Direct Data Capture
The Lumenis™ 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 Lumenis to meet the demands of your specific protocol with the functionality and services that are critical to your study across multiple therapeutic areas.
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 platform
Data/Documents available real-time No data entry error; site workload reduced
Explore Lumenis, a clear and connected eSource Ecosystem, that delivers purpose-built solutions for your protocol at the critical moments that matter. We built Lumenis to be used as the original Source document and to eliminate the need for a separate case report form. Data entered into Lumenis 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.
Lumenis 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, Lumenis 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 Lumenis 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 Lumenis 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 Lumenis to support well-informed, optimal decisions.