Medical Writing

We offer Comprehensive, reliable medical writing support to expedite submissions and approvals. Our medical writing services are offered as an integrated part of our clinical development expertise and include Protocol development, ICF, Investigator Brochure, Clinical Study Report Writing, Regulatory Writing, Safety Documents.

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

Artboard 1 copy 2-100
Artboard 1 copy 3-100
Artboard 1 copy 4-100
Artboard 1 copy 5-100
Artboard 1 copy 6-100
Artboard 1 copy 7-100
Artboard 1 copy 8-100
Artboard 1 copy 9-100
Artboard 1 copy 10-100
Artboard 1 copy 11-100
Artboard 1 copy 12-100
Artboard 1 copy 13-100
Artboard 1 copy-100
Artboard 1-100

ul. Dzwonkowa 104

43-100 Tychy, Poland

+48 32 227 20 05


Al. Jana Pawla II

27 00-867 Warszawa, Poland

+48 32 227 20 05

©2020 Clinical Consulting. Privacy Policy. Website by: Black Wolf sp. z o. o.