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International Clinical Trials

Sound Starts

Relationships built on trust, expertise and effective management tools pave the path for clinical trial success, contend Frank Dunn and Jeffery Bowden of Biomedical Systems

Clinical trials are endeavours of discovery. The questions that must be answered range from the mundane, such as logistics, to core questions about the safety and efficacy of a particular drug or medical device. Experience, sound relationships and effective tools carry those involved in the execution of clinical trials through the myriad of pitfalls and peaks to a successful conclusion of the study.

The seeds for the success of a trial, and ultimately clean study data, are sown in the beginning stages of the process. Study issues, for example shifting timelines, are inherent to trials and can only be resolved with clinical trial experience, process/product development and excellent communication between sponsors and the imaging core lab.

GOOD PROJECT MANAGEMENT IS ESSENTIAL TO STUDY SUCCESS

The transition from the initial contracting phase of a relationship between sponsor and lab to the start-up of the trial can sometimes be a volatile period, especially if the two have not worked together. The sponsor is anxious to be moving forward and may be a little apprehensive about placing their trust in someone new to the process. In this environment, it is important that the project managers (PM) quickly establish their credentials, develop a relationship, and understand the expectations of the sponsor and clinical team.


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Frank Dunn is Medical Writer, Imaging Services, at Biomedical Systems. Frank joined the company in 2006 following 22 years of Federal Government service. Prior to joining Biomedical Systems, Frank served as a Public Affairs Specialist with the US Coast Guard. His extensive experience in developing written documents that explain technical details on topics ranging from search and rescue cases to large pollution incident, natural disasters and terrorist attacks, have prepared him for the challenge of medical writing.

Jeffery J Bowden is President, Imaging Services, at Biomedical Systems. Jesse joined the company in 2004 as Vice President of Imaging Services. Prior to that, he was Assistant Director of Clinical and Regulatory Affairs with Tyco Healthcare, Mallinckrodt and Director of Applications Development for Intelligent Imaging. He also created and managed the in-house imaging core laboratory instrumental in supporting the Imaging Clinical Trials for Nycomed, Inc (which is now a part of GE Healthcare). Jesse has created and managed four imaging core laboratories from their inception and has participated in over 150 clinical trials. He has developed numerous proprietary applications designed for the collection, analysis and storage of clinical data acquired during clinical trials.

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Frank Dunn
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Jeffery J Bowden
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