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Implementing Electronic Data Capture (EDC) systems in Clinical Trials

Clinical Data Management Team

Clinical Trial Management Systems (CTMS) are an important part of every clinical trial. Selecting the right CTMS helps address inefficiencies on the operational side of research, such as clinical trial planning, preparation, performance and reporting. As more and more pharma and biopharma sponsors start to recognize the potential opportunities that exist with EDC-CTMS integration, there is a growing need to address the complex process of electronic data capture (EDC) implementation.

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Topics: Clinical Data Management, Electronic Data Capture, Paper-Based Studies, eCRF, Case Report Form (CRF), CDISC, CDISC CDASH, Outsourcing Solutions

CDISC European Interchange, Stockholm, April 2012 – a Summary

Clinical Programming Team

A member of the Clinical Programming Team writes about their experience at the CDISC European interchange in Stockholm held on 18th-19th April 2012.

As part of the CDISC European Interchange meeting, I contributed a presentation on how Quanticate have used the CDASH standards to facilitate data capture and transformation to the SDTM standard.

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Topics: CDISC SDTM, SDTM Domains, CDISC, Standardization, ADaM Datasets, CDISC CDASH, CDASH, CDISC Interchange, CDISC ODM

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