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.
Rare Autoimmune Disease Study
Background & Challenge
Confidence joined a global early-phase study of a novel immunomodulating therapy for autoimmune cytopenias nearly one year after recruitment had begun. The warm autoimmune hemolytic anemia (wAIHA) cohort faced particularly slow enrollment due to the rarity of the disease, restrictive eligibility criteria, and operational complexity.
Confidence’s Approach
- Accelerated site activation, with 80% of sites activated within 60 days.
- Introduced bi-weekly investigator touchpoints and 24/7 Medical Monitor support for real-time eligibility discussions.
- Used structured investigator feedback to identify enrollment barriers and support targeted protocol refinements.
- Established centralized medical and data review for closer oversight of patient safety and eligibility.
- Developed a customized tracking tool to manage 22 laboratory kit types across multiple laboratories.
- Impact
Across Confidence-managed sites, the wAIHA cohort achieved an actual enrollment rate of 0.04 subjects/site/month versus 0.011 expected, approximately 3.6× the projected rate. Confidence-managed sites ultimately enrolled the same number of wAIHA patients as the rest of the global network combined, in approximately half the time.
Knee Osteoarthritis Study
Background & Challenge
This Phase III randomized, double-blind, placebo-controlled study evaluated an investigational modified-release formulation of ibuprofen 800 mg in patients with chronic pain associated with knee osteoarthritis. The study required recruitment of patients with established osteoarthritis and consistent pain symptoms, along with standardized assessment of pain, physical function, and treatment response. Confidence managed the U.S. portion of the study while coordinating closely with an Asia-based CRO, adding a cross-regional operational component to study execution.
Confidence’s Approach
- Engaged sites with established access to osteoarthritis patients and experience conducting outpatient pain studies.
- Worked closely with the partner CRO to align study processes, communication pathways, and operational expectations across regions.
- Maintained regular communication with sites and investigators to support recruitment, monitor progress, and address issues promptly.
- Provided experienced CRA and project leadership to support consistent oversight, protocol compliance, and data quality.
- Impact
Confidence successfully managed the U.S. portion of the 400-patient study, meeting enrollment objectives while maintaining protocol compliance and data quality. Close coordination among sites, investigators, and the international CRO partner supported smooth study execution and alignment across stakeholders.
STEMI Study Phase 3 Cardiovascular Study
Background & Challenge
STEMI Study was an international, multicenter study evaluating a pharmaco-invasive strategy in patients aged 60 years or older presenting with ST-segment elevation myocardial infarction (STEMI) within 3 hours of symptom onset when timely primary PCI was not feasible. The study required coordination across emergency medical services, community hospitals, and PCI-capable centers, creating significant operational and logistical complexity.
Confidence’s Approach
- Provided operational leadership, with Confidence team members serving on the study’s Operations Committee.
- Assigned physicians to key study roles, including Global Project Manager and Lead CRA.
- Supported country and site selection through prior experience and feasibility assessments.
- Established close communication with National Coordinators, investigators, and KOLs.
- Maintained zero CRA turnover throughout 4 years of enrollment, supporting continuity across the study.
- Impact
The study successfully enrolled patients across 10 countries while navigating the operational complexities of emergency cardiovascular research. STEMI Study contributed important clinical evidence on the use of a pharmaco-invasive strategy when timely primary PCI is not feasible.
Migraine Study
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)
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
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
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.