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How can well-trained field clinical research monitors be optimised to become a real asset to study sites and trial sponsors? Pfizer’s Anick Duchesne offers her vision
Learning how to ‘think outside of the box’ and explore the ways in which the role of well-trained and motivated field clinical research monitors could be optimised is by no mean simple. However, this process allows such professionals to break out of the standardised and self-limiting ‘core monitoring routine’ and grow into an expanded business resource to the benefit of aspiring and participating study sites and sponsoring organisations.
This article will initially present a broad outline of this role enhancement concept, as well as a business/operational rationale for its development and successful implementation within industry. A follow-up article will examine in greater detail what are perceived to be potential benefits, as well as inherent challenges, of the successful leveraging of the expanded business role of field monitors in our pharmaceutical clinical research environment.
THE ROLE OF A FIELD MONITOR
The field monitor is responsible for influencing study site personnel through an effective collaborative working relationship to achieve peak performance in all inter-related spheres of clinical research business activity. It should be noted that while some of the concepts about to be explored may work to some degree within a project-based model, this definition is really meant to be applied to a regionally-based monitoring organisation.
Also, many of these concepts assume an already established monitoring group. Whilst part of this definition has been used in defining the roles of senior clinical research associates and some site managers, it is believed that the full breadth intended is rarely put into practice. I wish to dissect the intentions of the role and highlight that it is more than a mere title change or a few added responsibilities.
Business Partners
With this definition, the monitor must be able to develop and grow business partnerships. Hence, one must be able to assess site performance from an organisational business perspective, to diagnose problems with efficiency and effectiveness and to assist sites at resolving misalignments or identified gaps. The monitor would participate as a business partner in developing and implementing a solid business plan. Needless to say, individuals fulfilling this enhanced role must possess the necessary skills to develop and enhance a business partnership over time. |
