Clinical Trials
All clinical trials begin with the development of a ‘study protocol’ which includes the following criteria: objective, design, selection criteria, study procedures and guidelines, etc. Clinical trial protocols act as a quality control tool for all aspects of clinical trials. The importance of this document is furthered in the case of multicenter trials.
A meeting held between the investigating team and the sponsors to review and discuss the study protocol before patient enrollment”. This meeting ensures that the principal investigator team is trained and competent to follow the study protocol and that the site passes a readiness assessment.
Site inspection is a process under which regulatory authorities/ appointed auditors conduct an official review of documents, facilities, records etc. Site inspections are conducted when clinical investigations are a part of a market authorization application.
This is a readiness checklist to verify that the site has appropriate personnel and operational capability to initiate the study. Readiness checklists are intended to be used before the start of study or during the initial visits to ensure site readiness and personnel preparedness.
Includes the procedures specific to the site that support trial participation safety, protocol compliance, data quality and integrity, efficient study completion, data storage and sharing, dissemination of results, etc.
Internal audits are conducted to provide independent assurance that organization’s and site risk management, Quality Management System (QMS) and internal control processes are operating effectively. Internal audit reports are used to monitor and influence improvement implementation processes.
Conlis Global Inc. has proven proficiency for establishment, execution and data compilation for clinical trials.
