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eFFICE
eCRF
SMART
eArchive
eFFICE
Electronic office/efficient office: eFFICE – this is a web based management system for clinical trials based on a collaboration with Datapharm Australia Pty Ltd and Docbanq Pty Ltd ( www.docbanq.com ). It allows our regional monitors to share documents and files in a clinical trial specific, secure, online management system that provides a data trail and allow all trial electronic documents to be archived simply to an electronic TMF at the completion of the clinical study.
eCRF
Datapharm is currently providing access to remote data capture (RDC) through its newly launched eCRF (electonic CRF). This allows the site to complete an electronic case record form (eCRF) with embedded electronic checks and to enter direct to a secure server via web based access.
SMART
We have also developed SMART (Smooth Monitoring A Resource Tool), a software application that allows prediction of monitoring resource requirements over a two year period. It is continually updated for new studies in an iterative manner. It allows for adjustment of estimated resources based on actual monitor and site productivity.
eArchive
Datapharm is able to archive to CD/DVD using well indexed and searchable pdf files. This facility will be provided as a service to clients to archive which can be stored in eFFICE:
• large trial master files (eTMF)
• final sets of CRFs
• regulatory files
• any other relevant clinical documentation
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