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Dermatology case study: Global Phase III Studies – Psoriasis

After a case study about autoimmune, inflammatory & skin diseases, Kayentis publishes its last case study specifically focused on dermatology and the global phase III studies in psoriasis.

Global Phase III Studies – Psoriasis

  • 6,000 patients
  • 1,000 sites
  • 60 countries
  • Adults, elderly and pediatric populations.

Challenges of the dermatology case study

  • At the beginning of the program, the sponsor switched from paper COA to electronic COA for adult, elderly, and pediatric populations
  • Inclusion of countries worldwide
  • Technology/device adapted for ePRO and ClinRO requirements
  • Need to obtain PASI Score immediately
  • Short data management timelines.

Frédérique MARION, Kayentis Business Development Director – February, 27, 2017

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 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’s dual connectivity (3G/WiFi), which allowed immediate transmission and synchronization at any time and 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

Worlwide 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, 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

Real-time reporting – Instant score available

  • The use of the tablet was key to increasing data quantity and improving data quality; the configuration that allowed the clinician to review patients’ data was particularly useful in minimizing missing data and errors
  • The tablet’s 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 calculated instantly, transmitted, and available immediately 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 eCOA compliance and the 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 signals of sites’ behaviour/understanding
  • – The KPIs were followed; pre-analysis was 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 set-up & database lock timeline
  • Establishing working process and implementing improvement for the set-up of new studies resulted in time efficiencies and cost savings. Overall these benefits ensured a continuous and successful collaboration between Kayentis, the sponsor, and linguistic translation/validation vendors

Last update : 12 January 2018

Agenda

  • 22 October
    OCT Nordics - Oct 22&23 - Copenhagen, Denmark - Booth #10 - Schedule a meeting with Kayentis
  • 02 November
    ISPOR - Nov 2-6 - Copenhagen, Denmark - Schedule a meeting with Kayentis   ISPOR
  • 10 November
    DIA Japan 2019 - Nov 10-12 - Tokyo Big Sight, Ariake - Booth #42 -  Schedule a meeting with Kayentis
  • 19 November
    DMB - Nov 19 - Paris, France - Booth #14 - Schedule a meeting with Kayentis
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