Site Development Series: Know Your Value Before You Grow It!

There is no secret to developing and expanding an investigative site, the requirements involve a conscientious identification of subjective and objective criteria that highlight the opportunities for growth and the supporting controls needed to reinforce developmental phases. Focus must be on all staff participating in study conduct including clinical trial coordinators, principal and co-investigators administrative support staff and external contractors. With this in mind, whilst providing an important insight into the vital considerations and complexities of conducting clinical research at a site, for sponsors and CRO’s these business evolution concepts are aimed at fostering appreciation of the components required to drive successful site performance and operational excellence.

Clinical trial sites in Australia provide valuable and meaningful contribution to their local and surrounding communities by way of providing access to novel and compelling therapies for a variety of disease states. The value to customers, such as sponsors and CRO’s is addressing an area-based necessity for clinical trial data in a professional and concise way that is cost-effective. This is through access to an underrated and relevant target population, aggressive recruitment and provision of data excellence.

Effective site operation and development creates a capacity to achieve these essentials and more including dynamic protocol requirements by providing dedicated specialist investigators, multi-disciplinary supporting teams and facilitation of external provider cooperation and partnerships (e.g. hospitals, Medical Imaging, Pathology). Implementation of a culture of excellence and delivery provides unique profile and reputation growth professionally, not only for investigators but for all site staff as well. Combined with a provision of expertise in a certain therapeutic area, this serves to offer specific data collection and outcomes opportunities that are both paramount and vital for sponsors and CRO’s to achieve regulatory approval and subsequent commercial success.

Potential for growth within your research business is often clear although requires measured management of progressive operational excellence initiatives of internal infrastructure including building planning, personal requirements and business expansion. Translating initial and/or past achievement into continuing success requires an ongoing understanding of the clinical trials marketplace. This includes assessment of competition. We must ask:

• “Who does what we do in our area?”
• “Who participates in the same niche medical specialty trials as we do?”
• Then ask the questions:
• “What can we do differently?”
• “What additional value can we offer?”
• “How can we do what they do better?”

Individual site advantage in the clinical trials marketplace is a combination of medical specialty, trial diversity expertise and both real and potential capability that appeals to target populations. There are few industry benchmarks or guidelines for site best practice therefore it is the sites responsibility to develop benchmarks of their own and build a business that fosters meaningful relationships with consumers and attracts ongoing trial opportunities as a function of performance, competitiveness and reputation.