Success Story

Meeting Timelines in a Small Patient Population for a Rare Disease

Situation: A Phase 2 orphan drug study

The Success: During a challenging Phase 2 study with a small patient population using visual analog scales, diary data, and patient workbooks, we were able to meet all timelines and exceed sponsor expectations by:

  • Maintaining strong relationships with the sponsor and sites
  • Utilizing support groups to assist in referral and recruitment efforts
  • Selecting experienced, high enrolling sites
  • Utilizing previous experience in both the therapeutic area and with diseases with small/special populations