DICE – Debarments, Inspections, Compliance and Enforcements for Clinical Trials.

Written by Global_PM_Systems Posted on Wednesday, October 23, 2013 No Comments

Today, Sponsors have a growing concern about the selection of the Clinical Investigator during recruitment. As many pharma and healthcare companies outsource the entire clinical trial to CRO’s , the expectation is that the CRO’s have been diligent in their selection of an investigator in that the investigator is experienced in the field and has a clean record of trial performance. As there are many areas of concern during Study Site Startup (‘SSSU’), compliance remains a key area for the

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CA PPM for Clinical Trial Management – The Key is in the structure

Written by Global_PM_Systems Posted on Friday, September 6, 2013 No Comments

CA PPM CTM – The Key is in the structure

Why do so many Pharma and CRO companies struggle with the management of Clinical Trials? The solution does not begin at the project level. The solution begins at a much higher level. In order to manage various tasks and submissions, the projects must adhere to a structure that makes sense to the organization; however, the structure must be scalable enough as to not drive the project managers crazy in trying to figure

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