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Case Studies

At Confidence, we don’t just manage studies — we solve operational challenges that others cannot. From first-in-human programs to large-scale global enrollment initiatives and complex rescue situations, our physician-led teams combine feasibility intelligence, site engagement, and real-time oversight to deliver measurable results.

These case studies highlight how strategic execution, operational agility, and deep medical leadership translate into accelerated timelines, restored sponsor confidence, and successful study outcomes across therapeutic areas.

Migraine Study

Patients
0
Months
0

Background & Challenge

Migraine studies are often challenging because of strict diagnostic criteria, variable screen-failure rates, and inconsistent site readiness. Based on historical benchmarks, projections estimated 6–9 months would be needed to complete enrollment.

Confidence’s Approach

  • Conducted a feasibility re-assessment to validate site capabilities.
  • Engaged investigators early with education on patient pathways and inclusion/exclusion criteria.
  • Deployed a site-support task force dedicated to prescreening and patient outreach.
  • Implemented real-time enrollment dashboards to track progress across regions.
  • Impact

Enrollment was completed in just 3 months, with 400 patients enrolled — cutting the projected timeline in half and accelerating data delivery for the sponsor.

Vaccine Study (FIH, US Phase 1)

Patients
0
Months
0

Background & Challenge

First-in-human vaccine studies are highly complex. They require rapid site start-up, regulatory approvals, and patient recruitment under tight timelines. Industry averages suggest 8–12 weeks from start-up to first patient in.

Confidence’s Approach

  • Parallelized IRB submission, contracting, and site start-up activities.
  • Engaged experienced US Phase 1 sites with proven vaccine expertise.
  • Built pre-identified patient cohorts ready to enroll once approvals cleared.
  • Used a single-point monitoring team for rapid data validation.
  • Impact

3 weeks from green light to site activation. 60 patients fully enrolled within 1 month. Study completed faster than comparable programs in the same space.

Biomarker Oncology Study

Patients
0

Background & Challenge

Biomarker-driven oncology trials require screening vast numbers of patients across diverse geographies, with complex data flows and logistical hurdles. Few CROs can scale to thousands of patients while ensuring data quality.

Confidence’s Approach

  • Established a global biomarker screening network across multiple continents.
  • Centralized data-management hubs to unify disparate datasets.
  • Standardized electronic workflows for rapid sample tracking and reporting.
  • Engaged sites with dedicated oncology support teams to reduce administrative burden.
  • Impact

Successfully completed enrollment of 5,000 patients.

Rescue Study – Infectious Disease

Antibiotic
0 Phase

Background & Challenge

The original CRO had only enrolled 120 patients in 2 years in a critical global Phase 3 infectious disease trial. Timelines were slipping, risking regulatory and financial setbacks.

Confidence’s Approach

  • Conducted a feasibility re-assessment to reallocate resources to higher-performing regions.
  • Launched site engagement task forces to reinvigorate underperforming centers.
  • Deployed risk-based monitoring to streamline oversight without sacrificing quality.
  • Created regional “rescue task teams” to accelerate contracting and patient outreach.
  • Impact

Confidence enrolled 400 patients in 1 year — tripling prior enrollment pace. Reestablished sponsor confidence in trial timelines and put the program back on track for regulatory submission.

Complicated Intubation 
Device Study

First-in-
Human

Device

Background & Challenge

First-in-human device studies are pivotal moments where safety, feasibility, and usability must be proven quickly. For a novel intubation device designed for complex airways, timely enrollment was critical to validate the concept and move development forward.

Confidence’s Approach

  • Partnered with leading anesthesiology and critical care centers experienced in complex intubation.
  • Delivered tailored investigator training programs pre-study.
  • Streamlined eligibility and case documentation workflows.
  • Used a rapid feedback loop with investigators to resolve barriers in real time.
  • Impact

Full enrollment completed in just 2 weeks. Device feasibility successfully demonstrated with high investigator satisfaction. Sponsor obtained rapid proof-of-concept data to guide the next development phase.