities provide a telling analogy, where in any given competition, the athletes by and large all use the exact same equipment.  In tennis, most players use the exact same racquet.  In baseball, there is very little difference between the bats, gloves, and shoes worn.  The same goes for hockey, basketball, skiing. Indeed in basketball everyone hasto use the same ball.

The equipment itself has progressed over the years, which gives athletes today an edge compared to previous generations.  For example, you would be hard-pressed to find any professional tennis player using a wooden racquet today.  But why are some athletes more successful than others? It is definitely not the equipment.  I can go out and buy the exact same racquet as Rafael Nadal or Roger Federer, but that will not allow me play tennis at their level.  Their success is a combination of raw talent, practice, determination, conditioning and, yes, taking advantage of the technology (their racquets) to complement their game, by leveraging that technology to highlight their strengths and minimize their weaknesses.

And you do see even top athletes change equipment when things are going bad for them. Very rarely does this make a difference in their performance. Their performance improves when they have correctly diagnosed the technique, attitude and skill deficiencies applied to using the tools.

This same example holds for biopharma and the use of information technology.  Many biopharmas use the same piece of technology (or very similar technology) for data collection, a CTMS, safety reporting, an eTMF, etc., and yet some companies (or projects within companies) are more successful in clinical development than others.  Like sports, the spectrum of success and optimization lies in how the organizations use those tools.  Are they taking full advantage of the functionality that supports their goals? Have they adapted the tool to fit within their organization?  Have they defined their processes to limit duplication of effort and optimize workflows? Technology provides the means to help us get there more easily and efficiently, but it will not get us there on its own. It’s the environment around the technology which is the key to solving the operational issues that confront us every day.

Another obstacle biopharma tends to trip over is a reliance on the developer of the information technology to provide guidance on how to use it.  This is not fair to the developer nor is it fair to ourselves.  Technology vendors are, for the most part, technology specialists, by definition.  They are not clinical research and development specialists, and don’t market themselves as such. So, why do we ask them for help in using their tools when the questions we ask are fundamentally operational, and not technological?  Most vendors will, of course, be happy to try and help you, as it is their system you are using and they have a vested interest in ensuring your satisfaction, but this relationship often ends badly and unnecessarily so. Our sports analogy teaches us again: Roger Federer does not enlist someone from Wilson to be his coach nor does Tiger Woods ask someone at Nike to help him work out his drive and short game.  Instead, such professionals enlist the help of specialists who are experts in the sport they are playing so that they can get the advice they need to win.

When confronted with your next clinical development operational issue, think back to the analogies from other industries and by all means buy, enlist, or lease the appropriate information technology that will help you address the problem.  But if you want to be successful, be sure to devote enough time, attention and money to defining how to optimally use that technology within your individual organizations.

For the arrow to hit the target, the archer has to be the one to get it there.

For further discussion or assistance on this topic, reach out to Waife & Associates, Inc. at www.waife.com, or email me directly at shevel@waife.com.