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MasterControl eTMF Manager for Medical Device™

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Data Sheet 1 Data Sheet D O C U M E N T S T A S K S M I L E S T O N E S M O N I T O R I N G A U D I T S S P O N S O R S C R O S S T U D Y S I T E S eTMF Manager MasterControl eTMF Manager for Medical Device™ Go Beyond Document Management The management of a trial master file (TMF) for a clinical study conducted for medical device products goes beyond simply managing the creation, review, and approval of content that is generated throughout a clinical study. Each clinical study must meet good clinical practice (GCP) regulatory standards for execution, such as ICH E6 and ICH E8 (which delineate the responsibilities and expectations of all participants in clinical studies), as well as the ISO 14155 standard for design, conduct, recording, and reporting of clinical investigations carried out in human subjects. The complexity of the protocol design and study execution brings about its own level of documentation, collaboration, information exchange, milestones, and activities that must be managed as evidence of GCP compliance and the scientific credibility of the clinical study. The ability to effectively manage the many interactions required by study participants and contributors – such as sponsors, contract research organizations (CROs), vendors, and sites – in a secure and organized manner helps to ensure the completeness, compliance, and "inspection readiness" of a clinical trial and its supporting TMF. The MasterControl eTMF Manager for Medical Device is an electronic trial master file (eTMF) management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager for Medical Device simplifies and streamlines the management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions.

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