There can be over a thousand people in a big pharma’s Clinical Development department, and yet the most important people in the process are not on our payroll. It can take 8 years to bring a drug through clinical trials, and yet the most important events in the timeline are not in our control. We may have hundreds of offices in dozens of office buildings, and yet the most important office is not on our campus.

The missing pieces in each case are our Sites, without whom no clinical research is possible. Some biopharma research departments with an inkling of this problem have cited “Site satisfaction” as a strategic goal by. But in fact, almost all sponsors find a way to consistently aggravate our critical partners – to bite the hand that feeds us the information we cannot live without. One particular way we aggravate Sites is by demanding they use underperforming technologies which we are ill-prepared to support.

While we know that a happy Site, like a happy employee, is more likely to recruit faster and more correctly, record data more accurately and on time, and think more favorably about the trial Sponsor, most sponsors do not consider the Site as a seamless extension of the clinical trial workflow. If we did, we would be involving them in each step of the process we follow in evaluating, selecting, designing, implementing and supporting site-based technology tools.

It’s not about clever

What do we give our Sites of more lasting memory that our logo’ed paperweights at the Investigator Meeting? We give them mistrust and hostile contracting. We try to be clever in our contracting and our patient volunteer advertising. Meanwhile we take the Sites’ nurses and phone lines away. We pressure them to perform, without the support to enable them to succeed. We make them use our flawed software tools, and fail to train them properly. In sum, we make them make up for our poor management. We dwell on the negative (chronic under-enrollment and dirty data) without regard to how what we do as sponsors directly affects Site performance.

It’s about trial management excellence
Trial management excellence includes a number of important components, including building close professional relationships with principal investigators, communicating our plan and delivering on what we promised, creating a service orientation toward our Sites, and ensuring the tools that support these actions (EDC, CTMS, IVRS, ePRO, etc.) are helpful and not burdensome. Let’s look at several of these items and how technology can and cannot support Site Satisfaction.

Relate Locally
While we often spend long hours, appropriately so, trying to improve our ability to manage globally, what we mostly fail to do is relate to our Sites locally – to build an effective and knowledgeable personal relationship. Several biopharmas are beginning to speak about “territory management” as a task of their regional monitoring networks. This term, borrowed from salesforce management, represents an excellent concept: regional monitors should get to know the physician pool in their region, to be proactive in identifying potential future investigators. Even if they get to know specialists in areas they don’t “need” yet, you never know when your company will enter that therapeutic area, and these physicians can refer them to others they can use now.

Another term borrowed from salesforce management is more unfortunate: “IRM” (Investigator Relationship Management). This phrase is adapted from “CRM” (Customer Relationship Management) and refers as much to technology used for this purpose as it does to a strategic operational concept. While the metaphor of IRM to CRM is superficially useful, it is another clever idea taken too much to heart. The key to “IRM” is an intelligent human connection, not a new database tool. As soon as technology enters the picture (and of course there is a place for it), the tendency is to rely on the tool and forget the human connection. IRM, as a technology, in practice ends up objectifying the Site and further mechanizing what should be a personal relationship. To be effective, IRM technology needs to be subservient, even invisible, to the effort of sponsors to build effective, creative Site relationships.

Professionally Manage the Trial
Trial management skills across the industry are modest at best. One key to Site Satisfaction is to demonstrate professionalism in the timeliness of achieving milestones and responding to issues. Another is to minimize those protocol amendments! Both of these objectives can be helped or hurt by technology, depending on how we use it.

A CTMS (Clinical Trial Management System) can be used to greatly assist the trial manager in understanding trial progress and problems, and in timely communication with the Site. But many “CTMS” applications are focused completely inward, on what the biopharma enterprise needs, without including the Site’s needs in the equation. A CTMS, or other application, which provides immediate and direct access by Site personnel to critical trial conduct data, and which is easy for the Site to use to supply information to the sponsor, is truly enabling of trial management excellence.

Similarly, the best goodwill created between Site and sponsor, over time, by repeated use of EDC, is consistently undermined by the annoyance of repeated protocol amendments. These changes have always been irritating to Sites, expensive to sponsors, and often avoidable. When using EDC, the amendment is additionally annoying. This is how good trial practice is directly related to the Site’s perception of the technology they are required to use.

Provide Tools that Work
Too often, we inflict, rather than empower, our Sites with technology tools. We select these tools totally without regard or consultation with Sites, choose vendors because of price or through suboptimal selection processes, and then send the software out to the Sites and good luck to ¡®em. Clinical Operations staff (those directly interacting with our Sites) also often feel as if they are a victim of information technology, something inflicted on them from the CDM or IT department, or from an individual executive who leaves the implementation to others. In both cases, the fault lies in software tools being driven by those furthest away from the point of use (Sites and monitors). Reverse that fact and application quality (and Site satisfaction) will rise.

All parties – sponsor side and Site side – also can be victims of the software vendors. Despite the fact that it is 2005 and the third-party clinical research software industry is now 20 years old, we still find some vendors who are quite unprepared for the responsibilities of supporting clinical research, including providing knowledgeable and timely support, software that is predictable and reliable, tools that provide some benefit for the lowest level user, and applications that are scalable to our ever-expanding trial load and complexity.

Create a Service Orientation
A fourth key element of trial management excellence, and thereby Site Satisfaction, is for Clinical Operations and Data Management groups to have a service mentality toward Sites. We need to think of the Site as our customer, someone we serve instead of someone we berate. This single, yet dramatic change of thought, would be a remarkable exercise for our organizations to go through. What we have decided is important or critical in our daily work would change dramatically. A customer service orientation, for instance, would never allow a data cleaning process that helped our backoffice offshore entry clerks, but interfered with a study coordinator trying to get through her clinic day.

These shortcomings in how we employ technology, rather than the functions and features of the software, are the key to trial management excellence, and to satisfying instead of aggravating our Sites. Sites are critical to the success of our trials, but we treat them like vendors instead of scientific partners. While there are many poor Sites, there are an equal proportion of poor sponsor trial managers. Trial management excellence, and the properly designed and supported technology tools to support excellence, will ensure we don’t go hungry biting the hands that feed us mission-critical patient experience.

Ronald S. Waife is President of Waife & Associates, Inc. and can be reached at ronwaife@waife.com or +1 (781) 449-7032.