• Number of Studies Conducted: 3
• Client: Indian Sponsor
• Requirements: Client approached D2L to provide about (5+2+5) pediatric sites for 3 studies
• Site feasibility was based on
  • Experienced Sites
  • High Birth Rate
  • Patient Recruitment - Avg. recruitment of 70 subjects/month
  • Turn around time for getting EC Approvals

Highlights of D2L Support

• Identified and provided the required sites in each of studies with less than a week of turn around time
• Conducted Pre Site Selection Visit (PSSV) to Identified Sites
• Developed Infrastructure at each site
• EC submissions completed within two weeks
• Assisted in getting faster approvals from the ECs
• Provided Protocol Specific Training to Investigators & CRC’s at each sites
• Achieved the target subject recruitment within 25 days
• Internal pre-monitoring visits from D2L to each sites ensured high quality & subject retention
• Drop- Out Rates – less than 5 %
• Three sites successfully audited by the Sponsor