Signant Health: The Evidence Generation Company TM

Precision, Speed, Scale:
Transforming Vaccine Trials

When the world is counting on you to deliver your vaccine, count on us to help you navigate the complexities of large-scale, multinational vaccine trials. 

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From COVID-19 to RSV trials, sponsors and CROs rely on our combination of best-in-class technology, scientific leadership, global scale, and mature services to assist in all phases of vaccine clinical development. 

In addition to expertise in eCOA, RTSM, eConsent, Telemedicine, and Patient Engagement solutions, we empower long-term vaccine trials with experienced implementation teams who deliver on-time and at-scale, including long-term disease surveillance and meeting seasonal incidence milestones. 

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Unrivaled Experience
in Vaccine Trials

Experience matters –
trust Signant to deliver, for every vaccine trial.

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200+
Vaccine Studies


525,000+
Participants

8,000+
Sites


2,000+
ePRO Studies


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Comprehensive eClinical Solutions

Our industry-leading Signant SmartSignals® products and services provide comprehensive solutions for modern vaccine research. Whether collecting primary safety data, conducting long-term incidence surveillance, managing global medication supply chains, or ensuring simple and engaging participation for participants, our leading solutions deliver precision and speed, at global scale.

  • eCOA
  • RTSM
  • eConsent
  • Telemedicine
  • Patient Engagement
  • eCOA

    eCOA (Electronic Clinical Outcome Assessment)

    • Proprietary standard reactogenicity diary instrument with adult and pediatric versions
      • Configurable item bank for clinical signs and symptoms, including temperature, injection site reactions, and overall health indicators
    • Long-term disease surveillance diaries to drive accurate efficacy evaluation
    • BYOD (Bring Your Own Device) options: app or web-based, with partial or full device provisioning
    • Proven high completion rates for reliable evidence.

  • RTSM

    RTSM (Randomization and Trial Supply Management)

    • Scale to handle high numbers of patients randomized rapidly
    • Medication management algorithms tailored to vaccine research, including:
      • Dynamic adjustment of site re-supply thresholds based on real-time screening data
      • Flexible medication usage rules (e.g., single or multiple participants per vial)
      • Split shipment management for frozen and non-frozen supplies
    • Seamless adaptation for multi-phase designs

  • eConsent

    eConsent

    • Rapid implementation solution (pdf) for studies with simpler consenting requirements
    • Remote access for participants to review consent forms ahead of site visits, to speed on-site consenting
    • Streamlined reconsent process for ongoing studies

  • Telemedicine

    Telemedicine

    • Simplify long-term participant follow-up for disease incidence surveillance

  • Patient Engagement

    Patient Engagement

    • Guide the participant journey using up-to-date visit schedules, with clinic visit reminders and alerts to improve adherence to study protocols
    • Provide participants with on-demand access to study information throughout the trial

Why Signant

  • Proven expertise in managing large-scale, global vaccine trials

  • Tailored solutions to meet critical milestones and seasonal disease timings

  • Robust processes to support interim analyses and regulatory submissions

  • Global logistics team capable of rapidly distributing devices across the globe

  • 24/7 multilingual patient support helpdesk

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Partner with Signant Health to navigate the complexities of vaccine trials and generate the reliable, high-quality evidence needed to bring your vaccine to the public quickly and efficiently.