Medical Writing


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Medical Writing

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row full_width=”stretch_row”][vc_column][vc_row_inner gap=”30″ el_id=”desktop”][vc_column_inner width=”1/3″][vc_wp_custommenu nav_menu=”4″][/vc_column_inner][vc_column_inner width=”2/3″ css=”.vc_custom_1659718777960{margin-top: 25px !important;}”][vc_column_text]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

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

[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner gap=”30″ el_id=”mobile”][vc_column_inner width=”2/3″][vc_column_text]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

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

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Let’s Connect!

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