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

Let’s Accelerate Clinical Development Together! Contact Us >>

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

Let’s Accelerate Clinical Development Together! Contact Us >>

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