- Suitable for home monitoring
- Dashboard with measurement data from all participants
- Automated dashboard transmission
- Suitable for decentralized studies
- 24/7 continuous documentation
- Ready to integrate immediately
The new reference for clinical studies involving temperature
SteadyTemp is designed for clinical studies in which body temperature plays a role – whether as a primary endpoint or as an indirect indicator of participants’ health status.
The system delivers continuous, precise, and reliable temperature data, enabling complete mapping of temperature profiles throughout the entire study period. Unlike conventional measurement methods, data collection is unobtrusive and does not interfere with the study protocol or participants.
By combining a wearable sensor, digital data collection, and centralized analysis, SteadyTemp supports clinical studies in all phases – from planning through execution to analysis.
SteadyTemp is flexible, easily integrable, and suitable for a wide range of study designs, including traditional clinical trials, care settings, and decentralized and hybrid studies.
Study partners benefit from a scalable, practical solution with high data quality that opens new perspectives for research in which body temperature is used as a meaningful health parameter.
One system -
many research fields
SteadyTemp adapts to the study design.
Continuous temperature monitoring in inpatients.
Observation of temperature changes during treatments.
Comparison with established temperature measurement methods.
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ADVANTAGES OF STEADYTEMP IN CLINICAL STUDIES FOR CROs
We support Clinical Research Organizations in implementing clinical studies more efficiently, meaningfully, and economically.
- Automated data collection minimizes documentation effort.
- Fewer on-site visits and manual data collection reduce time and personnel costs.
- Early interim analyses accelerate decision-making processes.
More precise efficacy & safety evidence
- Ideal for studies with temperature-sensitive endpoints (e.g., antipyretics, vaccines, immunotherapies).
- The continuous curve allows precise determination of time-to-onset and time-to-effect.
- Improved differentiation between therapy-related fever and infections.
- SteadyTemp delivers continuous temperature data instead of isolated individual measurements.
- Complete recording enables precise representation of temperature profiles, fever phases, and treatment responses.
- Higher data integrity by eliminating measurement and documentation errors.
- Reduced monitoring costs through automated data collection.
- Shorter study durations thanks to immediately available, analyzable data.
- Improved subject compliance reduces drop-out rates and increases study ROI.
- Interface-compatible (FHIR/HL7, eCRF, CDISC) for direct integration into study platforms.
- Enables centralized monitoring via the SteadyTemp Dashboard or API integration.
- Scalable study packages (Light | Advanced | Pro) for every study size.
- Training, support, and device provision from a single source.
- Automated data collection
- Less on-site effort & costs
-
Faster
analyses & decisions
More precise
efficacy & safety evidence
- For temperature-sensitive endpoints
- Precise time-to-onset & time-to-effect
- Clear differentiation of fever causes
- Continuous instead of isolated data
- Precise temperature & treatment profiles
- High data integrity without measurement errors
- Lower monitoring costs
- Shorter study durations
- Higher compliance & better ROI
- FHIR/HL7, eCRF & CDISC-compatible
- Centralized monitoring via dashboard or API
- Scalable packages & full-service support
For more detailed information, please switch to the desktop version or schedule a consultation.
FAQ About SteadyTemp Studies
What data formats does SteadyTemp provide for study evaluations?
SteadyTemp exports temperature curves, including entries, as a PDF. SteadyTemp Professional transmits temperature data in HL7/FHIR format as FHIR Observations to configured endpoints – standardized and encrypted.
Can SteadyTemp be used to detect postoperative temperature changes?
SteadyTemp supports the detection of temperature changes outside regular spot measurements. A clinical study on early detection of postoperative infections is available at: https://link.springer.com/article/10.1007/s10877-025-01383-y
How is data security ensured in study environments?
In combined use with the SteadyTemp Dashboard, SteadyTemp ensures secure, GDPR-compliant processing and encrypted transmission of all data. SteadyTemp Professional does not store any data locally and transmits all information exclusively to configured, closed network endpoints.
What measurement accuracy is relevant for study protocols?
The SteadyTemp system has a verified laboratory accuracy of ±0.3 °C according to EN ISO 80601-2-56. The measurement interval can be individually adjusted.
Is SteadyTemp approved as a medical device for clinical studies?
SteadyTemp is a CE-certified medical device. It can be used in studies where body temperature is captured as a primary or secondary endpoint.
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