Medical Writing

Activities are performed by our dedicated Medical Writing Unit, in full compliance with ICH guidelines and CROss Alliance SOPs. Our team has an extensive and documented experience not only in medical writing but also in regulatory activities and requirements, including all aspects related to clinical trials design and management.

They are active members of the European Medical Writers Association (EMWA) and are enrolled in the EMWA Professional Development Programme at both fundamental and advanced level.

CROss Alliance Medical Writing Unit designs and maintains templates for CSP and CSR, assuring inside company standardisation and quality of the documents. They provide project management of writing-only projects.
Activities are carried out in close collaboration with Project Leaders, Investigator(s), Biometrics and PK/PD unit(s) and the Sponsor.

Summary of medical writing activities:

Clinical Study Protocols, (CSP) preparation or revision, in compliance with ICH GCP Topic E6(R1).

Clinical Study Reports, (CSR) preparation or revision, in accordance with ICH E3 Note for Guidance on Structure and Content of Clinical Study Reports and Final integrated CSR, including all appendices. CSR are released as eCTD-ready or as fully eCTD-compliant documents, upon Sponsor’s request, in accordance with the ICH M2 Expert Group eCTD Specification Document in both electronic and paper copy.

Investigator’s brochures, (IB) preparation or revision, ICH E6(R1)-compliant.

Investigational Medicinal Products Dossier, (IMPD) are usually revised upon specific Sponsor’s request; occasionally IMPD are entirely prepared, (CMC part is provided by Sponsor).

Other regulatory documents, or Medical Affairs departments support, as required, e.g.: Abstracts for conferences, Expert reports, replies to Regulatory Authorities in relation to Clinical Trial Applications (clinical part only), Paediatric Investigational Plan, (PIP) preparation or revision, detailed Study Synopsis for request Competent Authorities advice.

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