Case Studies

An Accelerated Timeline Success Story: Phase II Dry Eye Study

Efficient execution is something that clients both large and small have come to expect from SDC. Our rigorous quality assurance practices, focusing on Six Sigma principles and continuous improvement ultimately lead to accelerated study timelines. The following is a recent example of the backend timeline results SDC strives to achieve on every project:

Case Details

• Phase II Dry Eye study with a clinical duration of over 6 months
• Approximately 230 subjects
• 6 sites in the United States
• Paper-based CRF with 80+ pages per subject
• Subject diaries

Key Highlights

• 23,963 pages including 900,000+ total data points were double data entered between CRFs and subject diaries
• Locked database less than 3 weeks after receiving final CRF (including critical variable and post-close audits)
• 5,500+ data discrepancies fully resolved
• Topline analysis delivered 3 business days after database lock
• Final analysis delivered less than 2 weeks after database lock