Medical Writing

A successful and on-target clinical trial must be supported by an extensive research plan and result in documentation that is both coherent and presents clinical data to the highest ethical and scientific standards. TCA is dedicated to delivering medical documentation that is free from inaccuracies. What's more, our expertly trained team of medical writers brings a broad range of academic, pharmaceutical industry, clinical research and scientific experience and can quickly adapt to any changes in the scope of the trial research or time-lines.

TCA can provide the following documents which are all intensely assessed from a statistical, scientific, quality control and editorial standpoint:
  • Clinical development plans
  • Protocols
  • Clinical study reports
  • Clinical sections of common technical documents (CTDs)
  • Clinical sections of new drug applications (NDAs)
  • Abstracts, manuscripts, and journal articles
  • Investigator brochures and annual updates
  • Informed consent forms
  • Periodic safety update reports (PSURs) and other pharmacovigilance documents
  • Pre-FDA meeting briefing documents
  • Response to clinical hold orders
  • Preclinical study reports, expert reports, and summaries
  • Data safety monitoring board (DSMB) manuals
  • Written and tabular summaries
  • Benefit/risk assessment reports
  • Medical and scientific literature reviews