Management Of A Large And Complex Study In Rheumatoid Arthritis With EDC Solution

This case study illustrates Chiltern’s in-house expertise in EDC and close collaboration with the study monitors ensured that this complex and large global project was concluded on time.

Project Overview

• A Phase IIIb, multi-national, open-label single-arm study with a treatment period of 24 weeks. The services provided were project management, data management, medical monitoring, pharmacovigilance and clinical study report.
• Primary objective was to assess the safety and tolerability in patients with moderate to severe active Rheumatoid Arthritis (RA).
• Collaboration with EDC vendor Oracle InForm.
• Study duration – 32 months.
• 1,993 enrolled patients.
• Sites and participating countries – 267 sites in Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, UK.

Project Challenges

• Management and database lock of high volume of data from 26 countries, 267 sites and almost 2,000 patients.
• The complex study required front end integration of Central Labs data into the electronic Case Report Form (eCRF).
• Significant changes to eCRF design due to protocol amendments.
• The inclusion of long term extension study visits within the same eCRF.
• Study coding to be performed outside the eCR