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Braided ropes

I. Introduction

Model Selection

Within the pharmaceutical industry, there are six dominant methods used to model outsourcing strategy between a sponsor company and a clinical research organization (CRO): Ad Hoc, Preferred Provider, Functional Outsourcing, In-sourcing, Sole-Provider, and Compound-based Outsourcing (Figure 1). The selection of each of these models for the outsourcing strategy is driven by various key indicators, specific to the needs of the sponsor companies. Overall costs, the need for flexibility in resources, and the access to specific expertise are critical components driving the need for outsourcing of clinical study execution, but selection of the outsourcing model itself is subject to the individual needs of the sponsor at the time of outsourcing. Various models can be selected, each with its own specific characteristics.

 
Overview of outsourcing models

The Preferred Provider model focuses on vendor consolidation and partnership relations to provide cost effectiveness. This model is mainly selected by larger pharmaceutical companies. Biotech or small pharma companies are often considered too small or not having enough studies to be outsourced to make this volume-driven partnership a viable sourcing solution. The smaller number of studies also precludes the functional outsourcing model from being viable.

The Ad hoc model can be view as more “transactional”. For instance, with the Ad hoc model, the sponsor defines scope of work and provides overall oversight. The CRO has the responsibility for executing many of the project components: from fully manages specific task(s), to providing staffing for the project, periodic updates on study progress and issues to Sponsor, and finally for developing and maintaining Risk Management Plans. The Ad Hoc model is still the most popular model due to its obvious benefits of having skilled people merely a convenient phone call away on an “as needed” versus permanent basis.

However, this Ad Hoc Outsourcing model, also referred to as a “Fee for Service Model,” contains a number of disadvantages for small or mid-size sponsors. For example, with the Ad Hoc model, available sponsor resources are often under-utilized and procedures between sponsor and CRO are insufficiently integrated. There is less insight into study activities and sponsor oversight may be limited, which results in a reduced knowledge of day-to-day matters, loss of connection to specific study related issues, and sponsor involvement in problem solving.

The drive to maintain effective sponsor oversight and optimize the use of the internal and the external resources to the maximum extent possible can be achieved by applying a hybrid outsourcing model.

The Hybrid model, which is a hybrid between insourcing and the traditional Ad Hoc model, represents a collaborative approach between the sponsor and CRO. In this model the sponsor still defines the scope of the work and CRO is responsible for the execution of the clinical study, but overall oversight of the project may be shared by both parties. Additionally, unlike the Ad hoc model, this model allows for the sharing of resources, selection CRO or Sponsor procedures or even a combination of such, and engages in daily hands-on interactions.

Foremost among the characteristics of the Hybrid model is the use of the CRO and sponsor’s resources in a collaborative setting. It is relevant for small or mid-size sponsors who have limited resources available, and need access to additional expert resources and overall infrastructure, quality system and technologies to conduct more elaborate clinical trials. Each of these key components is provided by this model. Additionally, the Hybrid model allows for a unified team approach to problem-solving, wherein the sponsor experiences site issues first-hand, can facilitate study wide improvements, and thus can be involved in real-time risk mitigation.

II. Hybrid Model Case Study

Assuming that each methodology comes with implicit strengths and weaknesses, we followed a small-sized pharmaceutical company willing to experiment with the hybrid model. The company was experienced with their compound and had the support of internal data management resources. They hired a CRO to support overall project management, vendor management, clinical monitoring, and quality system and management tools. The project structure is shown in Figure 2.

Our study identified a number of challenges that the hybrid model was able to address. For instance, we noted that the communication flow quickly becomes complex, but a detailed communication plan was implemented to alleviate any potential difficulty. Additionally, it was necessary that all information be shared in a straightforward manner. This was managed through the use of Clinical Trial Management Software (CTMS) for all monitoring activities and tracking. Moreover, the sponsor wanted to apply its own internal procedures.

This issue was resolved by integrating the SOPs of the sponsor and SGS; namely, through the creation of study-specific SOPs and cross-team SOP training on sponsor and SGS procedures.

 
Hybrid Model Case Study

III. Conclusions

Our study found the best prescribed model for optimizing sponsor-CRO relationship was a hybrid model strategy where the sponsor and the CRO worked equally together.

In order for the Hybrid model to be implemented successfully a few important points must be addressed early in the process. Both sponsor and CRO must agree on clear and concise roles and responsibilities, and all parties must be committed to integration in a common structure. Centralized, globally-accessible study management tools – such as EDC, CTMS, and SharePoint – must be used in order to allow common access to all study information. Furthermore, SOPs need to be carefully selected and implemented, and if needed combined in study-specific SOPs. Most importantly, to ensure success of this model in any clinical study there must be commitment to the hybrid structure at the highest level of management in both companies. The underlying understanding being: there is no spate sponsor team and CRO team; there is only a single, fully integrated study team.

When compared with the Ad Hoc model, the agility of the Hybrid model is apparent. The Hybrid model features the integration of the CRO with sponsor resources. It fosters a spirit of partnership and teamwork in the research being conducted. Procedures are integrated and the sponsor has daily interaction with the CRO as well as access to CRO infrastructure.

In summary, there are considerable benefits to using the hybrid model. By making use of internal resources, sponsors are able to achieve cost savings and reduce out-of-scope costs. The hybrid model also allows for a higher level of control over operations, which makes for more timely risk mitigation. With the sponsor acting in the capacity of project leader there is a greater ability to have real-time status updates for stakeholders as well as ongoing customization throughout the life-cycle of the project. Therefore, when developing an optimal hybrid outsourcing model it is important to consider all available staffing resources and tools, as well as how to create an effective hand-in-hand dynamic. Above all, it is important to remember that one size does not fit all.

 

Author

Stefan Comhaire
SGS Life Science Services Director, Clinical Operations USA – Clinical Research
Vice President Clinical Research, SGS North America, Inc.