DDC

Direct Data Capture (DDC) from Clinical ink is a best-in-class eSource technology designed to eliminate paper source documents and manual transcriptions in clinical trials. By recording patient data electronically at the precise moment of inception — directly at the point of care — DDC produces faster, higher-quality clinical trial data that is accurate, accessible, and fully traceable. The solution is purpose-built for sponsors, clinical sites, monitors, and patients who need a more efficient, compliant, and reliable approach to clinical data collection.

Unlike traditional Electronic Data Capture (EDC) workflows, which require data to be manually transcribed from paper research charts or electronic medical records into an EDC tool, Clinical ink DDC captures source data in real time. This eliminates the transcription errors, delays, and resource-intensive Source Data Verification (SDV) processes that commonly disrupt trial timelines. DDC also integrates seamlessly with EDC platforms, combining the benefits of point-of-care capture with existing trial infrastructure.

Core Technology Capabilities

• Workflows that simulate the clinician's natural assessment process for intuitive use
• Data entry screens mirroring familiar documents to reduce the learning curve
• Capture of ad hoc notes, audio recordings, images, and video embedded directly with clinical data
• Automated electronic audit trail generation to support regulatory compliance and oversight
• Built-in algorithms that prevent omission of required fields and flag incongruent, illogical, or inconsistent data entries
• Offline data capture functionality to ensure continuity when internet connectivity is unavailable
• Guided prompts to support protocol execution and completion of specific clinical assessments
• Configurable settings to comply with local data protection regulations across different geographies

Types of Data Collected

• Patient-reported outcomes
• Clinical assessments
• Laboratory results
• Imaging data
• eSource data from a broad range of clinical inputs

Benefits Across All Trial Stakeholders

• Patients: An intuitive, unobtrusive interface reduces participant burden and fosters easier engagement in clinical trials.
• Sponsors: Improved protocol execution reduces deviations and queries; automated site analytics and validated audit trails support faster database lock.
• Sites: Sites save approximately 30 percent of the time previously spent developing paper source documents and transcribing data into EDC systems, with data entered once and validated in real time.
• Monitors: Remote source data review (SDR) is enabled, minimising the need for on-site SDV, while comprehensive audit trails and system logs are readily accessible.

Key Benefits of DDC in Clinical Research

• Real-time access to accurate data, facilitating timely and informed decision-making
• Reduction in data errors through automated validation checks performed at the point of entry
• Enhanced patient engagement through user-friendly interfaces
• Compliance with regulatory standards for data protection and documentation
• Significant cost and time savings by eliminating manual paper-based processes and reducing data cleaning requirements

Platform and Ecosystem Integration

• DDC is a core component of Clinical ink's broader eSource ecosystem
• Enables ingestion of all incoming electronic data into a unified data platform
• Supports analytics within individual studies and across multiple studies
• Integrates with EDC platforms to deliver seamless, end-to-end data management

As a pioneer in DDC technology, Clinical ink delivers a solution that is configurable for local regulatory requirements and designed to support compliance throughout the trial lifecycle. By capturing source data at the moment of inception and unifying it within a single platform, Clinical ink DDC helps research teams save time, produce cleaner data, and build greater confidence in study outcomes.