"I got to thinking about all the variables that could take place in a trial this size......The logistics involved in conducting any drug trial in multiple countries would be astounding I would think. The knowledge you would have to have regarding import and shipping laws and regulations.....The astounding number of humans involved In this operation could calculate into all kinds of human errors or mishaps. Millions of variables that could calculate into thousands of events. Kudos to any company that can coordinate such a monumental endeavour and to recognize, consider and account for any or all of the above examples alone."
Par for the course for randomized controlled trials. Keep in mind that Resverlogix is not acting alone and is collaborating with contract research organizations such as PPD, ICON plc and Medidata Solutions (as indicated in the ClinicalTrials.gov listing) with experience in handling these variables/logistics. Furthermore, the BETonMACE Clincal Steering Committee and other BETonMACE clinical investigators have much experience in running international clinical trials.
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