Medical Writing

Our Medical Writers are capable of handling end to end complex writing services, thus supporting in accelerating product LABEL approval from Health Authorities.

Services We Offer:

For Individual Trials

• Clinical study reports (full, abbreviated)
• Informed consent forms and patient information leaflets
• Patient-level safety narratives

Aggregate Safety Reports (study or program level)

• Periodic safety update reports (PSURs)
• Periodic benefit-risk evaluation reports (PBRERs)
• US Food and Drug Administration periodic line listings
• Risk management plans (RMPs)
• Development safety update reports (DSURs)
• Signal analyses