Chiltern Launches 'Chiltern SAFE,' a Comprehensive Global Trial Master File Management Solution

By Chiltern, PRNE
Sunday, November 14, 2010

LONDON, November 15, 2010 - 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,
stated Sarah Hitching, Chiltern Director, Records Management. "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

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. 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, commented, "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."

Company profile

About Chiltern:

Established in 1982, Chiltern is a leading global Contract Research
Organization with extensive experience conducting and staffing international
Phase I to Phase IV clinical trials across a broad range of therapeutic areas
for a wide variety of clients. Chiltern has conducted trials in more than 40
countries, has 24 offices and legal entities within 20 countries, resources
in 37 countries and employs nearly 1,400 people globally. Chiltern provides
Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and
Regulatory Affairs and Resourcing Solutions services. Further information:

    For More Information Contact:

    Natalie Chong, Marketing Director   Susan Ojanen, Marketing Associate
    Chiltern International Ltd.         Chiltern International Inc.
    171 Bath Road                       1241 Volunteer Parkway
    Slough                              Suite 950
    Berkshire SL1 4AA                   Bristol, TN 37620
    UNITED KINGDOM                      USA
    Tel:  +44-(0)-1753-512-000          Tel:  +1-(423)-968-9533
    Fax: +44-(0)-1753-511-116           Fax: +1-(423)-968-3567
    Email:   Email:

Natalie Chong, Marketing Director, +44-(0)-1753-512-000, fax, +44-(0)-1753-511-116, natalie.chong at, or Susan Ojanen, Marketing Associate, +1-423-968 9533, Fax, +1-423-968 3567, susan.ojanen at, both of Chiltern International Inc.

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