Medical Writing Services Include:
Phase I-IV protocol development
Case Report Form design
Regulatory applications and submissions
Phase I-IV integrated clinical statistics reports
Clinical study reports according to ICH E3 and eCTD format
Translations of regulatory documents
Investigator's brochure development
Informed Consent Form including local language ICFs (prepared and reviewed by the relevant country)
Case narratives
SOP development
Leaflets, buclets and posters
Serious adverse event narratives
Pre- and post-approval aggregate safety reports
Our partners
