Cami Stewart-Myers has been at the forefront of delivering functional service provider (FSP) collaborations for two decades. An employee of PPD FSP Solutions for over 18 years, her experience to date has entailed working at investigator sites, clinical monitoring management of clinical teams, and working as an operations delivery lead, as well as an implementation lead.
It is this latter role which forms the crux of today’s conversation with Fierce Biotech’s Julia Douthart.
“PPD made the decision years ago that, for key partners when the volume of work is significant, we would adopt an implementation lead in order to best prepare the partnership for operational delivery,” she explains.
“This person is a dedicated resource that works with the core team members in the beginning of the client-PPD relationship to lead and oversee development of the infrastructure of the partnership.”
With their breadth and depth of expertise, the implementation lead ensures projects are delivered on time. The implementation lead works closely with the implementation team to seamlessly fulfill project scopes and reduce overall timelines.
One of the crucial functions of implementation leads, Cami says, is to identify and remedy bottlenecks that may occur across the lifespan of a partnership. These include identifying and placing resources typically under a tight timeline, delays in finalization of the partnership contract, and issues around IT, including integration systems and equipment challenges.
Julia Douthart: I am Julia Douthart with Fierce Biotech, and today we're speaking with Cami Stewart-Myers, associate Director Project Management for PPD FSP Solutions. Cami, welcome.
Cami Stewart-Myers: Thank you so much. Nice to be here.
Julia Douthart: To get us started, can you tell us a little bit about yourself and your role at PPD FSP Solutions?
Cami Stewart-Myers: So, as you said, my name's Cami Myers and I am an operations delivery lead with PPD, oftentimes also acting as an implementation lead, working within the PPD FSP group. So just to give you a little bit of history about myself, I've been with PPD for 18 years. My experience spans across working at investigator sites clinical monitoring management of clinical teams, working as an operations delivery lead, as well as an implementation lead. So the role of the implementation lead is what really allows me to apply my broad experience into my daily work life.
Julia Douthart: Can you give us a brief overview of the functional service provider model within PPD?
Cami Stewart-Myers: So, people tend to have some difficulty differentiating FSO from FSP. So, if we look at it like a house, it helps us to understand what FSP is, a little bit better. In FSO, a developer would come to PPD and ask us to build a house and we would build that house for them end to end the same as if we would run a study for a client from beginning to end. So, in FSP, a developer may come to PPD and ask us to do all the electrical work within that house that's already built. So the same as if we would perform all data management across all studies for that client. So essentially FSP solutions is not a one size fits all type of approach, and we do have a lot of flexibility to consider whatever the client's needs are. So what can we do? We can provide a full suite of services across an entire book of work as opposed to working study by study like they do in FSO. We provide dedicated resources that work the client's systems and processes. We can offer non-traditional roles and functions and we can work with all contracting types ranging anywhere from FTE based unitized time and materials output or performance-based and fixed price.
Julia Douthart: Can you tell us a bit more about the implementation leads? Where do they fit into the program timeline and structure?
Cami Stewart-Myers: PPD made the decision years ago that for key partners when the volume of work is significant, we would adopt an implementation lead in order to best prepare the partnership for operational delivery. So, this person is a dedicated resource that works with the core team members in the beginning of the client PPD relationship to lead and oversee development of the infrastructure of the partnership. The implementation lead works very closely with the operations delivery lead to ensure the partnerships foundation is set up to their expectations and ensure a seamless handover when the implementation phase is completed. So if you had noticed in my introduction, I introduced myself as an operations delivery lead. So, we can function as ODLs, but also serve as implementation leads. So that's important because that means your implementation lead has a good grasp of oversight of the partnership. Also having the background as an ODL.
So, the ODL is the PPD professional who has full program oversight, management of finances and key performance indicators. They're the escalation point and oversees the overall health of the partnership. So some of the implementation lead work includes overseeing resource forecasting, overseeing capacity management, a development of process documents, which would include the implementation plan and the RACI task matrix, as well as a global operations manual. They oversee training and onboarding, including a harmonized checklist that is aligned with the client they support with information technology, equipment and systems as I had talked about previously. They also oversee establishing the governance structure and rolling that out to the team and leading collaboration sessions or work streams when needed. So the implementation lead works closely with an implementation team that's made up of talent acquisitions, human resourcing, quality finance, information technology and resourcing and capacity management. The significant contributions of the implementation lead occur upfront during the planning stage prior to the partnership award. As a result, the involvement of the implementation lead and the overall project scope contributes to a seamless implementation and reduced timelines.
Julia Douthart: What are the main benefits of using an implementation lead in a clinical research project?
Cami Stewart-Myers: So, as I see it, there are many benefits of utilizing the implementation lead, especially on a new partnership. They serve so many functions and they're basically like the conductor and acquire, leading and directing each player down the right path. So essentially they set up this solid foundation to get the partnership kicked off. They ensure a rapid startup and on-time delivery drive and encourage proactive communication. We see greater continuity and efficiencies in partnerships that start out with an implementation lead as well as rapid deployment and onboarding. So the implementation lead rapidly launches engagement drives fast and easy onboarding and provides proactive high touch communications, allowing to avoid startup delays, ensuring a smooth transition and meeting timelines and budget commitments.
Julia Douthart: What kind of bottlenecks are commonly encountered in the early stages of a partnership?
Cami Stewart-Myers: Several challenges that can be anticipated as an implementation lead across a partnership. I think being able to proactively identify these challenges is what really demonstrates excellence in the role. So three bottlenecks that come to mind when I think about setting up the foundation of a new partnership. The first one, and I think a lot of people will be very familiar with this, is identifying and placing resources typically under a tight timeline. So, we at PPD try to avoid this by ensuring the resourcing and talent acquisitions teams are brought on board prior to award of the partnership. This way they can begin strategizing their approach to ensure on-time resource placement with the support of the implementation lead. The second bottleneck that comes to mind would be delays in finalization of the partnership contract. Again, I think something that a lot of us are familiar with experiencing.
So, a dedicated implementation lead can drive review negotiations and finalization of the contract to ensure that if there are any delays, they're minimal. And then the third bottleneck that I can think of would be around information technology, including integration systems and equipment challenges. This is a big thing within FSP, we ensure that our IT experts are assigned to the partnership as early as possible. And with the implementation lead driving this, they assist with coordination of IT equipment and processes, oftentimes transitioning resources into the client systems. IT specializes in hardware procurement, software access, and data systems transfer or integration. So, in FSP, we have the ability to be flexible with the client's needs in regard to information technology. We can utilize the client's equipment and systems; we can utilize our own or we could take a hybrid approach. We have done all three approaches successfully and can really tailor to what the client needs in that regard. So ultimately being able to anticipate the challenges in the front-end help avoid delays further down the road. In my experience, one of the best ways to mitigate anticipated challenges is through transparent communication with the internal team and with the client. The ability to anticipate these challenges while keeping an open line of communication across the program is critical to the success of an FSP partnership.
Julia Douthart: How does PPD FSP ensure a seamless handoff from the implementation leads to operation delivery leads?
Cami Stewart-Myers: The implementation lead will be coordinating efforts with the ODL as soon as the ODL is brought onto the partnership. The implementation lead will ensure that the foundation of the partnership is structured up to the ODL standards and expectations. The implementation lead and ODL will determine together when the appropriate time is for handover. So there could be several scenarios that trigger the beginning of a handover, ranging from resourcing fulfillment to completion of collaboration sessions or work streams. It just really depends. So the final handovers will not be completed until both the implementation lead and the ODL feel comfortable that all the implementation tasks are completed and the ODL is brought fully up to speed. So the implementation lead could potentially stay on longer if continued support is needed with collaboration sessions, for example. So as I stated earlier, it's not really a one size fits all approach, but rather catered specifically to the needs of that particular partnership.
Julia Douthart: Cami Stewart-Myers, thank you for joining us today.
Cami Stewart-Myers: Thank you so much.