OUTSOURCING
“Clinical operations folks don’t necessarily think about the broader business and its impact. We serve as gatekeepers against risk and liability.”
which led me to Genentech. I’ve worked with large, mid-size and small biotechs negotiating various clinical contracts, etc. In my current role, my team supports a clinical operations group in their outsourcing activities, including vendor selection, contracting negotiations, budget, and escalations around deliverables, and I like to think of my group as the business operations centre of clinical operations. Generally, clinical operations folks are consumed with timelines and deliverables but they don’t necessarily think about the broader business and its impact. We serve the company as one of the gatekeepers against risk and liability. We can be the seat of unity and uniformity across different programmes by sharing information about vendors in the space and preferred partners, and linking these aspects together.
How do all the teams work together to determine your vendor needs? Currently, my group sits in clinical operations, but we collaborate closely with procurement. Clinical outsourcing can serve as a partner in developing a strategy for outsourcing needs. In addition to service agreements, teams may need other items in support of the clinical trial. For example, a team needed stopwatches for distribution to over one hundred sites. Working with procurement, we were able to identify a vendor that could acquire and manage shipment to all sites, instead of the team attempting to do so themselves. The basis of every business relationship is a
Can you tell us about your background in clinical trials? I’ve been in the industry just a little over 10 years; I started out on the institutional side, then moved to the sponsor side, negotiating global agreements for Merck. An opportunity to work with a small start-up brought me to the West Coast, negotiating clinical trials agreements with the sites. Because it was a small company, I was able to learn vendor contract negotiation,
contract, so in the clinical space, it helps to know the vendors in a particular space and have some experience with their work or at the least some knowledge of their process. If someone on Programme A is working for Programme B, and Programme B has a similar service, rather than look at someone new, we look at our relationship with Programme A. They’ve gone through the audit process, so it’s about being strategic with your decisions.
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