PRNewswire–Chiltern International Limited (Chiltern), a global contract research organization (CRO), announced the launch of Chiltern SAFE.
“Chiltern SAFE is revolutionizing records management for clinical trials,” said Sarah Hitching, Chiltern Director, Records Management.
Se said: “This complete electronic Trial Master File (TMF) solution facilitates remote management of documents, which saves administrative time and increases accuracy and security of records handling.
“It has many great features, all with integrated quality controls such as a unique duplicate document warning system and tracking of expected and missing documents as well as electronic submission of documents that do not require original signatures.
“Features like these ensure the process delivers the highest compliance and quality possible, with the greatest level of efficiencies.
“In addition, Chiltern SAFE is able to handle a wide range of metadata and is able to record whether a document on file is the original or a copy.
“We are also proud to announce that this system is fully validated and compliant with 21 CFR part 11 and other regulations.”
Stuart Young, Chiltern Executive Vice President, Global Clinical Monitoring, added: “We offer Chiltern SAFE as a standalone service or as part of our full clinical trial service package and for future or historic studies.”
He said: “Another distinct advantage of Chiltern SAFE is our dedicated records management (RM) team on site at each of our three data repositories globally: Germany, UK and USA.
“This team of TMF experts work in partnership with our clients to guide users through Chiltern SAFE, thus ensuring the system is not only “SAFE”, but also effective and user-friendly.”
Glenn Kerkhof, Chiltern CEO, said: “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.”