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International Clinical Trials
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| 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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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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Dr James Thomson to lead new Stem Cell and Regenerative Medicine Center within the new Morgridge Center for Discovery on UW-Madison campus
By
Tom Still
MADISON – There’s no one alive today who was around to witness the birth of
Wisconsin’s
dairy and cranberry industries in the late 1800s, or its rise as a
manufacturing power in roughly the same era. But a new page in Wisconsin’s history of
commerce is being written in our time – the emergence of stem-cell medicine.
Recent events have solidified Wisconsin’s edge as a
global leader in stem-cell research and the breakthroughs in human health it
will produce (continued):
More info >> |
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