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Directory of professional services

Investigators who initiate their own clinical trials may require specialized professional services to help them achieve the different stages of their projects. The lists below will help you find qualified resources in biostatistics, translation, regulatory affairs and monitoring.

Biostatistics

Several healthcare institutions offer biostatistical services to investigators who initiate their own clinical trials. Services are often offered to researchers from other institutions as well.

Translation

The translation of documents for clinical trials requires special expertise. The translators listed below specialize in the translation of scientific and medical documents.

Regulatory Affairs

Regulatory consulting firms provide coaching and support services, including communications with Health Canada, for example:

  • – when submitting clinical trial applications (CTAs) and clinical trial application amendments (CTA-As);
  • – when submitting adverse reactions reports.

Monitoring services (CRA)

Investigators who initiate their own clinical trials have the responsibility, as sponsors, to ensure that their trials are adequately monitored. The following companies and consultants have the expertise to monitor investigator-initiated trials.