A Functional Service Provider (FSP) offers a variety of clinical trial services on an “a-la-carte” type basis – as opposed to a full suite of services. This allows large Pharmaceutical companies to outsource only what they need to fit their budget (and other factors).

This blog article discusses how a COLLABORATIVE APPROACH to understanding the clients? needs and GOOD LISTENING SKILLS on the part of the service provider, make offering a partial selection of services (as opposed a full suite of services) a practical and cost effective approach to pharmaceutical drug development in this economic climate.

As more and more pharmaceutical companies are outsourcing the management of clinical trials to Functional Service Providers (FSPs) there is a need for constant and competent communication between the Sponsor and the FSP?s who are providing specific clinical trial services.? This is not something to take for granted as communication will be the key to a successful project. The pharmaceutical company owns the project, while the FSP manages some aspect of it. Although a solid contract that is legally binding is always negotiated between the pharmaceutical company and the FSP, both entities will find that a good working relationship depends on open communication and collaboration.

Collaboration is a Must
Collaboration simply means working together to create something new. There are many different ways that the management of clinical trials can be outsourced to FSPs, but all require collaboration between at least two entities. The involved companies must have a shared plan as well as the right people and tools to work on the project.

When pharmaceutical companies outsource clinical trials, even though they still own the project, they must work together with the FSP. In fact, a pharmaceutical company may outsource different parts of a project to different FSPs. In order to create a satisfactory end product, they must all collaborate and set up parameters to delineate which entity is responsible for which tasks. In addition to emails, telephone calls and regular reporting, face-to-face meetings must be part of the collaboration process.

Need for Clear and Constant Communications
Collaboration requires clear communication. Just some aspects of the FSP agreement that must be communicated include:

• The agreement may include the temporary transfer of certain employees knowledgeable about the project to temporarily work with the FSP. This limits the need for new workers to spend time and money to familiarize themselves with the project. When this happens, clear communication with the employees is imperative so they know who is in charge and what the expectations are for everyone on the project. This will relieve the FSP of potential personnel problems and concerns.
• Plan in advance for contingencies. Anticipate potential problems during the management of clinical trials and establish protocol as to how those problems will be solved. For example, what happens if there is a lull in the workload at the FSP due to a glitch at the pharmaceutical company?
• The FSP and pharmaceutical company need to agree on the vision for the project to be sure they are both on the same page headed for the same goal.
• If the project is confidential, this needs to be clearly communicated to the FSP and all employees who will be working on the project.

Need for listening skills
As basic as it seems, communication and collaboration involve listening. When one entity owns the project and the other entity is the chosen vendor for outsourcing, conflict is not uncommon. Experience has shown that while the formal contract outlines the responsibilities of the entities and governs who has the authority, the key to the success of the project is the ongoing communication and the willingness of each entity to listen to the concerns of the other. It is this active communicative relationship that guarantees the ultimate success of the project.

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