Overview Quality Risk Management (QRM) is an integral part of the corporate Quality Management System. Effective QRM is fundamental to ensuring the protection of human

Overview Clinical Site Audits are performed by Sponsors as part of quality assurance implementation in the Clinical Study (Trial). The audit is independent of and

Overview Project Management activities are essentially required to start-up, execute, and complete a particular Clinical Trial (Study) project in compliance with study protocol, other Sponsor’s

Overview The vital part of each Clinical Trial conduct is management of Essential Documents. According to established Good Clinical Practice (GCP) guidelines “Essential Documents are

A Clinical Trial can have multiple Third Party Vendors requiring effective oversight which can be challenging for Sponsors. The proper documentation proving continuous oversight must

Overview As per Good Clinical Practice (GCP) guideline “the purposes of trial monitoring are to verify that: a) The rights and well-being of human subjects

Overview Feasibility and Site identification are fundamental critical aspects of planning and executing successful Clinical Trials. Feasibility and Site identification involves identifying potential Sites that

Overview Regulatory Affairs are staff whose main responsibilities are to prepare and perform submissions of clinical trial materials to Regulatory Authorities (RAs), Institutional Review Boards

Overview According to the Good Clinical Practice “The Investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of

Overview The majority of Clinical Trials are international and run in multiple countries, so in order to make their conduct successful many trial-related documentation needs