Clinical trials support

Access clinical trial support services throughout the lifecycle of your research project

WCHRI’s award-winning clinical trials support team helps minimize the time required to initiate studies by facilitating regulatory requirements and ensuring that women and children who choose to participate in research receive the best care by experienced staff. We have expertise working with industry-sponsored as well as investigator-initiated clinical trials and can manage all aspects of the study as per protocol, under the guidance of the principal investigator (PI).

Study planning and start-up

  • Assistance with feasibility form 
  • Review of protocols and budgets 
  • Site evaluation and site initiation visits
  • Submission and tracking of contracts and agreements 
  • Negotiating budgets with sponsor or contract research organization (CRO)
  • Assistance with clinical trial applications to Health Canada (in conjunction with the Quality Management in Clinical Research (QMCR) office)
  • Preparation of source documents
  • Preparation and submission of regulatory documents to sponsor
  • Preparation of ethics submission, including consent revision
  • Facilitating operational and administrative approvals

Study conduct and closeout

  • Screening, recruitment; participant consent, assent and visit scheduling
  • Administering questionnaires, data collection, sample collection, data entry
  • Managing regulatory documents and annual ethics renewals
  • Reporting on adverse events
  • Coordinating lab and other ancillary services
  • Administrating study medications, compliance teaching, compliance monitoring
  • Assisting with study close-out and archiving study documentation

Additional information

For more information and to access any of our services, complete the research support request form.