eCOA + ePRO

Multimodal Measurement for eCOA and ePRO Programs

Regulator-accepted scales remain the foundation of clinical trial endpoints. Yet scales such as ALSFRS-R and UHDRS can be noisy in heterogeneous, non-linear diseases. As a result, a true treatment effect can be hard to see at readout.

Koneksa’s eCOA approach closes that gap. It pairs clinical outcome assessments with continuous digital measures and PROs, so every assessment arrives with the context needed to interpret it, with one biostatistics team analyzing the full picture.

Why Context Matters for the Endpoints You Rely On

We don’t replace accepted scales. We support and de-risk them. When a scale result is unexpected, continuous digital data and PROs help show why, instead of leaving the question open at readout. The same data can also work earlier. They inform run-in, eligibility, and stratification, and in one rare-disease study they identified about a quarter of patients unlikely to respond on the clinical scale. Meanwhile, digital measures can serve as supportive, secondary, or exploratory endpoints without rebuilding your program around a new primary endpoint. Because COAs, wearables, and sensor data are captured on one platform and one timeline, our data science team can review incoming data for outliers, rater drift, and unexpected trends while the study runs. Video capture adds another layer, showing that each assessment was standardized and neutral and helping reduce rater variability across sites. The result is precise measurement designed in upfront, which can mean shorter trials, smaller sample sizes, earlier go/no-go decisions, and fewer protocol amendments.

Inside the eCOA and ePRO Overview

• How we select and configure COAs for your indication, pair them with the right digital measures, and plan the path to regulatory acceptance
• Where continuous data and PROs add the most value, from stratification and supportive endpoints to video capture across therapeutic areas
• How validated measures carry from trial to trial, and how one biostatistics team takes the analysis through SDTM + ADaM to submission with Lodestar™

Download the overview, or schedule a scientific consultation to explore your eCOA and ePRO measurement strategy with Koneksa.