Physician-researchers who initiate their own clinical studies 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.
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.
The translation of documents for clinical trials requires special expertise. The translators listed below specialize in the translation of scientific and medical documents.
Regulatory consulting firms provide coaching and support services, including communications with Health Canada, for example:
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.
Canadian regulation requires that every aspect of a clinical trial be supported by a quality management system. Moreover, electronic systems (e.g. eCRF) must be validated to ensure the reliability of research results. The companies listed below design and implement risk-based quality management systems, perform quality audits, and validate electronic systems used in clinical research.
917, rue Monseigneur-Grandin,
bur. 300, Québec (QC) G1V 3X8, Canada