spacer
home > ict > spring 2008 > sound starts
PUBLICATIONS
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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

spacer
Frank Dunn
spacer
spacer
spacer
Jeffery J Bowden
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Nemera acquires Insight Product Development to strengthen its capabilities

“Every day at Nemera, we work to improve the lives of millions of patients worldwide by designing, developing and manufacturing innovative drug delivery devices. Our vision as a team is to become the most patient-centric drug delivery device company in the industry. We partner closely with our customers to deliver innovative and high quality devices, to ensure that patients will receive the best product and service possible” Marc Hämel, CEO
More info >>

White Papers

Smaller, Smarter, Electronic, Connected: The Next Generation of Drug-Delivery Devices

Phillips-Medisize

An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders. Patients wishing to claim more autonomy over their drug regimens, caregivers and medical professionals wanting to more closely monitor drug compliance, health insurance organizations looking to keep costs down, and developers of pharmaceutical products interested in conducting better managed clinical trials can all benefit from these novel, next-generation technologies.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement