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Pediatric Case Study: Global Phase II – Children and Young Adults

19 July 2018

Global Phase II study – Children and Young adults ePro ObsRo Oncology

  • 200 patients
  • 55 sites
  • 12 countries
  • 16 languages

Challenges of the Pediatric case study

  • An eCOA partner with expertise in pediatric populations that could deliver an ePRO solution
  • Technology/device adapted for combined ePRO and ObsRO requirements
  • On-site ePRO solution to ensure the best possible patient/caregiver compliance, and to simplify the process for all stakeholders
  • Effective interaction with the Sponsor and CRO to achieve short study set-up timelines

 

To download the pediatric case study, please click here:

Success Factors & Kayentis’ Solution

Easy-to-use solutions for all users and web platform for on-line reporting

Choose the most suitable device to match instrument specificities, investigator needs, and the patient/caregiver population – Simplicity

  • The Kayentis tablet was used for site-based ePRO/ObsRO data collection. The solution was judged by the users as simple to use, very intuitive, and seamless (the instrument was developed for use across age groups with an option to select the display according to the user’s age)
  • The portable tablet’s dual connectivity (3G/WIFI) allowed immediate transmission and synchronization at any time and place. This simplified process and improved flexibility were considered key advantages for the clinical staff
  • Data review tools on the tablet were indispensable for study site staff and the investigator to confirm that patient/caregiver answers for potential adverse events had been correctly reviewed at each visit
  • Moreover, powerful tools that allowed monitoring of the connectivity status for each tablet in real time were beneficial for accurate study site monitoring: immediate actions were taken remotely to resolve potential issues in a timely manner

Help desk support & key training

  • With the implementation of new technologies, a dedicated 24/7 multilingual Help Desk was provided to sites to ensure appropriate support for device use and questionnaire completion. The implementation of Key Performance Indicators (KPIs) with our Help Desk level 1 partner ensured a high level of site- and patient-satisfaction
  • Initiation training calls were provided by the Help Desk support for dummy patient training on device and tablets
  • In addition, Kayentis provided training at the investigator meeting and at CRO meetings to ensure appropriate online training of all stakeholders. As well as providing training directly in real time, a recorded version was also provided to facilitate refresher training or to provide internal training as required at a later date.

ClinForm – A web portal for on-line reporting

  • The use of our devices combined with the integrated web portal access allowed clinical staff and the study team to have immediate access to the study data and scores, and to monitor the study easily and in detail
  • Moreover, Clin’form can provide alerts to the site for specificePRO data for each patient as well as for external activity data that are transmitted
  • Our powerful data management tools allowed full data management of eCOA data as well as a high standard quality check and database reconciliation to ensure the high quality of a continuous, large volume of data

Efficiencies for the expedited management of study set-up

  • Early involvement with the Sponsor, proactive study management and effective collaboration with authors and translators for the generation of screenshots and training material in all required languages for IRB/EC submission
  • Established working processes and implementation of improvements for the set-up of new studies.Overall, these benefitsensured a successful collaboration between Kayentis, the Sponsor, and translators/validation vendors. This resulted in faster submission of eCOA documentation to IRBs/ECs, faster study implementation, and effective study management

Last update: 2018, July

Agenda

  • 30 October
    OCT Nordics - October 30th & 31st - Copenhagen, Denmark - Booth #10 - Schedule a meeting with Kayentis OCT Nordics 2018
  • 06 November
    OCT New England - November 6th & 7th - Boston, MA - Booth #46 - Schedule a meeting with Kayentis OCT New England
  • 13 November
    DMB Paris - November 13th - Paris, France Schedule a meeting with Kayentis  
  • 28 November
    PCT Europe - November 28th & 29th - Barcelona, Spain - Booth C61 Schedule a meeting with Kayentis
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