Subscribe by Email

Your email:

Browse by Tag

RxTrials Communiqué - A Blog About Clinical Research

Current Articles | RSS Feed RSS Feed

The Current State of Clinical Study Startup

RxTrials welcomes Erik Sam and Dan Manak with goBalto as guest bloggers who wrote the post below:

Clinical study startup (SSU) has consistently been referred to as the “bottleneck” in any clinical trial.  This entire process of identifying sites, exchanging CDAs, questionnaires, regulatory documents, and the endless back and forth that takes place between sponsors, CROs, and sites has been described as “one giant mess.”  Sponsors have a difficult time finding the right sites and initiating them in a timely manner.  more...

Comments

We were also using an Excel spread sheet for start up for many years to track our sites study sytart up process for numerous studies. This method became very inefficient. Recently our IT Department created a tracking system on SHAREPOINT that allows mulitple users to track documents realtime. We can also run montly reports on multiple metrics. We have a few glitches that we are working through. So far we are happy with this solution.
Posted @ Thursday, January 27, 2011 4:19 PM by Deena Bernstein
I have been a coordinator, monitor, trial manager and director of clinical until I eventually left to start my own business. We build CTMS and EDC systems designed to address the problems raised in this article. Our systems help map and streamline activities associated with trial start-up and day-to-day activities of managing trials. Feel free to contact me if you would like more information.
Posted @ Tuesday, April 19, 2011 8:08 PM by Nuala Ronan
Post Comment
Name
 *
Email
 *
Website (optional)
Comment
 *

Allowed tags: <a> link, <b> bold, <i> italics