Ypsomed’s CliniPilot is an innovative add-on technology available in two versions, for YpsoMate 1 mL and 2.25 mL autoinjectors, transforming them into smart, connected devices, enabling connected clinical trials. It automatically captures and securely transmits key injection data—including time, date, injection outcome, and any identified user errors that may occur—via Bluetooth to a companion app. The app formats the data to be fully compatible with major Electronic Data Capture (EDC) systems and transmits it, ensuring that pharmaceutical partners retain full ownership of the data. Seamlessly embedded in current workflows, CliniPilot supports pre-approval trials and post-approval RWE programs across traditional, hybrid, and fully decentralized models. Developed in line with regulatory guidance without the need for regulatory clearance—enhancing flexibility, efficiency, and scalability.

Benefits for clinical trials

  • Seamless integration with EDC systems and existing workflows enables automated data transfer and enhances operational efficiency
  • Automatic data capture eliminates the need for patient diaries, along with associated human errors and manual documentation burden
  • Real-time adherence tracking, as well as detection and identification of user errors—minimized through digital guidance—help reduce protocol deviations
  • Captures real-world evidence to support regulatory approval and post-market insights
  • Developed in line with regulatory guidance without the need for regulatory clearance—enhancing flexibility, efficiency, and scalability

CliniPilot Device overview

  • Available in two versions, for YpsoMate 1 mL and 2.25 mL autoinjectors
  • Automatic injection data capturing
  • Real-time analytics
  • Optional acoustic and real time guidance
  • Detection and identification of use errors such as partial injection* or insufficient holding time*
  • Collects metadata from optional NFC-based smart label

Handling steps

1. Insert

2. Remove cap

3. Inject

4. Press button

5. Remove

Structured data capture for every injection

  • Captures injection data—time, date and injection outcome—automatically and in real time
  • Differentiates between successful and 9 different unsuccessful injection outcomes (due to user, hardware, software or smartlabel errors)
  • Distinguishes between different user errors (such as incomplete injection or holding time violations)
  • Checks drug-specific metadata (e.g., drug type, expiry date) via optional NFC SmartLabel
  • Captures device data (such as battery and connection status and serial number) for cybersecurity and maintenance reasons
  • Injection data owned and controlled by the pharmaceutical trial sponsor, not accessible or viewed by any third parties except clinical trial and CRO staff

CliniPilot: Seamless data integration into clinical trials

  • Seamless integration with existing clinical trial infrastructures without disrupting current workflows
  • Automatic Bluetooth® transfer of encrypted injection and device data to the participant’s smartphone — no user interaction required
  • Companion app formats injection data for compatibility with EDC systems, and transmits it via encrypted channels
  • Potential embedding into existing ePRO (electronic Patient-Reported Outcomes) app, enabling participants to self-report health outcomes—symptoms, well-being, or side effects—while CliniPilot data is captured and transmitted automatically in the background
  • Possible unification of the clinician workflow by integrating eCOA (electronic Clinical Outcome Assessment) data—including clinician-reported observations (site-based assessments) and participant self-reports (ePRO)—with real-time CliniPilot injection data; all data directly accessible through the EDC system
  • Device data is transmitted to Ypsomed’s Device Management Cloud, enabling proactive maintenance and robust cybersecurity throughout the device lifecycle
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CliniPilot: Empowering drug research & development

Pharmaceutical companies face growing pressure to accelerate drug development, reduce clinical trial costs and increase operational efficiency by easing the burden on both participants and study teams. CliniPilot empowers Drug Research and Development through the following three core capabilities.



Empower fully decentralized and hybrid clinical trials

CliniPilot supports remote participation by guiding patients and automating adherence tracking in real time.

  • Boost recruitment and retention by reducing patient anxiety and effort
  • Eliminates the need for manual diaries, reduces site visits and limits staff involvement
  • Easing the burden on both participants and study teams
  • Helping to identify user errors or missed doses early
  • Enables timely follow-up in case of deviations
  • Helps preserve participant data from being discarded in cases where protocol deviations would otherwise make it unusable

Enrich data quality

CliniPilot enhances data quality by automatically capturing precise injection data in real time, eliminating the need for manual or subjective input.

  • Reduces the risk of data loss and human error
  • Helps secure complete and consistent documentation for regulatory approval
  • Identifies and distinguishes user-related issues, such as partial injections or holding time violations
  • Optional NFC integration verifies drug authenticity by checking the drug type and expiry date

No added regulatory risk in clinical trials

CliniPilot builds on established platforms and is ready for use in clinical studies.

  • Based on the FDA-cleared SmartPilot platform
  • Shares SmartPilot's verified usability, safety and efficiency
  • Fully compatible with the YpsoMate platform, supporting both 1 mL and 2.25 mL autoinjectors
  • Low separate regulatory burden for clinical use
  • Requires no change to device design or existing clinical processes—ready to be used in clinical trials

Streamlined transitions from clinical to commercial

The same trusted device powers both commercial and clinical trial solutions, ensuring a seamless user experience and easy transition between clinical study and real-world use, but with key differences tailored to each setting.

Streamline clinical development with Ypsomed

Clear to Clinic

Clinic-ready devices to accelerate trial readiness and reduce study risk
No patient should see their therapy as harming the planet. Speed defines success in clinical development. Participant recruitment constraints, lengthy dose-finding protocols, and device bridging timelines create critical delays. Clear to Clinic enables the use of clinic-ready YpsoMate 1 mL and YpsoMate 2.25 mL autoinjectors in clinical trials to accelerate, simplify and derisk your program.

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Dimensions and specifications Facts and figures

Device specifications
  • DimensionFor YpsoMate® 2.25: 5.3 × 1.6 × 1.6 inches or 134.5 × 39.6 × 40.4 mm
    For YpsoMate® 1.0: 6.1 × 1.4 × 1.4 inches or 153.8 × 36.0 × 35.2 mm
  • WeightFor YpsoMate® 2.25: 61 g or 0.13 lb
    For YpsoMate® 1.0: 53 g or 0.12 Ib
  • TypeHandheld, reusable, non-rechargeable
  • Environmental conditions41 °F to 95 °F or + 5 °C to + 35 °C @ 15–90 % rH non-condensing within the atmospheric pressure range 700–1060 hPa
  • Ingress protection calssificationIP 20 as defined by IEC 60529
  • Intended usage lifetimeReusable without charging for up to 2 years or 120 injections after a storage period of up to 3 years
  • Data loggingSecured data storage for the captured injection data and device data
  • Feedback (User interface)*Real-time patient guidance using acoustic and visual feedback
  • CommunicationBluetooth® for the data transmission and the NFC for the pairing
  • Data securityTLS 1.3 end-to-end secured communication, sensitive data end-to-end ECIES encrypted
  • Smart NFC-based label*ISO 15693-compliant NFC reader for the SmartLabel of the YpsoMate®
  • Sensors and detection capabilitiesAutomated activation of the device with motion sensing.
    Detection of autoinjector presence.
    Inductive coupling detection of the injection status.

*Optional

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Resources & expert insights on CliniPilot

CliniPilot product brochure

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