Phase II study on Acne (2018). Small/medium size sponsor needs to produce reliable and high-quality data on IGA score, primary endpoint requested by regulatory agencies. Ethical designs a streamlined and integrated process thanks to the flexible integration with EDC tools.
CLIENT
Sponsor (small/medium size)
DISEASE AREA
Dermatology (acne)
STUDY INFORMATION
Phase II
Executed in Europe
6 countries – 35 sites – 400 subjects
YEAR INITIATED
2018
REQUIREMENTS
- Set up an adjudication procedure to ensure consistency and quality of the acne assessment across study sites at the request of Regulatory Agencies’
- Collect photos from sites (5 photos including first and last visit), control anonymization centrally, submit to blinded central reviewers and collect assessments
- Compare blinded assessment with investigators’ IGA assessment and share results with sponsor
ETHICAL’S SOLUTION
- The end-to-end data management with integrated QC was possible thanks to the flexible integration of Ethical’s eAdjudication® and EDC tools (IWRS, e-CRF)
- The creation of events in eAdjudication® was automated based on e-CRF data
- The use of an iPad application made it easy for sites to upload photos
- The automatic comparison of assessments with alerts on disagreements and site scoring allowed the sponsor to correct possible misunderstandings or poor quality at the study site
CUSTOMER FEEDBACK
“This study represents the first time ever use of central adjudication in Acne Drug Clinical Development. Our objective was to produce reliable and high-quality data on IGA score, primary end point requested by Regulatory Agencies. Ethical staff proved to be very responsive in understanding our Quality Control needs and to design a streamlined and integrated process based on their Clinical Data Management Software Solutions.”
eADJUDICATION®: COMPLIANT AND COST-EFFECTIVE ENDPOINT ADJUDICATION COMMITTEES MANAGEMENT
eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.
