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Case Study

Norovirus Vaccine Study​

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
Case Study

Norovirus Vaccine Study​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
Case Study

Norovirus Vaccine Study​

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
Case Study

Norovirus Vaccine Study​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
Case Study

Norovirus Vaccine Study​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
Case Study

Norovirus Vaccine Study​

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

Download the PDF
Infectious Disease

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring
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Case Study

Norovirus Vaccine Study​

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

Infectious Disease
Download the PDF

Challenge

VaxArt needed solutions for evaluating the safety and immunogenicity of its orally administered norovirus vaccine. Of particular importance was incorporating a way to quickly detect severe reactogenicity symptoms during the first week following vaccine administration. ​

‍

Solution

  • Participants completed a daily diary via the ObvioHealth app, reporting the occurrence and severity of any of the predefined reactogenicity symptoms during the first 7 days.​
  • If a participant reported severe symptoms, an alert was immediately sent to the safety team for follow-up. Participants could also report any other health changes via the app for 4 weeks.
  • The site staff received alerts throughout the day if participants had not yet completed their diary. This allowed them to follow up while the patient was still within the window to complete the diary. ​

‍

Study Design

  • Hybrid
  • Site Partners
  • eConsent
  • Virtual Site Team (COACH)
  • ePRO
  • Remote Patient Monitoring

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