For companies

  • I can write, review, or edit all types of documents required for approval. I am only satisfied when the result reads like a story.
  • I assist organizations in navigating through Health Canada requirements to obtain regulatory approval of their products or studies.
  • I work with the team in place to optimize processes, build templates, train new employees, write standard operating procedures (SOPs), and other internal tasks that have to be done but that are always difficult to prioritize.

For investigators

  • I ensure that investigators are aware of the Regulations that apply to clinical trials and submit clinical trials to Health Canada.
  • I help investigators to fulfill their sponsor responsibilities in investigator-initiated trials by reviewing and enhancing their internal quality processes.
  • I write clear and concise protocols to ease approval by the funding company, the ethics committee, and Health Canada which also help to avoid protocol deviations during the study conduct.
  • I assist in the writing of manuscripts to ensure the study results are communicated effectively.

“High quality work always delivered on time.”