Transitioning a mid-sized device company to an FSP model

ICON was contracted to support the transition of a mid-sized device company from use of a staffing company and full service CRO models to use ICON's global Functional Service Provision (FSP) model. The client’s organisational structure consisted of multiple divisions and across the divisions there were multiple providers and models being utilised. The client was challenged with the varying models of staffing and program execution within the business units and was looking to partner with a new provider to support their move into a new model to address the following: current high operating costs in staff and full-service models, opportunity for partner’s operational expertise on sharing resources between studies, ensuring long term FTEs by not having to limit time contactors were employed, and identifying a stronger pool of candidates across the organisation. ICON was able to provide a solution with ICON being the sole FSP provider for the client across the divisions.

ICON provided a global support team to partner with the client to provide clinical operations and biometrics FSP resources services. We provided a number of solutions:

Dedicated leadership and relationship management: A Global Lead, Regional Directors and Regional Managers were aligned with this client to support and drive the initiation and execution of the program. Partnership documents including a Relationship Management Plan and RACI were collaboratively created with the client to support the developing partnership processes and expectations.

Talent attraction strategy: Urgent roles were pre-recruited prior to Work Order execution in order to deliver services per the client timelines. FSP resources were identified both close to a local office as well as home based, dependent on the request from the client. Frequent global, regional and department meetings were held in order to ensure the correct talent pool was targeted and ICON’s ability to move quickly to hire.

Seamless systems and processes to support resource management and
training: Multiple tools were created in order to support the client in their transition between models including: onboarding checklist, timesheet reporting, finance, invoice and purchase order tracking, as well as recruitment tracking. Internal tools including interview templates, onboarding and offboarding checklists, program dashboards and footprints, resource tracking and candidate profiles for each division were created to ensure smooth management and quality delivery of the FSP resources once hired.

ICON Strategic Solutions resources also drew on the robust training programs provided internally to further support this client. Each Clinical Operations role was enrolled in ICON’s Medical Device University as part of their onboarding program in order to ensure they were up to date with the most recent regulations and expectations.

Communication & Governance: Frequent communication through regularly scheduled meetings and ad hoc meetings regarding onboarding and performance feedback were held to ensure a mindset of continual refinement of processes both by ICON and the client. A governance structure and issue escalation pathway were created to further support the client/partnership including quarterly Operational Management Team meetings and bi-annual Executive Oversight Committee to ensure clear goals and achievements for the partnership.
 

Through effective communication and flexibility, ICON and the client were able to effectively recruit based on the client timelines, hire and onboard 25 global embedded resources in approximately 4 months across Clinical Operations and Biometrics. The program has grown to approximately 35 global Clinical Operations FSP resources and 5 global Biometrics FSP resources to date. Additionally, ICON maintained all internal metrics for the partnership at the threshold or higher. ICON was able to support the client’s internal system gaps during the transition of their model through providing the needed reporting and support. The partnership continues to grow across roles and departments with the client, with a 20% promotion rate of Clinical Operations resources. Utilisation of the ICON Medical Device University, CRA Bridge Program and CTM Bridge programs have served to counteract the lack of experienced candidates in the market and brought in fresh talent to the program.