eSource Platform

Comprehensive Platform

Clinical Ink’s eSource platform is uniquely designed to be used in the critical moments that matter: by sites during the patient visit itself, by patients as part of their daily life and by monitors or data managers in real time. This emphasis on these critical moments allows our platform solutions to comprehensively impact protocol execution and the key trial results that matter most.

Comprised of three modules, Capture, Insight and Engage, Clinical Ink’s eSource platform can be deployed as a fully integrated EDC-eCOA-ePRO solution or as a single point solution based on the specific needs of your study.


Next-Generation EDC and eCOA

Capture is a next-generation EDC system that streamlines clinical development by replacing inefficient paper source and eCRFs with intuitively designed eSource documents. Unlike traditional EDC, Capture is designed to mimic typical site workflows while permitting data to be collected and validated electronically at the point of care. This eliminates source document verification (SDV), significantly reduces data queries and allows for real-time online monitoring.

With capabilities beyond the basic data collection functionality of the market-leading EDC systems, Clinical Ink’s next-generation EDC supports the full range of validated eCOA questionnaire types: ClinROs, ObsROs, PerfOs and Structured Diagnostic Interviews. Capture has been used to convert even the most complex paper-based eCOA instruments into electronic formats and simplify the use of these questionnaires.

 

  • Improves Protocol Execution
  • Reduces Site Burden and Eliminates SDV
  • Enforces Critical Protocol Workflow
  • IWRS / Drug Supply / Informed Consent Integration
  • Familiar Feel and Site-Centric Design
  • Combined Source and CRF
  • Cross-Form Data Validations
  • Patient Questionnaire Workflow Support
  • Collect Data, Documents, Audio and Images
  • Full Offline Functionality

 

 


Data and Document Review and Query, Reporting and Analytics

Insight offers real-time access to both source data and source documents to permit true centralized monitoring and eliminate SDV. Minutes after the patient visit, the data and documents can be monitored remotely, eliminating weeks-long delays between monitoring visits. Critically, the site burden is reduced by more focused monitor-site communication and simplifying the query process; in fact, some queries are even eliminated. Insight also exposes critical documentation that existing systems can’t. Review handwritten notes, automatically flag key data and documents for review and compare multiple form versions to see what has changed.

 

 

  • Real-time data and document review
  • Complete audit trail of all source form versions including role-based access restrictions
  • Simple document-based data query process to reduce data query cycle time
  • Dynamically trigger required form reviews based on conditional data values
  • Centralized monitoring of source documents for protocol compliance
  • Increase the frequency and focus of site communications
  • Review audio recordings, supporting documents, handwritten notes and images

 


ePRO and Patient Engagement

Engage is designed to improve the patient experience. Engage helps patients easily understand the When, What and Why of participating in clinical research.

This ease of use extends to the study build process with true point-and-click configuration designed for rapid prototyping. Reset your expectations of what ePRO means with Engage.

1Tufts, CSDD Impact Report. (2018). (Vol. 20, Report No. 4).

 

 

  • Collect ePRO data anywhere, anytime
  • Intuitive “What Do I Do?” interface
  • Rapid point-and-click prototyping
  • Library of questionnaires and other content to shorten study start-up timelines
  • Flexible deployment model fully provisioned or BYOD
  • Full local language support
  • Customizable alerts
  • In-app training
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