The challenge

Speed defines success in clinical development. Participant recruitment constraints, lengthy dose-finding protocols, and device bridging timelines create critical delays leading to increased program costs and postponed patient access to new therapies.

Clear to Clinic

Benefits – accelerate, simplify, and de-risk your clinical program

Clear to Clinic enables the use of autoinjectors in clinical trials with clinic-ready devices and a coordinated supply path.

  • Rapid clinical supply
    Quick access to assembled clinic-ready devices with various dose configurations and placebo

  • Gain flexibility in study design and adaptations
    Design and adapt your study protocol with flexibility and confidence

  • Enable decentralized trials
    Use proven self-injection devices backed by ready-to-submit documentation

Approach – introduce YpsoMate in early clinical trials by
leveraging Ypsomed's platform performance data

Start with a clinic-ready YpsoMate or YpsoMate 2.25 with a proven technical baseline,
and customize your device for commercial launch leveraging Ypsomed's full design flexibility and streamlined scaleup.

Submission-ready documentation 3 months after clinical fill

  • Standardized device-related information for efficient trial submission and assembled clinic-ready devices delivered within 4 months of clinical fill

Multiple fill volumes/viscosities and drug product/placebo combinations

  • Flexible deployment of autoinjectors in clinical studies with possibility to adapt to changing study protocols

Comparable injection profile and user interface across clinical and commercial devices

  • Clinical performance data and documentation can be integrated for customized commercial devices

Coordinated supply path

Clear to Clinic is supported by preferred partners for final assembly, ensuring full traceability and quality control. Together, we provide a streamlined path into the clinic, reducing uncertainty and enabling earlier study initiation.

Meet our partners

Connect with CliniPilot

Combine Clear to Clinic with CliniPilot, Ypsomed’s digital data capture and automation solution, to enable real-time adherence tracking and data-driven trial optimization. Together, they create a connected solution that integrates into EDC platforms for efficient clinical studies.

Learn more about CliniPilot

Proven platform. Proven partner.

Clear to Clinic builds on the commercial success of YpsoMate and YpsoMate 2.25 – autoinjectors with a strong usability record and regulatory acceptance.

  • Devices validated in usability studies and market use
  • Proven device accuracy and reliability
  • Integrated partner network for assembly and packaging

External validation through the MIDBA study

Submitted to the European Medicines Agency (EMA), the Molecule Independent Device Bridging Approach (MIDBA) provides public recognition of a PK-bridging methodology demonstrated with data from YpsoMate and YpsoMate 2.25. MIDBA streamlines the clinical evidence required to register new drug-device combination products. MIDBA and the Clear to Clinic program reinforce Ypsomed's strong regulatory positioning and accelerate our partners' programs.

Resources & expert insights on Clear to Clinic

CliniPilot ODD article

Download the interview