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For Pharma

Specializing in clinical research services with a focus on oncology drug development programs.

SCRI Global Services is a division of the Sarah Cannon Research Institute specializing in strategic clinical research services with a focus on Phase I-III oncology drug development programs.

Relationships with the nearly 500 investigators affiliated with the SCRI strategic sites and the sites in the SCRI Oncology Research Consortium, along with investigators at sites outside the SCRI Network allow SCRI Global Services to offer sponsors access to a diverse and varied patient population spanning multiple tumor types and disease stages. These relationships further enhance the depth and bredth of therapeutic expertise of SCRI Global Services enabling it to provide focused, strategic operational support to ensure clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.

The following services are available as part of an integrated, full service, trial management program. Additionally, a subset of services may be selected.


Clinical Monitoring
  • Site qualification
  • Site initiations
  • Site monitoring
  • Site close-outs

Safety
  • Medical monitoring and safety surveillance
    -Collection and processing of SAE reports
  • IND safety reports
  • Notifications to regulatory agencies

Project Management
  • Project and study oversight
  • Timeline and budget oversight
  • Site and vendor management
  • Risk management and mitigation planning

Medical Writing

 

  • GCP document preparation including:
    -  protocols
    -  informed consents
    -  clinical study reports

Data Management
  • Full service capabilities for traditional paper-based and electronic data management
    (from CRF design to data lock)
  • External vendor data management (i.e., lab data
    transfer, reconciliation, etc.)
  • Validated systems under 21 CFR Part 11
  • Utilization of OmniComm

Quality Assurance
  • Comprehensive internal quality program
  • Oversight of all SOP's 
  • Oversight of all internal and external audits

Data Safety/Monitoring Board
  • Charter development
  • Member Selections
  • Ongoing management services

Biostatistics
  • SAS file provision in addition to quality support for statistical planning, analysis and reporting
  • Advanced statistical analysis, including multi-level analysis