Medical Writing
Expect clarity, compliance, and quality. Expect more.
TFS Medical Writing at a glance
We believe that the quality of documentation can influence the flow of a clinical study. That’s why we are dedicated to providing you with the documents you need to support your drug’s development journey with confidence. Our medical writers provide you with documents written with clarity in the languages you require and compliant with all ICH guidelines and regulatory requirements. They are experienced in writing for key therapeutic areas covering all phases of clinical development, including real-world evidence.
Cooperation, continuity, clarity
The global medical writing team is made up of professionals, including MDs and others with advanced training in health science, such as biomedics and biologists. As quality EMA- and FDA-compliant documentation writing is imperative to us, they were chosen because of their strong research background, excellent language skills, and knowledge of biostatistics. Many are members of the European Medical Writers Association (EMWA).
Our writers tend to work with us for years, which enables us to provide continuity and experience to our customers. Half of our medical writers have more than ten years of experience.
For us, experience means efficiency, and clinical trials are incredibly time-sensitive. Usually, you can expect the first drafts of protocol and CSR in four to five weeks. Further versions can be delivered within five and ten working days after receiving your comments.
Throughout the trial, TFS medical writers cooperate closely with other teams involved in the study so you can expect clarity, accuracy, and compliance in every document.
Medical writing for clinical trials
Our expert team of writers supports you in every step of the study from beginning to end. They are skilled in writing protocols and CSRs with a complete scope of study types, depending on the main goal of your study. Following is a list of the types of documents our medical writers produce for customers:
Regulatory Writing
- Clinical development plans
- Clinical study protocols
- Clinical study reports
- Posting of clinical trial results (EudraCT and Clinicaltrials.gov)
- Medical review data
- Investigator brochures
- CTD clinical overview
- Investigational Medicinal Product (IMP) Dossiers
- Investigational New Drug (IND) Dossiers
- Transparency and Disclosure of Data in Clinical Trials (EMA policy 0070)
- Clinical evaluation reports
- Aggregated safety reports
- Integrated summaries of safety/efficacy (ISS/ISE)
- Lay summaries
- Briefing documents
Medical Communications
TFS medical writers can help you translate complex data and concepts into messages that people can understand.
Preparation of complete communication plans for product- or study programs
Abstracts, posters, and oral presentations for conferences or other meetings
Advisory board reports and scientific congress reports
Preparation of review articles, including literature reviews, systematic reviews, and meta-analyses
Scientific manuscripts of clinical trials, non-interventional studies, case reports, etc.
Educational and marketing materials (slide kits, infographics, newsletters, graphical abstracts, blogs, and web content)
Assistance with publication submission (article, abstract, poster, etc.), pre-submission scientific editing, English language review, statistical review, and revision of manuscript in response to peer review comments
Real World Evidence (non-interventional studies) support
Our medical writers have a wide range of experience in non-interventional studies, including:
Epidemiological studies
Post-authorization safety studies (PASS)
Post-authorization effectiveness studies (PAES)
Health outcomes research studies
Health economic studies
Choose TFS Medical Writing to support the success of your study
We take pride in our documents being accepted by our clients for submission-ready issues or health authority validation issues.
- 10+ committed global medical writers with a >90% retention rate
- 98% approval of study protocols by ethics committees and health authorities
- 99% acceptance rate of abstracts, posters, and oral communications
- 95% of manuscripts published in peer-reviewed journals
- >100 congress presentations delivered in 2022
- >1200 documents completed in the past five years in >15 therapeutic areas
