By Debi Maloney
Outsourcing at least some aspects of the R&D process has become a way of life for pharmaceutical firms and, according to a report issued by Business Insights, outsourcing revenues are forecasted to rise an additional 14% to 16%, reaching $23 billion by 2010. One aspect of outsourcing that is making similar gains in growth is electronic patient-reported outcomes (ePRO) systems. These systems include electronic diaries (eDiaries) issued to each patient at the start of a study, which can have a significant effect on data accuracy and patient compliance, among other benefits. In most pharma and biotech firms, outsourcing is handled by an outsourcing director, manager, or department, whose job is to field requests from internal study teams, evaluate competing vendors, oversee a vendor selection process, negotiate the contract, and administer the vendor relationship within the organization. The direct counterpart to the outsourcing manager on the vendor side is the business development professional, whose job is to apprise the outsourcing managers of the unique benefits of their system, prepare proposals, and fulfill successful contracts. How well these two roles connect, interact, and work together can often have significant influence on how efficiently and affordably an outsourced clinical trial proceeds.
Often, these two professionals, unfortunately, will stereotype one another. For instance, when people learn I’m in sales, their guard goes up. On the other hand, it’s easy for me to start out assuming an adversarial situation where there may be none. I want the outsourcing manager to understand that I don’t want to just make a sale; I want to make a good sale, support it, and witness its success.
Michele Gause, global strategic sourcing manager for Bayer HealthCare, LLC, agrees that both she and her counterpart want a successful application of the technology, but feels it’s her department’s obligation to evaluate and choose the best solution for her company and study team from among competing proposals. “Electronic diaries started to come into play about five years ago, and they are now becoming more accepted,” she explains. “We don’t have a preferred vendor for eDiaries yet, so we’re still open to learning the benefits of a new system.”
Develop A Collaborative Relationship
Of course, in business development, communicating the benefits of your particular system is the name of the game. At CRF Health, we try to get our message to the end users and the study teams. It’s not always easy because the outsourcing manager wants to protect the study team from an onslaught of vendors. One mechanism that has worked for us is to host a lunch-and-learn where we can talk to the whole team at once and perhaps introduce some different metrics they could use. Or, if they think the system is too hard for patients to use, show them that it’s really simple.
Getting to the point where you can stage an event like a lunch-and-learn, however, does not happen without some serious relationship building. “We have a much more collaborative relationship with the vendors on our preferred listing,” Gause said. “We meet with them periodically to determine what works, what doesn’t work, and what we could do better.”
With a more trusting relationship in place, dealing with situations such as a change in the scope of a study becomes less of a trauma. If a study team needed to add, say, ten extra countries or ten extra languages to a study, we would need to negotiate with the outsourcing manager for the extra cost, but the last thing either of us wants to do is delay the study. If it means we have to buy extra units on just a handshake, well, we can do that when we have a relationship of trust.
Gause adds, “What I look for in a vendor is to be an advocate for our company with their company. When they understand our timelines and our processes, everything can run more smoothly.”
At its best, the outsourcing manager and the business development professional have a symbiotic relationship. Working together works to their mutual benefit and pays off in better integration of technology, smoother negotiations, and easier change orders. In outsourcing for clinical trials, the best business relationships are personal.
Debi Maloney is VP of corporate accounts at CRF Health (www.crfhealth.com), a provider of electronic patient-reported outcomes solutions for the life sciences industry. Ms. Maloney has over 20 years of experience in the life sciences and technology industries.