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Preventing Quality Issues: A Risk-Based Approach to Clinical Trial Monitoring
The traditional Gold Standard method of monitoring clinical trials involved on-site monitoring with 100% Source Data Verification (SDV) where Clinical Research Associates checked every data point of information reported. This may have been doable in the past when...
Are you happy with the results?
Over the years we have seen the world of pharmacy evolve from that of ‘Dispense and Supply’ to include an ever expanding range of clinical services, (medicines management, local enhanced services such as vascular checks, managing minor ailments and sexual healthcare...
The MHRA Inspection Build-Up
Never has the corny old adage “Fail to prepare, prepare to fail” – so glibly used at times – been more wholly appropriate than for the build-up to an MHRA Inspection. It’s a demanding process requiring detailed attention, comprehensive descriptions, staff inclusion...