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What We Do

Operations/Study Management

TRACE personnel work with principal investigators during protocol design and development. Study management and coordination is centralized and overseen by a dedicated team including implementation of trial specific operations, clinical site start-up and monitoring of trial conduct from activation to close-out.

Validated EDC, Randomization and Clinical Trial Management Systems

TRACE uses internally developed and validated systems for its clinical trials. The systems are compliant with global regulatory requirements, including 21 CFR Part 11. The systems include:
  • Registration/randomization System
  • Drug inventory System
  • Clinical Trial Management System (CTMS)
  • Electronic Data Capture (EDC) System
  • Safety Data Tracking System

Biostatistics and Methodology

Our clinical trials benefit from the expertise of faculty biostatisticians who are specifically assigned to support individual trials. The biostatisticians ensure appropriate methodology and analytical approaches are implemented to generate reliable results.

Financial and Contract Management

Our financial and contract management services are integrated with McMaster University Health Research Services to provide support including specialized clinical trial agreement negotiation, comprehensive study budgeting, and automated site payment systems that ensure accurate, timely financial administration throughout the trial.

Regulatory Services

Our regulatory services encompass the full spectrum of trial support, from regulatory submissions (e.g. Health Canada) to informed consent development. As an approved academic sponsor, we facilitate REB submissions, while providing centralized medical monitoring through our SAE safety desk.

Data Management

Our comprehensive data management services encompass database design and build, electronic data capture system implementation, data monitoring, and systematic quality control processes. We maintain rigorous data validation protocols, conduct regular data cleaning activities, and ensure full audit trail documentation to guarantee data integrity.