Clinical ink, a global life sciences technology company, has introduced a new integrated electronic data capture (EDC) system designed to revolutionize data management in clinical trials. The platform, named EDCXtra, represents a significant advancement in clinical research technology by combining multiple essential functions into a unified web-based solution.
Comprehensive Integration of Clinical Trial Technologies
The new platform integrates three critical components of modern clinical trials: direct data capture (DDC), electronic clinical outcome assessments (eCOAs), and electronic consent (eConsent). This integration addresses a long-standing challenge in clinical research - the need to streamline data collection while maintaining compliance with good clinical practice (GCP) standards.
Building on Clinical ink's 17-year legacy in DDC/eSource platform development, EDCXtra has already contributed to multiple FDA approvals. The system's architecture reflects this extensive experience, offering a sophisticated yet user-friendly interface for clinical trial data management.
Advanced Features and Flexible Implementation
EDCXtra's hybrid functionality sets it apart in the clinical research technology landscape. The platform enables:
- Real-time data entry for case report form (CRF) data
- Management of complex eCOAs through a unified interface
- Flexible data entry options for sites using paper CRF transcription
- Integration capabilities with interactive response technology (IRT) and laboratory systems
The platform's customization features allow research teams to tailor the system to specific trial requirements, ensuring optimal functionality across different study designs and therapeutic areas.
Impact on Clinical Trial Operations
Megan Petrylak, EVP of Clinical Operations at Clinical ink, emphasizes the platform's practical benefits: "We developed EDCXtra to improve the site experience by providing a single flexible EDC/DDC solution. The integration of EDCXtra in our end-to-end eClinical suite improves speed and quality of data capture while significantly reducing the administrative burden on sites."
The platform offers particular advantages for sponsors, including:
- Simplified study build process for EDC and complex eCOAs
- Cost-effective single-platform solution
- Customizable integration with third-party data systems
Therapeutic Expertise and Technical Capabilities
Clinical ink's platform development is supported by extensive therapeutic area expertise and advanced technical capabilities. The company's technology suite encompasses:
- Telehealth integration
- Digital biomarker monitoring
- Blood glucose monitoring for hypoglycemia detection
- Comprehensive eClinical solutions
This integrated approach to clinical trial technology reflects the industry's movement toward more efficient, patient-centric research methodologies while maintaining high standards of data quality and regulatory compliance.
