SEPTEMBER Monthly Case Study Analysis:
Each month, we look at a different Clinical Trial Case Study ? this month it?s a look inside a Phase II Dose Ranging Dermatology trial that focused on Regulatory Environment issues.
The Scenario: A Phase II NDA trial with 4 expert sites, in 4 countries enrolled 80 patients, in less than four months with outstanding clinical results.
We asked ourselves: What if the deadline for this product became critical? In principal, they needed to finish the study for their development partner before they completed the preclinical safety dossier.
The client decided to conduct this study outside of the US so they would not need to submit the study to the IND.? Our international field, data accession, and consultant team selected and managed 1 site each in Ecuador, New Zealand, South Africa and Sweden. The team enrolled the required number of patients in just 16 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final CSR (clinical study report) ahead of schedule.
Our Answer: Criterium saved more than three months and met the client?s deadline for corporate evaluation of the product.
Preparing clinical trials from financial issues upfront is always the ideal, but extension dates and changing timelines are variables that have to be accounted for in planning.? When we look at trial bids, we look at all the factors that surround the potential issues facing a trial ? location & timing can be tools to keep trials running smooth, not just challenges to overcome.
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Claire WyntersWed, 19 Sep 2012 20:51:00 GMTf1397696-738c-4295-afcd-943feb885714:222699