Summary of features
e-SOCDAT™ is an innovative, all inclusive, single platform eClinical solution, providing the following features:
e-DESIGN
The
e-DESIGN interface enables the design and creation of
e-CRFs, the development and implementation
of online queries, and the development of instructions and guidance for data collection and
e-CRF completion.
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e-DC
The
e-DC feature allows site personnel to capture and access data for patients from their site.
The quality and completeness of the data are enhanced during data capture by automated, validated online
queries and instructions and guidance available online. The electronic data management functionality facilitates a true multidisciplinary approach to data management.
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e-STA
The
e-STA feature allows online study treatment randomisation in addition to a secure study
treatment code access.
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e-SAFETYM
The
e-SAFETY functionality enables the collection of adverse and serious adverse event data in
addition to the execution and management of pharmacovigilance related activities.
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e-ENDPTM
The
e-ENDPT
M feature enables the
collection of data required for endpoint classification in addition to facilitating endpoint adjudication by
the Critical Event Committee (CEC).
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e-TMF
The
e-TMF functionality
enables the electronic management of the Trial Master File (TMF). The TMF documents, once uploaded, are visible on a continuous basis for authorised users.
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e-STUDYM
The
e-STUDY functionality enables the management and sharing of clinical and operational metadata
easily and efficiently between the multidisciplinary teams involved in a research project from a variety of locations (i.e. sites, sponsor and coordinating centre).
This functionality also enables CRAs to easily manage on-site visits and contacts.
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