Medical writing and publications management | Modis

Medical writing of regulatory and clinical documents and publication management

Modis is one of the leading providers of scientific and medical writing services in Belgium. Our medical writers are experienced in writing clinical documents (Phase I through Phase IV), scientific publications and regulatory documents. In addition, Modis has an international team of publication experts who coordinate all the activities surrounding the delivery of a publication plan. Our medical writers and publication experts apply international publication guidelines to ensure that publications are delivered according to best practices and the very highest standards.

Flexibele en deskundige ondersteuning van a tot z

Our USP's

  • We collaborate closely with your stakeholders to help you develop comprehensive documents.
  • We ensure on-time, on-budget delivery by coordinating the writing, review and approval processes of your applications – according to the highest standards of scientific integrity and regulatory requirements.
  • Complex publication plans are our specialty – we help implement a database system that simplifies publication milestones and optimizes interactions between multiple IT applications.
  • Our publication planning database system experts help your team build and maintain a portfolio of published articles to support your promotional and scientific efforts.

Service overview

  • Regulatory and clinical writing
    We help you write a wide range of clinical and regulatory documents, including study protocols, ICH GCP-compliant clinical study reports (CSRs), clinical summaries, investigator brochures, patient safety narratives, patient communications and more.
  • Publications
    Our experts assist with the production of scientific publications, conference materials, including abstracts, poster presentations, slide decks and manuscripts. Our publication managers ensure on-time and on-budget publication plans by coordinating the writing, review and approval processes of your publications – according to the highest standards of scientific integrity.
  • Public disclosure and communication services
    We handle your manual data entry tasks for public disclosure via the NIH website, EudraCT and your own clinical trial registry website. We also offer specific services such as organizing advisory boards, developing your reimbursement dossiers and preparing and submitting program requests.

Onze Experts

Our large team of medical writers and publication managers have worked in academia, industry and clinical research. Our international team offers writing services in French, Dutch, German, Spanish and more, and develops documents according to recognized standards such as ICH, EMWA, ICMJE, CONSORT, STROBE, ISPOR and GPP.

  • Publication, clinical and regulatory writers
  • Publication managers
  • Publication assistants
  • Disclosure managers
  • Disclosure assistants

Doelmarkten

From biotech to academia, Modis can offer you the specialisms that your business case requires.

  • Biotechnology
  • Pharma
  • Medical devices
  • Research institutes
  • Universities

Supporting IT Tools

Every project requires different types of collaboration and knowledge-sharing activities. We’re familiar with all the standard tools available – and many extras. Even more, we support the development of audio slides and videos for publication.

Back

Modis provides pharma leader with an innovative publication platform 

Client core business

Our client is a global pharmaceutical company that researches, develops and manufactures vaccines.

How Modis added value

This pharma firm conducts numerous clinical trials and was looking for a solution enabling the easy distribution of publications. As the project would require strong management support and be subject to complex ethical and regulatory requirements, the client requested the expertise of Modis medical writing and coordination professionals.

We composed a team of publication managers, medical writers and support staff. They delivered an end-to-end solution, from developing a tailor-made publication platform and creating content to communication and quality control. As a result, the 200 documents created annually are published on time according to the strictest quality and ethics requirements. 

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