Clinical Operations

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TRiNDS is a specialized contract research organization (CRO) leveraging experience in Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), Pompe Disease, and other neuromuscular disorders. TRiNDS Clinical Operations offers project and site management solutions throughout all stages of a clinical trial for Phase I to Phase IV (post marketing). TRiNDS Clinical Operations has a dedicated and passionate team of clinical trial specialists with neuromuscular and rare disease clinical trial management experience.

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

Project Planning

  • Establishment of timelines, budgets, and deliverables
  • Study and site feasibility
  • Risk identification
  • Vendor Selection

Project Initiation

  • Support for regulatory and ethics approvals
  • Site startup: selection, contracts, budgets, training and activation
  • Study document development

Project Execution

  • Site management including monitoring
  • Risk analysis and mitigation
  • Timeline and budget management
  • Customized milestone tracking and reporting through Clinical Trial Management System
  • Vendor management

Closing

  • Data cleaning
  • Site closeout
  • Document archival in Trial Master File (TMF)

Contact us today to learn how TRiNDS can support your development goals.