Feasibility Studies
Feasibility Studies
Trail-blazing study designs that validate device safety and performance early, incorporating adaptive methodologies to accelerate proof-of-concept while minimizing patient exposure and study costs.
Pivotal Trials
Pivotal Trials
Evidence-based pivotal study protocols engineered for regulatory success, featuring patient-centric endpoints and streamlined data collection that supports compelling 510(k)/ or PMA submissions and/or CE Marking.
Post-Market Surveillance
Post-Market Surveillance
Strategic post-market surveillance study designs that satisfy regulatory requirements while generating safety and performance data for ongoing compliance and continuous improvement.
IVD Clinical Studies
IVD Clinical Studies
Specialized in vitro diagnostic clinical evaluation protocols that meet FDA and CE marking requirements, optimizing study populations and statistical approaches for device-specific performance validation.
Real-World Evidence
Real-World Evidence
Patient-centric real-world evidence study designs that capture meaningful clinical outcomes in routine care settings, supporting regulatory submissions and payer value demonstrations.
Optimizing Protocol Design and Execution Without Compromise
Situation
A computational ECG mapping system for FDA clearance in a 510(k) submission. Sponsor needed guidance on design and endpoint identification.
Successes
- Revamped study design to use least burdensome approach and optimize endpoints
- Extracted high-volume enrollment through strong relationships with KOLs and sites
- Ran a nimble, quality-first study with data pushing them to take 1st position in market share
Services by Veranex
- Study Design & Optimization
- Study Management & Monitoring
- Safety Management
- Data Management
- Biostatistics
- Medical Writing
Clinical Trial Management
Clinical Trial Management
End-to-end clinical trial execution that transforms your evidence-backed protocols into regulatory-grade data packages.
Real World Evidence
Real World Evidence
Patient-centric real-world evidence strategies that strengthen your regulatory submissions and unlock reimbursement pathways through compelling clinical outcomes data.
EU MDR Consulting
EU MDR Consulting
Smart compliance strategies that accelerate CE marking timelines while ensuring your clinical evidence package meets notified body expectations.
FDA Consulting
FDA Consulting
Evidence-based FDA submission strategies that fast-track 510(k) and PMA approvals through regulatory intelligence and submission optimization expertise.
