Exactis’ team has extensive expertise and experience in the design, development and management of longitudinal biomarker based clinical trials, observational studies and real-world evidence projects.

What We Do

Work with Clinical and Translational Operation teams for protocol design and trial development. Our experience, combined with the expertise of the PICC, is available to study sponsors and represents a pan-Canadian perspective in shaping studies to be efficiently run across sites.

Our study start-up team will ensure that all pre-study activities are initiated promptly and efficiently including regulatory and ERB submissions, Investigator meetings, site initiation visits (SIVs) and vendor selection.

Our clinical data management team can develop and/or manage all your clinical data based on sponsor’s needs including paper or electronic case report form (eCRF) development, statistical analysis and data reporting.

An assigned Project Manager will build the optimal team for each trial while having a firm commitment to patients, clinicians and regulators.

Whether it is a pilot study or a phase II basket trial, we will communicate effectively with the study team and follow our proven SOPs for planning and execution, while executing the highest standards.

Our Services

  • Regulatory writing
    • Protocol development
    • Informed consent forms
    • Clinical Study Reports
  • Regulatory and ERB submissions
  • Study start-up
    • Site selection and qualification
    • Contract & budget negotiations
  • Study Management
    • Project Management
    • Monitoring
    • AE/SAE management
    • Electronic data capture system development (eCRFs)
    • Data Management