Several years ago, my small company was acquired by a very large company and I went from being a Clinical Department of one to suddenly managing a small army of inherited personnel. As the new team discussed various processes and procedures or “the how” of the various functions we performed, I quickly noticed the frequent use of the phrases “we’ve never done it that way” and “we’ve always done it that way”. I found myself becoming irritated with these answers and I realized that it was because those are lazy answers that are a result of ingrained rather than creative thinking. What irritated me more was that at some point, someone had taught -either actively, or through inaction – that this was an acceptable answer. So I immediately put a moratorium on the use of those two phrases. At first, it became a game to see who would slip up and use one of the banned phrases but I was amazed at how quickly and enthusiastically everyone picked up on the real reason behind this approach. They really enjoyed thinking about and even challenging the rationale – or “the why” – behind the how rather than simply “doing what they’re told”. In some cases, this new way of thinking taught them about solid reasoning behind why a certain process had “always” or “never” been performed in a certain manner but where things really got interesting was when there was not a good reason behind why something was being done a certain way. Because they had been empowered to challenge the why, they began to dig in and question the status quo. And that’s when the magic happened, because that is when individuals took ownership and really began to think about the why behind the how. I have since banned those phrases in every department I’ve managed.

Developing (or re-developing) a Clinical organization can be thought of in a similar manner. Because a certain organizational approach was successful once does not necessarily mean it will work in all scenarios. We’ve all had the boss or co-worker that begins too many sentences with “At my last company…” Admittedly, I am as guilty as anyone of using that phrase but we have made a concerted effort to limit that approach at my current company and it has a positive effect. Again, there may be strong evidence supporting a certain approach but simply regurgitating previous philosophies does not necessarily make it the right approach. And it doesn’t make it the wrong approach either. A single approach to developing a Clinical organization may work quite well throughout a career as long as that approach is fulfilling the company’s needs for the right reasons not because it is the easiest solution (i.e., I’ve always done it that way). Below, I describe two scenarios that provide some food for thought with regard to how best to set up a Clinical organization in a start-up environment.

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Scenario 1: At this very small start-up company, how we did things and why we did them that way were closely linked. Budgets were tight and everyone in the organization was expected to get their hands not just dirty but grimy. Most of the senior staff spent a significant amount of time in the clinic covering cases and during a lull in clinical trial activity, I ended up doing bench testing for design validation. We had no Marketing personnel until after we started a grass roots sales effort. It was easily the leanest company in which I’ve worked and the why behind this was to make the company a desirable acquisition target in the middle of the worst economy since the Great Depression. This led to an incredible single-mindedness in our company goals. In the Clinical group, I had one highly experienced clinical employee and one seasoned full-time contractor, both of whom could cover cases and monitor sites – what I call “Super CRAs”. On the data management side, I’m obsessive about controlling study data because if you don’t have data, you don’t have a study and therefore I had always had that function in-house to that point in my career. But in this case, we couldn’t afford to do data management in-house in a compliant way. So we found a small CRO dedicated to high quality data and almost fanatical customer service to do our data management (complete with good old paper CRFs). This combination was the most cost-effective solution for our situation. In farming out the database work, I did something I had never done before and was also extremely uncomfortable doing. And it all worked to perfection. The Super CRAs lived up to their name and our CRO was stellar. We successfully completed two IDE studies leading to two market clearances and our small start-up was acquired shortly thereafter.

Scenario 2: With the victory of Scenario 1 fresh in my mind, I proceeded to attempt to implement that model in my very next company. But quickly, that approach proved infeasible. I inherited an employee who had excellent procedural knowledge and could cover cases but was new to clinical studies and therefore had no monitoring experience. This nixed the Super CRA approach, so we looked to a CRO for our monitoring function. The decision process of choosing a CRO was crucial in this case. We spoke with several CROs and most came in with boiler-plate quotes that in some cases showed evidence of cutting-and-pasting from a previous proposal. In other words, quotes that were best for the CRO’s process. The one that caught my eye was not necessarily the lowest bid but the bid that was structured in a way that indicated the CRO had listened carefully to our story and understood the why behind our situation in addition to the how. We hired them and they quickly grew into a trusted ally. On the data side, we required a system with little or no capital outlay, a high degree of flexibility for multiple studies, and potentially unorthodox approaches to data management in order to demonstrate the value of our product. The CRO I had just used in Scenario 1 could not accommodate this approach. And our data approach was a very big part of our long-term approach in this scenario. I had access to a fantastic in-house Data Manager and we found a new, highly efficient, low cost, hosted electronic data capture (EDC) system that far exceeded our expectations. In this case, doing the data management function with a hybrid in-house/hosted approach and farming out the monitoring function proved to be the most cost-effective. And believe it or not, this was the first time I had implemented an EDC system, so once again, I was doing something new with what I consider the most important function in clinical research. Even though I was coming off of a great success using one model for a clinical organization, circumstances (and the why) dictated a different approach and that approach also proved very successful.

So what did I learn from these two scenarios? In short, one size does not necessarily fit all. Stubbornly implementing the same solution in every scenario can lead to costly mistakes including having to re-start a study (I’ve done that scenario as well and it is not something you want to experience). If I had insisted on the same approach in both scenarios above, I likely would have lost a great employee in Scenario 2. While replacing an employee may not sound ominous, consider the lost experience element. You can never completely replace that employee’s experience with your product and/or study. Add to that the cost and time involved in the hiring process, training, and bringing someone up-to-speed on top of the lost experience and your efficiency suffers. In other scenarios, replacing an employee might actually improve efficiency. In either case, this must be carefully assessed. Efficiency gets amplified in a start-up because a loss of efficiency is lost time and lost time is quite literally lost money.

My point is simply that when putting together a Clinical organization (or any organization), do not simply focus on how you will accomplish your goals. Make certain you and your team understand the “why” as well – why these goals, why are they important to your company’s success, and why are they important to your investors? The why can be very different from company-to-company and even department-to-department but it can also strongly influence how things get accomplished – often without people recognizing the interaction. Maintaining flexibility and being creative in developing your Clinical department can be crucial to your company’s success. Make sure you are regularly revisiting the “why” behind your goals so the perfect alignment that was the founding vision of the company is maintained as your organization grows.