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A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More
The FDA is strengthening its bioresearch monitoring program as part of a sweeping plan to overhaul its approach to inspections and regulatory monitoring. Read More
BioMerieux received a warning for its handling of complaints and nonconformances, including using roughly 546 complaint description codes that are not defined in company documents. Read More
CMS’s final rule updating and revising the end-stage renal disease prospective payment system for 2015 nudges up the ESRD PPS base rate to $239.43, from the base rate of $239.02 in 2014. Read More
For the first time, devicemakers will have to report financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
Cancer drug developer Southern Research Institute and the University of Alabama at Birmingham have formed a strategic partnership known as the Alliance for Innovative Medical Technology (AIMTech) to develop new medical devices, the two groups said Tuesday. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing regulatory restrictions increased by a double-digit percent from 2000 to 2012. Read More