Chiltern, a contract research organisation (CRO), has introduced Chiltern SAFE, a records management for clinical trials.
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Chiltern said that SAFE is a complete electronic Trial Master File (TMF) solution which facilitates remote management of documents, which saves administrative time and increases accuracy and security of records handling.
Chiltern records management director Sarah Hitching said that Chiltern SAFE was revolutionising records management for clinical trials.
The company claims that the Chiltern SAFE is able to handle a range of metadata and is able to record whether a document on file is the original or a copy.
"It has many great features, all with integrated quality controls such as a duplicate document warning system and tracking of expected and missing documents as well as electronic submission of documents that do not require original signatures," Hitching said.
Chiltern Global Clinical Monitoring executive vice president Stuart Young said that they offer Chiltern SAFE as a standalone service or as part of their full clinical trial service package and for future or historic studies.
Chiltern CEO Glenn Kerkhof said that Chiltern SAFE is a comprehensive global TMF management solution designed to centrally control, track and maintain all study-related documentation.
"Its capabilities allow quick document search and retrieval as well as instant access to real time reports, user activities and study information," Kerkhof said.
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