Niche CRO Services

Pearl Pathways fully executes US-based clinical trials covering complex therapeutic areas and studies with sophisticated designs. Initiating, managing, monitoring, and closing out multi-site studies requires significant time and financial investments coupled with advanced clinical research expertise.

Pearl Pathways takes a leadership position for our clients by leveraging our clinical expertise to navigate clinical trials from study design to completion. Our involvement with the clinical research sponsor is a true partnership.

Our full-service niche CRO model integrates all aspects of trial service delivery seamlessly for our clients, providing a nimble, responsive, and efficient method for executing clinical research. Our CRO services are best positioned for in vitro diagnostic, medical device, or small-scale biopharmaceutical studies conducted across 50 or fewer US-based sites.

Pearl Pathways specializes in studies involving in vitro diagnostics, companion diagnostics, low-risk devices / delivery devices, CLIA waiver studies, combination products, human factors usability, phase zero studies, phase I and IV pharma studies, oncology, orthopedics, dermatology, and infectious disease.

Our niche CRO services cover:

Feasibility

• Determine optimal clinical trial locations
• Estimate patient enrollment
• Estimate screen failure rates

Study Start-Up

• Feasibility analysis and report
• Site identification, recruitment, and qualification
• Site contracts and investigator payments
• Investigator meeting planning
• Site regulatory document collection and management

Document Management

• Trial Master File (TMF)
• IRB documents
• Site related documents
• Training & communications between the site/CRO and CRO/sponsor

Project Management

• Overall study management
• Budget and timeline tracking
• Customized weekly, monthly, and quarterly reporting
• Vendor management

Clinical Trial Monitoring

• Site initiation, interim monitoring, and close-out visits
• CRA oversight
• Site management
• Query resolution
• Clinical site coordinator support

Regulatory Affairs Management

• Regulatory applications and submissions
• Clinical quality assurance audits
• Trial master file (TMF) and electronic management
• Strategic regulatory guidance and FDA representation
• Tactical regulatory support

Clinical Data Management and Biostatistics

• Trial design and sample size calculation
• CRF/eCRF design and EDC management
• Statistical analysis and programming
• Randomization and IWRS
• Medical writing

Safety

• Pharmacovigilance
• Medical monitoring
• Data Safety Monitoring Boards (DSMB)
• Comprehensive case management

Quality Assurance Services

• Internal audits/assessments
• External audits/assessments
• Preparation for FDA audit