MEDICAL WRITING
Medical writers consultants ensure that clinical trial documentation is clear, concise, scientifically and medically accurate, and fully compliant with regulatory requirements.
Our consultant medical writers, all with a degree in medicine, have extensive backgrounds in most therapeutic areas.
Services include:
- Clinical development plans
- Phase I-IV Protocols
- Phase I-IV integrated clinical statistical report
- Abstracts, manuscripts, and journal articles (peer reviewed journals)
- Medical and scientific literature reviews
- Investigator brochures
- Informed consent form
- Patient safety narrativ
- Periodic safety reporting
Our Phase I-IV integrated clinical statistical reports also include accurate appendices according to the ICH or client’s guidelines. Clinical study reports can be consolidated into a single file and can be released electronically as Word or Acrobat PDF including hyperlinked table of contents or PDF bookmarks. |