Clinical Endpoints
Koneksa supports a broad spectrum of digital measures —
configured to meet study needs across therapeutic areas, trial phases, and data collection strategies.
Our Digital Measurement Catalog
Coached Assessments
Used when consistent measurement is critical—such as for vital signs or tasks that follow a standard protocol.
2Concepts
40+Measures
eDiaries
and ePROs
Ideal for high-frequency at-home capture. Configurable for scheduling and context-driven reporting.
21Concepts
35+Measures
Instructed
Tasks
Designed to support a wide range of therapeutic areas and clinical applications through guided interactions.
6Concepts
100+Measures
Single / Multi- sensor Devices
Integrated device options tailored by study needs—balancing accuracy, wear time, and participant experience.
4Concepts
60+Measures
Digital Assessments
Below is a sampling of digital assessments with prompts and instructions from the Koneksa mobile app
Learn more with our digital assessment demos below
Pronation/Supination Assessment
Postural Tremor Assessment
Finger Tap Assessment
Spirometry Assessment
Timed Walk Assessment
For additional information, download our product guides
Device Integration
At Koneksa, we offer an end-to-end framework to ensure devices are technically sound, usable by study participants, seamlessly connected, and operationally supported across global trials. Whether driven by a sponsor or internal roadmap, we make devices study-ready—faster and with less risk.
Device Evaluation
Ensuring the right fit—before you invest
We start with a rigorous assessment of device suitability, examining hardware reliability, software functionality, and available validation evidence. Our process ensures only viable, scalable solutions move forward.
Key Activities:
- Hardware and software assessment
- Evidence review for accuracy and reliability
- Device provisioning and readiness for study use
Regulatory Evaluation
De-risking your path to compliance
We evaluate regulatory status and risk for each device—ensuring alignment with FDA, CE, and other global standards. From certifications to vendor quality systems, we help you avoid hidden compliance issues.
Key Activities:
- 510(k) / CE mark verification as needed
- Vendor qualification (QMS compliance)
- Risk review via sources like MAUDE database
Verification & Validation
Generating evidence and trust
Each device integration includes a robust V&V process to demonstrate performance, reproducibility, and scientific validity. These studies often support publications, regulatory submissions, and internal validation.
Key Activities:
- Sensor verification
- Usability evaluation
- Analytical validation of outputs
- Generation of data for posters or peer-reviewed publications
