Functional Service Provider (FSP) relationships are becoming more commonplace within the Pharmaceutical Industry. The aim of such a relationship is a jointly beneficial commercial and financial model which will continually drive improvements in quality and maximise efficiencies and value for the customer. Collaboration is often defined by company and business goals which can be changeable, and has flexibility to evolve as the business develops which strengthens relationships further.
Whether you are looking from the view-point of a Contract Research Organisation (CRO) or Sponsor Company, there are key considerations to take into account when progressing with an FSP relationship. Some of the fundamental elements have been described below.
- Portfolio – A portfolio will provide detail on the forthcoming workload for a particular company and is always driven by business goals. The information will form the basis on which an FSP relationship is shaped and will influence the overall timescale of the proposed collaboration, as well as enabling the predicting of resource needs. It is beneficial to consider including a measure of probability for study occurrence and ensure necessary risk adjustment to resource is taken into account.
- Resourcing Models – FSP resourcing is based on the company portfolio and the pre-agreed outsourced functions or activities. With this information it becomes easier to determine the most effective resourcing model for a particular opportunity; taking into account staff integration with Customer teams on site, multi-region support and global expertise will optimise cost structures.
- Governance and Metrics – A governance structure may be developed to provide strategic and operational oversight of all activities within the FSP relationship. Determine the requirement for cross-company governance at the strategic, financial and operational levels as required. Look into areas such as risk assessment and performance metrics that you may wish to implement, be they cycle time, efficiency, timeliness or quality; focus on the practicalities of collection, reporting, review and action on these metrics.
- Communication and Escalation – Ensure that communication is streamlined across the relationship. It is often beneficial to generate a Communication Plan to detail the communication charter, expectations of the team, escalation pathways and to reference a team contact list. This may also be generated at the individual study level as necessary.
- Financial Management – Establish the most appropriate costing model for a relationship based on the strategic factors already advised and ensure that the management of changes in scope is clearly defined in relation to this.
- Process and Standards – Operational alignment is key to seamless integration of team members within an FSP relationship. Ideally, document clear delineation of roles and responsibilities across all parties, implementing a Task Ownership Matrix (TOM) and/or Responsibility Assignment document (RACI) that is agreed and accessible to all. Determine the Standard Operating Procedures to be used and perform a gap analysis to identify any potential areas of risk and associated mitigation. Agree data standards to be implemented across the portfolio of work, taking into account any third party data providers.
- Technology – Technology is of great importance when aligning operations, from performing basic communications via Instant Messenger, email or internet phones; creating a central document repository for sharing and approving key study documentation; through to implementation and maintenance of CDMS or CTMS. Such technologies need to be agreed up front, as do responsibilities for areas including ownership, maintenance, security, end user support and licencing.
- Training – With key processes and technologies agreed it may be necessary to focus on specific training for individuals being brought into the relationship. Training may range from SOP reading, completing eLearning modules, reviewing documents or attending instructor led courses, and could be provided by either partner. It is possible to align a training matrix with the RACI document to ensure complete coverage of activities, which will also ensure consistency following update of either document.
In summary, by taking these fundamental elements into account you may confidently initiate discussions relating to the creation and maintenance of a successful Functional Service Provider relationship within your company.
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