Valuable time wasted explaining basic life sciences concepts. Substandard work that needs redoing. Poor communications and poorer results—leading to endless clinical trial delays and contracts of dubious validity.
The damage caused by outsourcing legal work to a low-quality, inexperienced vendor can be enough to make sponsors shy away from this practice for good. As a result, many sponsors are considering a return to traditional ways of working—hiring in-house legal counsel. But is this move viable in the long-term? Or will the shift remind sponsors why they turned to outsourcing in the first place?
One advocate for high quality outsourced legal work is Colleen Sproul, the President and CEO of Contracts Associates, Inc. Her company’s mission is to deliver the expertise and experience of in-house counsel combined with the agility and responsiveness of an outsourced vendor. She founded the company in 2006 in response to a significant gap in the clinical trial process that she knew she could fill.
“Sponsors were typically taking on recent law school grads or temps from staffing agencies to review their clinical trial contracts,” Colleen says. “I saw an opportunity to draw on my own prior in-house experience to provide sponsors with expert, expedited contract review on an as-needed basis so that their clinical trials could get up and running on time and with the proper protections in place.”
Colleen’s team comes in with the on-point biotech and pharmaceutical experience required to hit the ground running. In fact, extensive life sciences experience is a prerequisite for joining her team of attorneys. In contrast, temp attorneys and fresh-faced law grads frequently struggled to grasp the ins-and-outs of the clinical trial process—opening the door to inefficiencies, careless mistakes, work needing to be redone, and long, laborious explanations.
So why had sponsors started outsourcing in the first place? At the time, many assumed it would allow them to sidestep the higher long-term costs associated with hiring an in-house team.
“Hiring a new employee is a serious investment,” explains Colleen. “The recruiting and onboarding process is time-consuming and involves substantial resources. Training is intensive. The compensation package for top talent is often significant. Especially for short-term studies, it makes no sense to go through all this effort only to lay off the employee in a year when the study is over.”
This was the problem Colleen set out to solve by forming Contracts Associates. As an attorney with vast biopharma experience, she sought to offer a cost-effective solution that delivered all the benefits of an in-house legal team without any of the drawbacks.
In-house counsel, for example, will frequently find themselves bogged down by other responsibilities and competing deadlines, leading to delays. But an outsourced vendor can dedicate all their time and energy to expediting the contract review process and clearing backlogs.
Colleen took this one step further. From the very beginning, she chose to keep her company virtual, giving her team the freedom to work flexible hours dependent on their clients’ needs.
“By having my team work remotely, I’m able to recruit top talent no matter where they are geographically located,” she says. “We aren’t constrained by a typical workday. We routinely communicate with clients and clinical sites all over the world, and we can meet deadlines for clients in the EU or Asia as easily as we do in Boston.”
Since outsourced solutions were designed specifically to help sponsors avoid the unnecessary expense and difficulty of building an in-house team, Colleen views the recent trend toward in-sourcing staff as a step in the wrong direction—and one which could be costly. Rigid and outdated, this approach can never offer the same versatility and responsiveness that outsourced teams like Colleen’s can deliver.
So how can sponsors be sure they’re working with a vendor that will deliver the exacting standards they require? Colleen has some advice.
“I’d recommend looking for an established company with demonstrable experience and expertise in the life sciences,” she says. “Look for depth and breadth of in-house experience among the team. A company should be responsive and demonstrate clarity and confidence in their turnaround times.”
Ultimately, outsourced solutions can offer the same expertise as in-house counsel with the added agility sponsors need to meet their milestones and get their clinical trials off the ground. Since these solutions are available on an as-needed basis, they avoid the restrictiveness of long-term hiring. By taking the time to research a vendor first, sponsors can avoid facing problems down the line.
“Our company is dedicated to handling contract reviews—it’s what we do,” Colleen says. “We’re like hired guns for the pharmaceutical and biotech industry!”
To learn more about Contracts Associates or for advice about expediting your contract review process, get in touch today.