Clinical Operations

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TRiNDS Clinical Operations offers trial management solutions throughout all stages of a clinical trial and for Phase I through Phase IV (post marketing). TRiNDS Clinical Operations has a dedicated and passionate team of project managers with specialized neuromuscular clinical trial management experience. The team provides comprehensive oversight for protocol design, protocol feasibility, overall protocol compliance and monitoring. As the official Coordinating Center for CINRG, TRiNDS also runs the independent CINRG Data and Safety Monitoring Board (DSMB).

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Every project is assigned a Clinical Trial Manager who leads the overall execution of the project

Project Start-up

  • Study feasibility
  • Site identification and qualification with full access to the CINRG consortium
  • Investigator meeting
  • Site regulatory document collection and management through Clinical Conductor (CTMS) which is integrated with OpenClinica Data Management solutions

Project Management

  • Overall study management
  • GCP training and compliance
  • Site contracts and budgets
  • Timeline tracking with customized reporting
  • Vendor management

Clinical Trial Monitoring

  • Clinical site support and management
  • Study enrollment reporting
  • Site initiation visits
  • Interim monitoring visits
  • Close-out visits
  • Query resolution coordinated with Data Management solutions or data management vendor

Regulatory Affairs

  • Ethic submission support
  • Central regulatory submission
  • Support for FDA, EMA and other relevant agencies
  • Trial master file (TMF) management
  • Domain specific regulatory guidance