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