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International Clinical Trials

Pick and Choose

Functional service provider (FSP) partnerships have been gaining traction in recent years because of their potential to increase efficiency and flexibility in outsourcing without compromising quality. Well-defined services within the scope of a clinical trial project or programme – for example, data management, biostatistics or medical writing – are good candidates for FSP outsourcing.

By outsourcing individual functional services, sponsor companies can gain freedom they might not have through a traditional preferred provider relationship or when outsourcing an entire study. Many factors contribute to a successful FSP relationship – and when evaluating contract research organistions (CROs) as potential FSP partners, sponsors should look for certain qualities to ensure they choose the right one for their needs.

FSP versus Full Service

To fully understand how best to evaluate CROs for these partnerships, one must understand the difference between FSP and full-service outsourcing. Traditionally, sponsor companies have outsourced full-service responsibilities to CROs for their clinical trial projects or programmes, often within the scope of a preferred provider relationship. In this scenario, individual CROs manage the entirety of a clinical trial.

Recently, however, sponsor companies have moved away from the rigidity of a preferred provider, full-service relationship towards the ‘cafeteria-style’ of outsourcing, which an FSP relationship represents. In this model, sponsors can pick and choose which services to outsource to which CROs. This allows them the flexibility to select the best CROs for each service area and develop long-term relationships that make sense for each individual area. The following tips should help companies choose the best FSP partner for a programme’s needs.

Cultural Fit

The benefits of FSP partnerships are not realised overnight. Instead, these benefits come from the formation of a strong relationship between sponsor and CRO that often lasts for years. This is why identifying a CRO that is a good ‘fit’ for the sponsor organisation and programme is imperative. Start the vetting process by asking about company values, how conflicts are resolved, communication channels, management oversight and approach to customer service. The CRO’s answers to these questions should be in alignment with the sponsor’s approach to clinical research and collaboration.

CRO Experience

There is no substitute for experience in the clinical research industry – the stakes are high and the need for high-quality deliverables is critical. CROs that have maintained long-term, successful FSP relationships with other clients are better positioned to develop future successful FSP partnerships. They are more likely to have worked out the kinks, and will be able to hit the ground running with a new sponsor.

An experienced CRO will understand that their team needs to be a true extension of the sponsor’s team, and they will want to understand sponsor systems, processes and expectations from the start. Experienced CROs will also have recommendations for training programmes, which will help ensure a seamless integration between CRO and sponsor staff, and enable new staff to be trained quickly and efficiently.

Finally, experienced CROs will provide recommendations for the best way to work together, including overall programme management, rapid start-up processes, points of contact, system usage, process development, deliverable and timeline tracking, and billing.

Team Consistency

Successful FSP partnerships require a level of team consistency that some CROs are not able to provide. Having CRO team members that possess historic and long-term knowledge of the programme can significantly increase efficiency and reduce administrative costs, such as oversight and training.

Sponsors should ask potential CRO partners about company and team turnover rates. They should also ask potential partners about their strategy for maintaining and disseminating programme-related knowledge across their team – for example, therapeutic, protocol and system knowledge – as well as how they handle team member departure/reassignment and on-boarding.

None of these should be passing thoughts; instead, these strategies should be part of the foundation of the FSP partnership, and CROs should have past experience to bolster their proposed strategies. In addition to ensuring the quality of deliverables, maintaining a high level of team consistency will ensure efficiencies are maximised.

Flexibility and Scalability

One of the major benefits of an FSP relationship is the ability for the CRO to provide resources in a flexible and scalable manner. Sponsors should ask the CROs about how they plan for and handle the need to scale up quickly, as well as how they avoid under-utilising resources. In both cases, some sort of strategic forecasting and proactive communication should be part of their plan.

Programme governance meetings are an excellent means of managing the resourcing demands of a successful FSP partnership. These meetings can occur as often as necessary to ensure constant communication between CRO and sponsor. Both parties should contribute to the agenda to ensure active engagement. These meetings can be beneficial in maintaining a ‘big picture’ view of the partnership, and they encourage direct and frequent bi-directional communication between team members.

Winning Formula

Choosing a CRO that has FSP experience, team consistency, a clear approach to flexibility and scalability and is a good cultural fit is the first step toward establishing an FSP relationship that has the potential to reduce time and costs without compromising scientific integrity or quality.

There are many CROs in the industry which provide FSP services, so it is necessary to conduct a thorough evaluation to identify a partner which is a good match for the clinical trial project or programme. In an industry where the goal is to get approvable drugs to market as quickly as possible, consistency in all of these areas is a winning formula for identifying an FSP partner that a sponsor can trust.

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Dawn Edgerton is Assistant Vice President, Operations, at Rho, a full-service CRO. She has 16 years of experience supporting research within the drug development industry and National Institutes of Health longitudinal studies. In her current role, Dawn provides leadership and guidance to project leads across all phases of clinical development and over a wide range of therapeutic areas. Her primary responsibility is ensuring customer expectations are met with respect to cost, quality and time, while ensuring profi tability for Rho. Dawn holds an MBA with dual concentrations in Services and BioSciences Management, as well as US Regulatory Affairs Certification.
Dawn Edgerton
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