Life is complicated, at home and work, day in and day out. The complication has only been multiplied by the rapid infusion of technology in our lives. Despite streamlining and simplifying many things, technology creates an environment that can overwhelm us with an abundance of stimuli and a surfeit of information. So much so, that unless we manage our world well, our capacity to absorb that information is overwhelmed, and our attention span wanders.

It happens to all of us over and over again.  When working on completing a particular task, my mind wanders to other tasks, and then, wait – is that an alert I heard on my phone?  I check the message immediately, because I am helplessly predisposed to do so, and lo and behold I have another item requiring my immediate attention. I am off down that rabbit hole and have lost my focus once again.

In our biopharma work, not only does this plague us all in daily desk work, it burdens us at the enterprise level as well. In addition to technology-driven distractions, we have what I call “initiative overload”. In conjunction with a persistent influx of text messages, we have a steady stream of overarching stimuli: multiple concurrent corporate or department initiatives, each with a “high priority.”  How (and where) can we focus when:

• These initiatives are competing for the same resources and attention.
• These initiatives are additive, in that they are extra work on top of our daily jobs.
• These initiatives often have overlapping goals and targets but are not aligned, resulting in duplication of effort and/or conflicting methods and solutions.

In biopharma operations, it is common for well-intentioned people to be working very hard on any number of initiatives which end up taking longer than planned, uncover additional complexities, and/or exceed budget forecasts and expectations.  I attribute many of these stumbles to a lack of “allowed” focus, the word “allowed” being stressed.  It is not that we do not focus, but rather we are not allowed to contribute meaningfulfocus to a particular effort because we have too many other conflicting initiatives in which we are participating. We are constantly shifting our focus from what we were doing to the new “immediate” need and in the end, none of the initiatives get the full attention required to be successful.

I have tried to manage this condition in my personal life. I put my phone away at family dinners and during other conversations, so I can devote my full attention to those interactions in order to get the most out of them.  I turn off “push” notifications of the latest distressing news, and I try to evaluate competing priorities before agreeing to the next tempting activity. A consciousness of the practical limits of time and attention, and the confidence to challenge the expected and the politically correct, can bring order to the array of priorities. Putting some initiatives aside to focus on one (or fewer) at a time will likely mean a better, faster output of work, and bring forth the best ideas and effort.

When confronted with multiple initiatives, participation in all, and meaningful contribution to all, are inversely proportional to one another.  The more things you are doing at one time, the less well you are doing any one of them. Management has the responsibility of improving this focus problem, through clear leadership, triage, resource allocation and budgeting. But all of us need to be vigilant to create an environment capable of productive focus.

Steve Shevel

Senior Associate

© Waife & Associates, Inc., 2019

According to Wikipedia, Fear, Uncertainty and Doubt (FUD) is “a strategy to influence perception by disseminating negative and dubious or false information and a manifestation of the appeal to fear.” This phrase dates to at least the early 20th century. How does this relate to the present common usage of disinformation related to software, hardware and technology in the biopharma industry? Well it is actually closer than you would think, so let’s have a look at some data management related issues, which are not new but obviously also not solved either.

There are quite a number of scientific evaluations which examine the impact of “wrong” data on study results. Whether this is because Source Data Verification (SDV) didn’t catch it or because edit checks were insufficient – all these studies show high robustness of collected data against errors. Nevertheless, we are all afraid of missing or erroneous data (Fear), we are uncertain about the number and kind of edit checks we need (Uncertainty) and we doubt that our monitoring and data management forces are doing enough to provide us with data quality which will be matching regulatory expectations (Doubt).

It seems that there isn’t much motivation to change the situation. CROs have sponsors pay for “intensive” data checking, sponsors want to be “on the safe side” and technology providers try to sell some innovations which claim to solve everything. Meanwhile, we are trying to use new clinical research information technologies without taking into account the impact this may have for the overall data flow and corresponding processes. What started with EDC (applying paper processes in an electronic world) continues with eCOA and mHealth approaches.

In a recent client example, we observed five different data sources, multiple technology providers plus a Data Management / Statistics CRO who was in charge to transfer, consolidate, clean, transform and eventually analyze the data. Primary endpoint data was coming from an eCOA device via a symptom score. Of course the sponsor was concerned about the completeness, the consistency and the overall quality of the data. Despite the fact that the eCOA data was transferred to the database at the eCOA vendor instantly, the transfer of eCOA data to the DM CRO didn’t happen until after 2 months of study start, and at that time 80% of the overall data had already been collected. Similarly, uncovering errors within the eCOA system or device handling issues by sites and patients could only be discovered relatively late in the process, after data transfer.

This leads to the ongoing and critical questions all sponsors have about proper data flow, processes and the single point of truth for all data. This is becoming more complicated as the number of different data source keeps increasing. Does the technology solution need to be one single big repository? This topic has been discussed for many years, with quite different answers coming from technology providers (or CROs) on the one hand, and company-specific solutions among sponsors. To define and consistently execute proper processes for these scenarios is at least as important as the technology itself. This requires people with technical understanding, flexibility and process thinking. The challenge will be to identify, develop, recruit and maintain these people who will do the work in this evolving environment.

Eventually, the combination of people, processes and technology (in this order!) can make a difference. It will enable us to gain better efficiency and could be the route to guide us from FUD to CCT: Confidence (we do it right!), Certainty (we do it in the most appropriate way) and Trust (we do it with the best people).

Detlef Nehrdich

Senior Associate

© Waife & Associates, Inc., 2019

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.