Medical Writing

Medical writing at Intertek Cantox encompasses everything from nonclinical peer reviewed manuscripts, through regulatory submissions and clinical documents. The combination of diverse scientific knowledge and extensive development experience is brought together to produce clear and concisely worded documents for our global clients.

Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of documents that address the needs of various audiences, including clinical investigators, IRBs, medical monitors, study coordinators, and regulatory reviewers.

The Intertek Cantox team can assist with all nonclinical and clinical Associated Regulatory Tasks including:

• Investigator’s brochures, including first-in-human to late-stage drug-development brochures
• Product Monographs, Package Inserts, etc.
• Phase 1 through phase 4 clinical study protocols and amendments
• Write or review clinical study reports, (phase 1 through phase 4)
• Position nonclinical safety data and findings to clinicians
• Nonclinical or Clinical interim data summaries
• Preparation of nonclinical and clinical sections for Module 2
• Preparation of IND annual reports
• Data and safety monitoring board reports
• Prepare SAE reports for submission to all required authorities, IRBs, Agencies
• Positioning of scientific information for Orphan and Fast Track Applications
• Write and maintain Targeted Product Plan (TPP)