Partnerships 2010: Mitigating Sub-Contractor Risk: How Do You Manage the Pieces of All the Moving Parts

Moderator: David L. Bartholomew, Senior Director, Contracts and Outsourcing, PFIZER
Panelists: Jay Turpen, Advisor, Clinical Project Management, ELI LILLY & COMPANY
Jon Lee, Vice President, Development Operations, CEREXA
Larry Florin, Section Director, US Clinical Outsourcing, ASTRAZENECA

A Q&A session was held that included four panel members who addressed the interaction between sponsors and vendors. The consensus was that there was no single answer in managing the risk involved in this interaction.

All of the panel members qualify their vendors by utilizing their own standardized qualification parameters. Key to managing this interaction is to develop a good working relationship with the vendor that ultimately builds trust between the partners. One panel member suggested working with other vendors to ensure fairness and equity in the vendor selection process.

Some vendors are allowed to sub-contract some of the activities while others are not. These decisions are based upon internal decisions. Regardless of whether the vendor sub-contracts or not, it typically is the responsibility of the clinical project manager to keep abreast of all activities. These are the primary individuals that are responsible for managing of these relationships as well as keeping track of vendor performance.

More primary vendors are being given more operational accountability. This is based upon the relationship that exists as well as the internal staffing that may/may not be available at the sponsor. This means that the vendor is empowered to make key decisions on behalf of the sponsor as long as the sponsor is informed as these events occur.

To ensure success working with vendors, all involved personnel are invited to attend a project kick-off meeting which typically lasts two days. All aspects of the project are discussed in detail that includes accountability and responsibility for the project. The key to working with a vendor is to spend as much time up front with each other to address any and all project related issues. Written documentation of these meetings is essential there is a dispute later in the project.

A number of metrics are employed to measure performance. Again, these are maintained by the clinical project manager and reported to the team members on a frequent basis. A very basic indicator of acceptable performance is whether the vendor receives additional work from the same sponsor. The old adage of past behavior is a good indicator of future behavior applies well to this situation.

The panel members suggested using competitive bidding or preferred vendors for multiple bids. They also encouraged vendors to use specific sub-contractors (women/minority owned companies, veterans etc.) to meet applicable government requirements, when appropriate.