A forecast with a clear baseline
Our original feasibility estimate was 8 randomizations for this Phase 3 vitiligo study. That initial forecast remained the benchmark for measuring our enrollment delivery.
Phase 3 · Vitiligo
Enrollment beyond forecast. Audited with zero findings.
WCR randomized 15 participants against an original forecast of 8, exceeding the estimate by 87.5%. The site was sponsor audited with zero findings.
Explore the study storyStudy outcome
87.5%above the original randomization forecast15participants randomized
8original randomization forecast
0findings in the sponsor audit
Inside the case
87.5% above the original estimate
WCR randomized 15 participants, delivering 7 additional randomizations beyond the original forecast. The result demonstrates what our team delivered against a specific, measurable enrollment estimate.
Sponsor audited. Zero findings.
The site underwent a sponsor audit, which reported no findings. This adds a distinct quality outcome to the enrollment result for this study.
The participant follow-up picture
Of the 15 randomized participants, two were lost to follow-up and one withdrew early. Clear expectations and ongoing communication supported high compliance during active participation. Enrollment delivery, audit findings, and participant follow-up each remain distinct parts of this study’s performance.
The challenge. Our response.
Prepare for the criteria. Plan for the commitment.
Restrictive eligibility, vitiligo surface-area requirements, participant photography, and long procedure-heavy visits made preparation essential.
Restrictive eligibility and surface-area requirements
The challenge
Candidates had to meet restrictive inclusion criteria, including specific requirements for the extent of vitiligo involvement.
How our team responds
Our approach starts with focused pre-screening against the protocol requirements. We review potential eligibility and clarify the screening process before candidates commit to an in-person visit.
Participant photography
The challenge
Study photography added a personal consideration that participants needed to understand and feel prepared for.
How our team responds
We explain the photography requirement early, give participants time to ask questions, and discuss what to expect at the visit so they can make an informed decision about participation.
Long visits with multiple procedures
The challenge
In-person visits took substantial time and involved multiple study procedures, creating practical demands on participants.
How our team responds
We set clear expectations about visit length and procedures, plan appointments around participant availability, and keep communication open when scheduling concerns arise.
Study outcome
15 randomized. 87.5% above forecast. Sponsor audited with zero findings.
The participant experience
Enrollment is the beginning of the relationship.
Clear expectations before enrollment and open communication throughout participation supported high compliance with study requirements. Our team focused on building relationships that gave participants a familiar point of contact as the trial progressed.
Set expectations before screening
We discuss the study commitment early, including what participation will require and whether candidates feel ready to meet those expectations. Pre-screening helps establish a shared understanding before the first screening visit.
Build a working relationship
Participants need a team they can talk to. We build relationships throughout the study and keep communication open so questions and practical concerns can be raised with the site.
Keep the focus on follow-through
Our participant engagement approach continues beyond randomization. We stay connected throughout participation to support retention and compliance with study requirements.
Practical participant support
Help with the journey.
Support through the study.
We provide transportation support when needed to help participants attend study visits. We also discuss scheduling concerns early and maintain open communication throughout participation, helping address the practical barriers that can make follow-through difficult.
The result
15 randomized. 87.5% above forecast. Sponsor audited with zero findings.
Phase 3 · Vitiligo · WCR case study
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