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Clinical Data Management Team

Clinical Data Management Team

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

Medical Coding in Clinical Data Management

Clinical Data Management Team

In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.

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Topics: Adverse Events (AEs), Clinical Data Management, Medical Coding Dictionary, WHODD, Medical Coding, MedDRA

The Promise of Electronic Data Capture - How Soon is Now?

Clinical Data Management Team

Do you remember where you were when you heard the slogan, ‘Cleaner data faster’? That was the promise of Electronic Data Capture (EDC). A brave new world. Those of us at the forefront of EDC, or Remote Data Entry as it really was, may well remember the change resistance demonstrated by various stakeholders combined with the enthusiasm of early adopters.

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Topics: CDISC, Phase I Studies, Case Report Form (CRF), Remote Monitoring, Remote Data Capture, Tablets, Electronic Data Capture, ePRO, e-Clinical, eCRF, Electronic Medical Record (EMR), Source Data Verification (SDV)

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