Challenges arise in any study and we are experts at utilizing our experience and innovative ways of thinking to turn any potential issue into an opportunity for success. Here are some examples:
Case Study 1
1500 patient, 25 site study with an infertility indication, DSP had no prior experience, but we met the enrollment goal 3 months early and filed the NDA 1 month early. How did we do it?
- Obtained IRB approval for sites prior to study meetings.
- Mandatory coordinator attendance at Investigator Meetings.
- Screening started one day after study meeting.
- Initiation visit was part of study meeting.
- Created competition among Investigators.
- Competitive grant payments.
- Weekly communications to sites.
Case Study 2
2000 patient, 125 site study with a women’s health indication. DSP had prior experience, and we leveraged that to complete screening 2 months early. The client was able to file the NDA 6 weeks early and save over $1.5MM from the overall budget. How did we do it?
- 150 sites evaluated and pre-studied in less than 60 days.
- 98% attendance at Investigator Meeting; 25 sites closed for non-activity within 4 weeks of meeting.
- Challenging goals: sites had to enroll at least 5 patients within 4 weeks of the meeting; sites only selected if regulatory documents were submitted within 10 days of receipt.
- Competitive enrollment and frequent communication regarding it.
Case Study 3
Saved sponsor $40K monthly ($960K total) in management and monitoring fees and increased enrollment timelines by 2 months for Phase III oncology study. How did we do it?
- Transferred study (US arm only) from large non-performing CRO to DSP within 30 days of contract award.
- Re-evaluated enrollment delays by closing non-performing sites and adding international sites.
- Streamlined contract and IRB delays with hospital/university sites by removing third party vendor.
- Developed monitoring plan to remove costly monthly visits to remote monitoring with 3 in-person visits per year.
- NDA successfully submitted within original projected timelines.
Case Study 4
Successfully completed challenging pain study, where DSP had no prior experience. The study was transferred from a non-performing CRO and we had 6 months to enroll with a placebo arm in a study with a marketed product. How did we do it?
- Changed CRF from electronic to paper to speed process.
- Offered open-label medication at study completion for all subjects.
- Competitive grant payments compared to other pain studies.
- Obtained IRB approval from 75% of the sites within 1 week of Investigator Meeting.
- Limited universities/local IRBs to 10% of total sites.