Trial Management

Stark Associates trial management services provide clinical project planning, clinical operation, monitoring and project management services. We offer either full service or stand-alone services. Our highly efficient team is committed to provide innovative customised solutions by offering quality and reproducible data deliverables with special emphasis on data integrity, speed and accuracy. We believe in pushing our quality limits by staying abreast of emerging technologies, adapting to regulatory changes, process optimization for on time cost effective trial management services.

With strategic partnerships with vendors, we provide a broad range of customised functional trial management solutions:

Clinical research strategy and planning
Clinical study report writing
Clinical monitoring and operations
  • Protocol design and clinical development plans
  • Study specific training
  • Risk based monitoring services
  • Identifying and mitigating key risk indicators
  • Analyse trends in safety and efficacy
  • Review the clinical study reports
Study management
  • Site identification and feasibility
  • Site selection and qualification
  • IRB / EC approval
  • Subject recruitment
  • Central lab services
  • Clinical supply management
Quality assurance
  • Study compliance
  • Process verification
  • Vendor oversight
  • Regulatory services
Data management
  • eCRF and pCRF design
  • EDC capability
  • Case report form and database design
  • Adverse events reporting and SAE reconciliation
  • Data validation
  • Data discrepancy management
  • Database lock
  • Comprehensive CDISC services
  • Archiving