Niche CRO Services
Full-service, boutique clinical research 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