Niche CRO Services

Full service, Boutique Clinical Research Services

We at Pearl Pathways take pride in accelerating our clients’ clinical programs through our niche clinical research services. Pearl Pathways supports all types of clinical trials covering complex therapeutic areas and studies with sophisticated designs. A lot can go wrong during a trial that can cost a company significant time and money, and we will support you when things go wrong. However, our staff will not just fill in the gaps; we will help your team work smarter and more efficiently. Our accomplished advisors will customize an approach to meet the specific clinical program for your biopharmaceutical, device, or diagnostic while building strong relationships with your team to drive value.

Our niche CRO services cover:

Global 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