EDC

CURRENT EDC APPROACH

 

Capture subject data on paper forms; MOST IMPORTANT STEP!

3 days - 3 weeks before data is entered into an EDC system

Enter the data into the electronic system

2-10 weeks before the data is reviewed by a monitor

Review electronic record against paper source data for accuracy

Finally, clean valid data is available for analysis

EDC has not reduced the cost and complexity of clinical research

CLINICAL INK APPROACH

During the patient visit - enter subject data into eSource platorm

Data/Documents available real-time No data entry error; Site workload reduced

Monitor remotely

Capture Source and CRF during patient visit

Capture, Clinical Ink’s next-generation EDC platform, was built to be used as the original Source document and to eliminate the need for a separate case report form. Data entered into Capture is validated immediately using sophisticated edit checks, cross-form logic and dependencies and includes protocol workflow-based validations that are impossible to do with existing EDC systems.

Capture’s other unique benefits include the ability to capture not just data, but documents, audio, video and handwritten notes. This expanded and more comprehensive documentation satisfies the need to demonstrate that the protocol has been executed properly. Equally important, Capture simplifies the daily life of site users by eliminating the most mundane activities, such as data transcription,

as well as by reducing the need to interact with other common systems; Capture directly integrates with both eICF and IWRS systems to simplify patient enrollment, randomization and drug supply accountability.

Critically, the data from Capture meets the exact same standards of existing EDC systems. Depending on your downstream data needs, Clinical Ink can work with customers to ensure the successful creation of SDTM compliant datasets, customized data exports and/or study-specific reports, the Capture platform delivers these data in real time and is all supported by a team of Clinical Ink data management professionals.

Clinical Ink’s next-generation EDC solution is really just what you’d expect out of a modern EDC system.

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