Medical Writing

Excellent Medical Writing is essential for the presentation of clinical data as well as the communication of research results to different target audiences. This makes Medical Writing an important part of clinical research and this is why we take it seriously. Scientific and medical communication material should be clear, concise, scientifically accurate and fully compliant with international regulations, guidelines and industrial best practice – and this is what we stand for!

Our Medical Writers are highly qualified scientists (PhD or approbated pharmacists) and regularly extend their knowledge via training at conferences held by the European Medical Writers Association (EMWA) and the EMWA Professional Development Programme. They have excellent writing and communication skills and are experienced in preparing documents for any therapeutic indication.

Our Medical Writers closely work with our colleagues in the clinical pharmacology unit, project management, biostatistics and clinical data management as well as our scientific directors. All documents undergo thorough scientific, clinical and regulatory reviews as well as editorial quality control.

We timely deliver accurate and cost-effective documents with highest ethical and scientific standards and offer a wide range of Medical Writing services from individual documents to larger Medical Writing projects tailored to our customers’ needs. Our experience includes:

Clinical and Regulatory Writing

• ICH-GCP-compliant Clinical Study Reports (CSRs); Phases I to IV and non-interventional studies, including CSR Synopses for public disclosure
• Study Protocols and statistical planning documents (SAP, DMP)
• Investigator’s Brochures (IBs)
• Patient Safety Narratives
• Patient information including Informed Consent and Patient Brochures
• Pharmacovigilance documents such as Periodic Safety Update Reports (PSURs)
• Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Clinical Research Organisation (CRO)
• Scientific Advice documents
• Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
• Expert Statements
• IMPD including quality dossiers

Our services are fully compliant with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) regulations.

Scientific Communication

• Full support for manuscripts (primary and secondary) – from journal selection to publication
• Conference materials (abstracts, posters and slide presentations)
• Educational materials for different target audiences including, but not limited to website content, brochures, print inserts
• Technical illustrations for brochures, leaflets and package inserts

Our services are fully compliant with Good Publication Practice guidelines (GPP3) and the recommendations of the International Committee of Medical Journal Editors (ICMJE).