Medical Affairs, Medical Writing & Publishing

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Get your medical writing right

Excelya’s dedicated team of expert medical affairs professionals and medical writers focus on accuracy to ensure high-quality deliverables.


Medical affairs and writing to help you excel

Every clinical project involves medical communication and medical writing, from study protocols to peer-reviewed publications and presentations, to clinical study reports. High-quality communication can put your project in front of the people you need to see it and unlock the commercial value of your research.

A medical writer is involved in a study at many different phases, from protocol to peer-reviewed manuscript. Medical affairs professionals focus on communicating clinical information with different audiences.

Excelya has the expert medical writers you can rely on to produce clear, accurate, and high-quality communications, protocols and clinical study reports.

Start telling your research story

Excelya’s experts put your research into words

Our team over 100 medical affairs professionals and medical writers work in 28 countries on three continents. Their extensive local knowledge and language proficiency means we can support your communication needs, whatever and wherever your trial is.

They aim to successfully illustrate your clinical trial through documentation that is accurate, insightful, and high-quality. This can involve turning your complex datasets into actionable conclusions and communicating them in a way that engages regulators, medical professionals, and patients.

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Why publish your trial data?

There are increasing calls to publish the findings of clinical trials, as this is an essential way to boost innovation, avoid the duplication of research, foster confidence from the general public, and encourage the development of new treatments. As well as increasing transparency, it enhances trial participation by empowering patients with knowledge about the available options.

Research suggests that medical writing professionals can play a role in improving the quality of published reports about clinical trials, by ensuring better use of language and supporting more complete reporting.

Our global team of medical writers have contributed to more than 100 peer-reviewed papers in high-impact journals around the world, and they can apply their experience to your manuscript.

What do you need to communicate?

Expert communicators to support your team

We know that mistakes can be costly, as they can lead to duplicated efforts and errors in implementation. That’s why we value accuracy and ensure our writers have a high level of expertise.

Our medical writers are PhD and Master’s-level experts with an average 10 years of experience.

Our expert medical affairs professionals and medical writers have experience working on clinical studies and investigations across therapeutic areas and phases. They are highly skilled in:

• Writing for different audiences, including regulatory agencies and patients
• Project management and stakeholder engagement
• Interpreting statistical analyses and information and translating it for different purposes
• Reviewing existing documents for language, accuracy, tone of voice and formatting

Strengthen your team’s communication capability

Flexible support that scales with your project

Study development and submission:
  • Study design and protocol synopses
  • Study protocols and protocol amendments
  • Investigator brochures
  • Lay summaries of study protocols and clinical study reports
  • Informed consent forms (ICFs)& Pediatric Assent Forms
  • Literature review
  • Educational material for patients, healthcare professionals and pharmaceutical personnel
    Study documents:
  • Clinical Study Reports
  • Clinical Evaluation (CER) for medical devices (including IVDs and software)
  • Temporary Use Authorization – Early Access reports
  • Clinical and non-clinical sections of the Common Technical Document (CTD) (for Europe, US, Japan)
  • Quality Check (QC) for language, content validity, and formatting
Medical Communications and Publishing:
  • Registration of results in Clinical Trials database
  • EMA EU CTR CTA regulatory submission redaction, EMA Policy 70/ Health Canada / US Final Rules de-identifications
  • Conference materials: abstracts, posters, slide set presentations
  • Manuscripts for submission in peer-reviewed journals, including systematic reviews
  • Product website content for scientific audience and patients
  • Electronic Document Submission (eDS)
excelya FSP
Medical Monitoring and Safety Physicians:
  • Medical review/advisory on study aspects and conduct
  • Medical review of patient data, coding, and safety information
  • 24-hour support of Medical Monitors to the study team and investigative sites
    Medical Support
  • Client-tailored advisory, review, and design of scientific documents, queries, and activities
  • Medical training (processes, regulations, therapeutic areas)
  • Medical web/mobile application design
Functional Service Provision of Medical Personnel:
  • FTE-based and deliverable-based FSP solutions
  • Medical Writers
  • Medical Science Liaisons
  • Medical Advisors
  • Medical Managers
  • Quality Check Specialists
  • Electronic Data Submission Experts
  • Redaction Specialists
  • Medical Monitors
  • Clinical Research Directors
  • Medical Data Officers

Our expert medical writers are ready to help you