How To Achieve Success In An FSP Relationship

By Ed Miseta, Chief Editor, Clinical Leader

Deciding to transfer responsibilities from one vendor to another in the middle of a study is something every clinical professional dreads. Laurie Callen, Director of Clinical Data Management at TESARO, an oncology-focused biopharmaceutical company, knows the feeling well. She recently had to do just that when her company sought to restructure its outsourcing model in clinical data management by entering into an FSP vendor alliance.

“We wanted to be closer to our data, but didn’t necessarily want to manage the workflow ebbs and flows,” she says. “We also didn’t want to hire a full set of contractors or in-house staff knowing that at some point they might no longer be needed. Eventually, it became obvious to us that hiring an FSP vendor to help manage the various workflows might be the best way to go.”

At the time TESARO had several ongoing studies that were large, complex, and fast-paced. The first question that occurred to Callen was how to manage the move. She knew she would need experts to help her with the transition, so TESARO selected a vendor that specialized in data systems and immediately sought to create a relationship that would benefit both companies.   

The next thing TESARO did was to form FAST, its Functional Alliance and Strategy Team. FAST was a small group of leaders from both companies working together to determine the status of the studies, the tasks that had been performed, and the tasks that still needed to be performed. The team then had to prioritize tasks for the short-term versus the ensuing weeks and months.

 Evaluate The Current Structure

To ensure there was an alignment of expectations on both sides, Callen took some time at the initial meetings to express her needs and determine if they could, in fact, be met. Because FAST consisted of a small number of members, communication was efficient and they were able to work through all of the tasks and milestones quickly. She was also able to understand the needs of her vendor. The analysis and assessment were completed in just two weeks. In working with the FSP vendor, Callen was able to customize the team and define what skill sets and resource levels were needed.

“For example, we knew we would need a suite of data management or data analysis leads – individuals who could manage the status of the study,” notes Callen. “But we also needed experts who understood how we work with central and local laboratory data. They understood that at certain times we may need two of them and at other times we might want five of them. Based on the milestones and the fluctuation of the data, we could identify when those skill sets would be needed.”

Get Needed Outputs In Place

There were certain things Callen knew would have to be put in place to make the partnership a success, since they would lead and govern all goals going forward. Some were identified early on in the process. Once goals were set, others were enabled farther on down the line. The first output that she knew would be required was a service level agreement.

“For an FSP vendor, the agreement is different than usual because we were not looking at an output or task completion,” she says. “We were really looking for a skill set of resources. Therefore, in the service level agreement, we identified that we would need a suite of various skilled resources. Those were perhaps leads or project managers…those who had various skill sets for medical coding or serious adverse event reconciliation, for example.”  

Callen notes the service level agreement (SLA) and the resource projection play hand-in-hand. An implementation plan was also needed, which she notes is really the governing structure for the original handoff, covering the who, what, where, when, and how. It was very specific on details, noting who was doing specific tasks, who would manage them, and what the timeline would be for task completion.

“This is one of our more flexible plans,” she says. “We meet, review, and readdress to ensure we understand all of the various handoffs. A more customized approach was used to determine how to handle resources and accomplishing key milestones. A project management plan noted the timelines and cost structure that would be needed and/or the estimates that were put in place.”

Quality Is A Key Concern

One of the most important documents was the quality agreement, which Callen states was at the heart of why TESARO performed the transition. “We wanted to have a closer handle on quality of the data and the quality tasks that were actually performed. We also wanted more control over the specific skill sets that would be assigned to each of the studies.”

From the quality agreement, TESARO established various definitions of how personnel would evaluate quality through metrics, KPIs, and communication pathways. A system was also enabled that would dictate a training and QC level for each of the various tasks. The idea was to apply resources to a suite of studies with processes and standards denoting how to perform certain tasks.

It took another three to four weeks to finalize the creation of all the additional plans noting how the two companies would work together. By the time work was launched on the first suite of studies, there was an alignment of needs and goals.

Soon after activities commenced, a multi-tiered governance structure was launched, which would ensure frequent communication between the teams. Initially weekly conversation points were established between data leads, project leads, and project management leads. In reality, conversations happened even more often because of the flexibility that existed with the vendor relationship in the FSP model. Team members were able to meet as often as they liked, which sometimes occurred daily. Callen notes some of the key components that were established early on were the result of having frequent communication.

Steering Towards Success

So how do you perform all of these tasks and still ensure everything is in alignment and that success will be guaranteed for each other? TESARO used a broadcast communication and information update strategy. The company would host communication information strategy updates and distribute them to every resource needing to see them. Checks were conducted to ensure recent communications were reviewed and understood. A lessons learned and decisions log were also maintained and reviewed at the weekly meetings.

A steering committee was also put in place, and both companies agreed to include VPs to guarantee knowledge of all the details would reach the highest levels in the organizations. The steering committee involved other levels of management based on the agenda for the meeting or the specific needs at various times. This was easy to do since the agendas were prepared in advance of the meetings and distributed to appropriate individuals. Initially the meetings were monthly but were later switched to quarterly as the relationship grew and the companies became comfortable with each other.  

“During steering committee meetings we would perform an overview of our metrics and KPIs at the highest levels to ensure we were meeting our agreements,” says Callen. “Financial oversight was also performed to see if we were staying true to our expectations and projections, which was vital to the success of both companies. A key component was reviewing those lessons learned to determine where we could avoid issues, rather than having them happen and then having to resolve them.”

Reflecting Back On Takeaways

Callen does not regret the move to a vendor FSP relationship and feels there were three major takeaways from the experience. First, the relationship enabled TESARO to have direct daily oversight of operations and truly work with a partner that was an extension of the TESARO team. This enabled productivity and quality to be managed jointly between the two companies.

Second, high-level individuals from both companies met regularly to understand the goals, ensure they were being accomplished, and guarantee the venture would be successful for both partners. At the end of the study, both companies felt they benefitted from the relationship.

Finally, there was a high level of transparency throughout the studies. Transparency was pushed at all steering committee meetings where involved personnel were encouraged to put every pertinent issue on the table, even if it meant feelings might get hurt in the ensuing discussion. Both sides were committed to making sure there were no elephants in the room not being discussed.  

‘We were able to customize the needs of the trial, the needs of TESARO, the needs of our future portfolio, and the needs of our vendor,” adds Calen. “By customizing what the vendor was able to provide to us, we were also able to understand what they could do for us with in the future. This helped us understand how we could better use their assets, which will lead to more successful trials and greater success for both companies going forward.”