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— Clinical Trials —

Connected Devices & Measures

Koneksa supports a broad spectrum of digital measures —

configured to meet study needs across therapeutic areas, trial phases, and data collection strategies.

Talk to an Expert

Koneksa App with Wearable Health Monitor Devices

Our Digital Measurement Catalog

Coached Assessments

Coached Assessments with Koneksa iPhone app and integrated devices

Used when consistent measurement is critical—such as for vital signs or tasks that follow a standard protocol.

2
Concepts

40+
Measures

eDiaries
and ePROs

eDiaries and ePROs

Ideal for high-frequency at-home capture. Configurable for scheduling and context-driven reporting.

21
Concepts

35+
Measures

Instructed
Tasks

Koneksa App Instructed Tasks

Designed to support a wide range of therapeutic areas and clinical applications through guided interactions.

6
Concepts

100+
Measures

Single / Multi- sensor Devices

Single and Multi Sensor Devices

Integrated device options tailored by study needs—balancing accuracy, wear time, and participant experience.

4
Concepts

60+
Measures

Learn more about our therapeutic areas

Digital Assessments

Below is a sampling of digital assessments with prompts and instructions from the Koneksa mobile app

Digital Assessments for Human Body

Sleep

Vital Signs

Pulse Oximetry

Gait + Balance

Cognitive

Speech

Tremor

Finger Tap

Physical Activity

Spirometry

Pronation/Supination Assessment

02:29

Postural Tremor Assessment

02:22

Finger Tap Assessment

00:50

Spirometry Assessment

06:39

Timed Walk Assessment

03:39

Learn more with our digital assessment demos below

For additional information, download our our product guides

Timed Walk
Assessment

Tremor Assessment

Pronation/ Supination Assessment

Finger Tap Assessment

Spirometry Assessment

Device Integration

Integrating digital health devices into clinical studies requires more than just hardware selection.

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

Let's Work Together

Whether you’re designing your first digital study or scaling a global program, Koneksa brings the science, platform, and people to deliver.

Schedule a Demo

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