OverviewRegulatory Affairs are staff whose main responsibilities are to prepare and perform submissions of clinical trial materials to Regulatory Authorities (RAs), Institutional Review Boards (IRBs)/ Independent Ethics Committees (IECs) and…

OverviewAccording to the Good Clinical Practice “The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial…”, therefore proper training is…

OverviewThe majority of Clinical Trials are international and run in multiple countries, so in order to make their conduct successful many trial-related documentation needs to be translated, reviewed, and delivered…

Overview In order to run a successful clinical trial of pharmaceutical or medical device a large number of supporting trial materials (documentation) need to be created, reviewed, and implemented. Aim…