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 Evolutions
in technology, quality obligations and time restrictions naturally
converge towards a new organisation in study management. If electronic CRFs are
slowly but progressively being used, their advantages are obvious. Of course,
the success of this new organisation relies on the respect of prerequisites
taking into account human, technical and cultural factors. Implementation of
electronic CRFs is part of a medium to long term strategic project for
businesses.
The
INES solution is composed of different software modules dedicated to
clinical study management and trials on Internet and Intranet.
INES
is an innovative answer, entirely developed using Internet technologies
(1). INES can manage data collection (2), data management (3) monitoring (4),
and reporting (5). The study set-up module (6) enables both conception of the
CRF and edition of data management checking.
Already
in use in several clinical studies and trials via Intranet and Internet, the
simplicity of use makes it easy for Investigators to enter data via Internet
without having to take any training on INES. In accordance with the FDA
regulations 21 CFR PART 11 concerning electronic CRFs, INES guarantees secured
hosting (7), data transfer, and system checks for accessing functions and
software data.
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