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Dermatology & autoimmune case study: an extensive eCOA experience in autoimmune, inflammatory and skin diseases

Kayentis has a strong eCOA experience in autoimmune, inflammatory and dermatology diseases, thanks to 5 years of successful collaboration with a Top 5 Pharma and more than 6 000 patients through 60 countries. Thus, the objective is to provide solutions for ePROs and clinROs assessment at site.

Challenges of the case study

At the beginning of the program, sponsor switched from paper COA to electronic COA. Moreover, adult, elderly, and pediatric populations were those concerned by the case study. The technology/device used was adapted for ePRO and ClinRO requirements of each country. Finally, we needed to obtain PASI Score immediately whereas the data management timelines were extremely short.

Frédérique MARION, Kayentis Business Development Director

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Success Factors & Kayentis’ Solution

The right device to match instrument specificities and the patient population

  • The Kayentis Tablet was used for site based eClinRO & ePRO data collection ePen technology was an alternative solution used for studies with older populations
  • Our solutions were judged simple to use, very intuitive, and totally seamless for all users
  • The Tablet dual connectivity (3G/WIFI) allowing immediate transmission and synchronization at any time and at the local cost was considered as a key advantage
  • Moreover our monitoring of the connectivity status for each Tablet in real time was beneficial for the close monitoring of the study sites: immediate remote actions were able to be taken to resolve potential issues in a timely manner

Worlwide logistics support

  • Dedicated 24/7 Multilingual Help Desk with 3 levels of escalation (English, German, Spanish, French, and Italian provided as standard languages; over 150 additional languages available on demand)
  • Regular training and implementation of KPIs with the Help Desk level 1 partner to ensure a high level of site and patient satisfaction

Instant PASI score available – Real-Time reporting

  • The use of the Tablet was key to increase the data quantity and quality, especially the configuration that allowed the the clinician to review patients’ data to help minimize missing data and errors
  • The Tablet dual connectivity (3G/WIFI) enabled the clinical staff and study team to have immediate access to the data. Once entered in the Tablet, the PASI score was instantly calculated, transmitted and immediately available on the Kayentis web portal
  • The use of the Tablet combined with the integrated Web portal access allowed clinical staff and the study team to monitor the eCOA compliance and eCOA study results easily and in detail

Proactive study management – Effective data management – Close relationships to ensure long-term collaboration

  • Implementation of study indicators to allow follow–up of study conduct: Follow-up of signals including weak signal of sites’ behaviour/understanding. The key performance indicators were followed; pre-analysis done by the Kayentis team and shared with the sponsor
  • Benefits of the Clin’Form platform were huge for the clinical staff and sponsor monitors: Real-time data access and instant scores/alerts. Query management and online queries for the investigator site
  • 100% on-time for setup & database lock timelines
  • Establishing working process and implementating improvement for the set-up of new studies resulted in time efficiencies and cost saving. Overall these benefits ensured a continuous and successful collaboration between Kayentis, the sponsor, and linguistic translation /validation vendors

Sponsor – Site survey

A survey showed excellent feedback from the sites and customers about our products and services, with a Net Promoter Score of >90%
  • 90% of end users judged our Tablet solution equal (40%) or superior (50%) to other Tablet solutions they had used before
  • Operational flexibility and a spirit of innovation
  • Expert team and senior management easily accessible
  • Competitive pricing

Last update : 25 March 2020

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