Clinical Endpoints
eCOA That Goes
Beyond Collection
The Koneksa Platform captures electronic clinical outcome assessments (eCOA), from performance tasks and clinician assessments to ePROs, on the same system as your wearable and sensor data, then continuously monitors, reviews, and analyzes them as they arrive.
One system of record, from the first assessment to a submission-ready dataset, so you see earlier signals with fewer patients.
13+
Years pioneering remote evidence
50+
Clinical programs supported
55+
Countries
85+
Abstracts, patents + publications
Every eCOA Type,
One Platform
Many eCOA platforms were built around the questionnaire, with wearables added later. The Koneksa Platform was built from the start to capture every type of clinical outcome assessment in one patient app, on the same timeline as your wearable and sensor data.
- Performance outcomes (PerfO): measure what patients can do, not just what they report.
- Clinician-reported outcomes (ClinRO): consistent ratings, visit after visit.
- Patient-reported outcomes (ePRO): the context behind the data.
- Observer-reported outcomes (ObsRO): caregiver and observer reporting in the same app.
100+
Instructed-task measures
40+
Coached assessment measures
35+
eDiary + ePRO measures
Parkinson's Disease Case Study
Koneksa supported VOICE-PD (NCT05421832), a speech-based digital biomarker study in Parkinson’s disease with Northwestern University and Aural Analytics, funded by The Michael J. Fox Foundation.
eCOA That Finds Meaning
as Data Arrives
Most eCOA platforms stop at collection and hand you a dataset at the end.
At Koneksa, data stewardship comes first.
The Koneksa Platform works on your data while the study runs: every assessment is continuously monitored, checked, processed, and analyzed as it comes in, on the same timeline as wearable, sensor, and voice data from any qualified device. That lets you:
-
- Catch gaps early: edit checks, completeness, and compliance flags as each assessment arrives, so issues get fixed within the visit window, not at database lock
-
- Compare reported with measured: check reported sleep against measured sleep, or a clinician’s motor score against continuous tremor data
-
- See measures in real time: validated pipelines turn raw task and sensor data into digital measures as they arrive
-
- Act on early signals: our data science team reviews incoming data for outliers, rater drift, and unexpected trends, with biostatistics and data management experts in the loop
15+
Device + solution integrations
60+
Single + multi-sensor device measures
One App for Patients, One View for Your Team
Patients shouldn’t juggle a diary app, a wearable app, and a task app.
In the Koneksa app, they complete performance tasks, ePROs, and guided assessments, and sync wearable data from home, with in-app videos and guides that keep participation simple. Fewer logins, fewer handoffs, less burden. When someone chooses to join a study, we owe them a trial that learns as much as possible from their participation without asking them to do more.
Study teams get the other half:
One web application to activate devices and monitor compliance, adherence, and incoming measures in real time.
eCOA Data That's Ready for What Comes Next
eCOA data shouldn't need a second cleanup before analysis. Assessments flow into a single, GxP-compliant system of record, are formatted to SDTM + ADaM, and move on to Lodestar for FDA- and EMA-ready submission.
Capture
Audit trails and edit checks at entry
Manage
Compliance monitoring and data management in one place
Analyze
SDTM + ADaM-formatted outputs for biostatistics and statistical programming
Submit
From EDC to eCTD with Lodestar
Built for Requirements No One Has Solved Yet
Novel endpoints come with novel requirements.
Our subject-matter experts solve the new. When an off-the-shelf eCOA can’t do what your protocol needs, our clinical scientists and engineers design it, validate it, and deploy it on the same platform.
Video capture is one example.
Koneksa can video-record clinician-led and patient assessments, giving sponsors and regulators an auditable record that each one was standardized, neutral, and consistent, without unblinding the study.
Proven Performance
700+ People with Parkinson’s Assessed
700+ people with Parkinson’s assessed with Koneksa’s smartphone motor + speech tasks across six prospective studies since 2021, from academic research to Phase II sponsor trials.
Eight Phase III Programs Awarded
In the past six months, Koneksa has been awarded eight Phase III programs spanning database build, data management, and statistics, alongside eCOA, wearables, and video capture for endpoint confirmation.
Your Partner, Not Another Vendor
Koneksa works behind CRO teams to make digital measures easier to bid, start up, and deliver.
Partner with Us
eCOA + ePRO FAQs
What is eCOA in clinical trials?
Electronic clinical outcome assessment (eCOA) is the electronic capture of measures that show how patients feel, function, and survive. It covers patient-reported (ePRO), clinician-reported (ClinRO), observer-reported (ObsRO), and performance outcomes (PerfO), collected on phones, tablets, or the web instead of paper.
What is the difference between eCOA and ePRO?
ePRO is one type of eCOA: outcomes the patient reports directly, such as symptom or medication diaries. eCOA is the broader category, which also includes clinician-reported, observer-reported and performance outcomes.
What is a performance outcome (PerfO) assessment?
A PerfO is a standardized task the patient performs, such as a finger tap or timed walk, scored on how they perform rather than how they rate themselves. On the Koneksa Platform, PerfOs run on the patient’s phone with sensor capture, so they can be repeated at home between visits.
Can eCOA data be combined with wearable data?
Yes. The Koneksa Platform captures COAs and wearable and sensor data in the same patient app, on the same timeline, in one system of record. That lets you compare reported and measured outcomes and use COAs as anchor measures when validating new digital endpoints.
Does Koneksa analyze eCOA data during the study?
Yes. The Koneksa Platform continuously monitors, checks, and analyzes every assessment as it arrives, alongside wearable and sensor data. Our data science, biostatistics, and data management teams review incoming data for gaps, outliers, rater drift, and early signals, so issues are fixed during the study rather than at database lock.
Do digital measures replace clinical scales?
No. Koneksa uses digital measures to support and de-risk regulator-accepted scales, not replace them. Continuous data can help explain unexpected scale results, reduce noise through better stratification or eligibility, and serve as supportive, secondary, or exploratory endpoints.
Can clinician-rated assessments be captured on video?
Yes. Koneksa’s video capture records clinician-led assessments, with annotation that adds clinical context without altering the score. Sponsors get an auditable record, including redacted audio and video, that supports protocol adherence, central review, and endpoint integrity without unblinding the study.
How does eCOA data get from capture to submission?
On the Koneksa Platform, eCOA data flows into a GxP-compliant system of record, is formatted to SDTM + ADaM, and moves to Koneksa’s biostatistics and data management teams. Lodestar then supports submission assembly from EDC to eCTD.
Does Koneksa work with CROs?
Yes. Koneksa works behind CRO teams as a delivery partner for eCOA, wearables, video endpoint capture, and database build, with build-only and hybrid models. We help CROs de-risk innovation, reduce operational burden, and bid digital measures with confidence.
