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Oncology Case Study: Global Phase III Oncology Study – Melanoma

With its strong experience in eCOA market, Kayentis introduces its new case study about oncology and melanoma in global phase III.

Global Phase III Oncology Study – Melanoma

  • 500 patients
  • 200 sites
  • 45 countries and languages
  • 36 months study duration

Challenges of this oncology case study

  • At the begining of the program, the Sponsor switched from paper COA to electronic COA
  • Solution required ePRO on-site requirements
  • 45+ countries/languages worldwide (including Japan, Thai, Greek)
  • Short study set-up timelines for the Full Package Protocol (FPP) submission -screenshots to be provided in all languages for faster IRB / Ethics Committee (EC) submissions.

Frédérique MARION, Kayentis Business Development Director

To download this case study, please click here:

Success Factors & Kayentis’ Solution

Choose the most suitable device to match instrument specificities, investigator needs, and the patient population

  • The Kayentis tablet was used for site-based ePRO data collection. Our solutions were judged as being simple to use, very intuitive, and seamless for all users
  • The tablet dual connectivity (3G/ WIFI) that allowed immediate transmission and synchronisation at any time and place at the local cost was considered a key advantage
  • Moreover, our powerful tools that allow monitoring of connectivity status for each tablet in real time were beneficial for the detailed monitoring of study sites: immediate actions were taken remotely to resolve potential issues in a timely manner

Expedite management of study set-up for preparation of the FPP

  • Proactive study management and effective collaboration with authors and translators for the generation of screenshots and training material in all languages for IRB/EC submission
  • Established working processes and implementation of improvements for the set-up of new studies; availability of assessment scales, previous experience, and knowledge of country specificities have in time efficiencies.
  • Overall these benefits ensured a successful collaboration between Kayentis, the Sponsor, and translators/validation vendors and resulted in faster submission of eCOA documentation to IRBs/ECs

Worldwide logistics support & training

  • Dedicated 24/7 multilingual Help Desk with 3 levels of escalation (English, German, Spanish, French, Italian provided as standard languages; over 150 additional languages on demand)
  • Investigator & CRA meeting training – local site initiation training – regular training and implementation of Key Performance Indicators (KPIs) with the Help Desk Level 1 partner to ensure a high level of site- and patient-satisfaction

Last update : 5 July 2020

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