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ClinSpark is the only CDISC ODM certified eSource platform for early phase clinical trials and site automation for all phases. We use AWS' class-leading hosting services in either North American or EU (and coming soon in future AsianAPAC) regions.
We supply ClinSpark to a number of CROs and Pharmaceutical Company Phase I units in the US and Europe and are engaging with our first sites in APAC.
ClinSpark is different to EDC systems, where the source data is captured on paper and then transcribed to an eCRF. EDC is usually deployed by the sponsor or CRO and used on demand, one study at a time. However, with eSource, it is the sites themselves that adopt ClinSpark as their platform for the conduct of all their clinical trials, and as a way to increase compliance, reduce errors and increase efficiency, as well as delivering SDTM-like exports in SAS® transport file format. In addition, the sites provide controlled and secure access to the source data in ClinSpark, to the trial sponsor and/or trial monitors. Importantly, the data is owned and retained by the investigational site.
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