Your Complex Outcome Measures and Assessment Solution
Drawings and Video? Complex Scoring? Lunexis™ eCOA.
Clinical Ink’s integrated Lunexis™ eSource platform is the most robust and extensible eCOA solution available for administering complex rating instruments. Audio and video (A/V) capabilities facilitate rater review to ensure inter- and intra-rater reliability. A/V can also be implemented for use with central raters.
In therapeutic areas such as CNS, unwieldy rating instruments may involve multiple tasks with convoluted scoring and require clinicians to deliver detailed judgments consistently. With the support of our experienced team, you will be able to streamline work flows and obtain clean, complete data for these challenging studies. Then, once a data set is complete — which is more likely with our system’s real-time prompts and edit checks — complex scoring can be generated automatically. You can monitor data as they come in and query as appropriate.
Flow Complex Data Into the E-Record Effortlessly With Direct Data Capture
If you use a paper-based system and transcribe everything into an EDC, you waste time and risk incurring errors with the transcription step. How do you share and track data that can’t be entered or uploaded to the EDC, such as videos and images of drawings? With Lunexis, you simply record these data points with the built-in camera on your tablet, and they are immediately captured and stored as part of that subject’s digital record, accessible to remote study teams.
Get Expert Assistance and Be Confident You Are Choosing the Right Data Collection Tools
In our experience, clients have varying degrees of familiarity with the assessments they expect to use in their studies. Our specialized team will ensure you choose the best path to collect the right data to support your primary endpoints. With Clinical Ink’s expertise, you’ll get the integrated eSource data capture solution that smooths data collection and evaluation for your trial. You’ll get clean, complete data delivered right away.
Rater Support: Use Video to Check for Rater Reliability and Drift
You need to ensure inter-rater reliability and monitor for rater drift. Our audio and video direct data capture capabilities can easily be leveraged to support remote capture of the clinical interview and assessment process. You can decide whether rater retraining is in order.
Our system enables queries on specific rater responses to ensure consistent scoring or to confirm that overall interview performance is consistent with the protocol.
Be Proactive Regarding Linguistic and Cultural Issues
Global studies utilizing complex rating instruments require special consideration. Is that assessment you planned to use only validated in English? Will that be a problem? Beyond language, are there cultural issues involved in the translation? At Clinical Ink, our experts work with translation partners and licensing and copyright experts to ensure that we implement an eCOA solution that works everywhere you need it to.