Direct Data Capture
The Lunexis™ platform shifts the moment of data capture at its inception — from sites during the patient visit and from patients as a part of their daily lives. This seemingly simple but elusive goal eliminates weeks from the critical process of ensuring clinical data and documents are valid and available for analysis. The Clinical Ink direct data capture approach combines Source and CRF into a single document that ensures you collect the right data during the patient visit. We have built Lunexis to meet the demands of your specific protocol with the functionality and services that are critical to your study across multiple therapeutic areas.
DDC vs. EDC: What’s the Difference?
Direct data capture (DDC) and electronic data capture (EDC) may sound the same. But a closer look reveals fundamental differences with crucial implications for clinical research workflows, data quality, visibility, and timelines.
EDC adds to the cost and complexity of clinical research with byzantine workflows, a higher risk of incomplete or incorrect data, and audit tracking challenges for complex source types, and it takes two and one-half weeks to four months longer.
eSource DDC Approach
The Lunexis platform makes it easy to deploy an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. We deliver more than fast, clean data — we deliver confidence. Not only are your sites and patients assured of an easier experience, but our system facilitates success at NDA filing by promoting correct study conduct and documentation with remote monitoring and purpose-built, strategically designed workflows.
Direct Data Capture
Explore Lunexis, a clear and connected eSource Ecosystem, that delivers purpose-built solutions for your protocol at the critical moments that matter. We built Lunexis to be used as the original source document and to eliminate the need for a separate case report form. Data entered into Lunexis is validated immediately using sophisticated edit checks, cross-form logic, and dependencies and includes protocol workflow-based validations that are impossible with existing EDC systems.
Lunexis can capture not just data, but also documents, audio, video, and handwritten notes. This expanded and more comprehensive documentation satisfies the need to demonstrate that you have executed the protocol properly. Equally important, Lunexis simplifies the daily lives of site users by eliminating the most mundane activities, such as data transcription. It also reduces the need to interact with other common systems by directly integrating with both eICF and IWRS systems to simplify patient enrollment, randomization, and drug supply accountability.
Critically, the data from Lunexis 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 data sets, customized data exports, and/or study-specific reports. The Lunexis platform delivers these data in real time and is all supported by a team of data management professionals.
We deliver more than fast, clean data — we deliver confidence. Not only are your sites and patients assured of an easier experience, but you also can be certain that your patients are more compliant and engaged and that your protocol is executed correctly. Start your most complex studies with confidence — implement Lunexis to support well-informed, optimal decisions.