Medical Affairs, Medical Writing & Publishing

Excelya>Capabilities>Medical Affairs, Medical Writing & Publishing
SAFETY, ACCURACY, INTEGRITY

Medical Affairs: Expert staff, inside and outside

Our Medical Affairs team works closely with local and international Key Opinion Leaders and with our pivotal operational departments, such as Clinical Operations for both Late Phase studies and Early Phase interventional trials, Regulatory Affairs, Data Management and Pharmacovigilance to deliver accurate and effective documents that meet the highest standards. Our highly flexible and customer-centric approach ensures constant communication with our clients to make sure your trial is done right.

Quality Control and Peer Review

Our objective: zero defects

Our tripartite methodology for quality control leverages our peer review process:

  • Experienced staff: Our staff leverages an average of 10+ years of experience to avoid common pitfalls.
  • SOPs & Document Library: We use a library of templates and checklist for key documents as well as our comprehensive SOPs.
  • Senior Review: Documents are double- and triple-checked through our senior peers to ensure compliance with current guidelines and to eliminate individual errors.
Excelya biotech consulting

Medical Writing: Putting your findings into words

Medical Writing and Publishing is a clinical research tool to help get your product to-market, faster. Effective communication is paramount in order to garner regulatory success.

The aim of an effective Medical Writing and Publishing team is to successfully illustrate the outcome of your trial via your documentation, interpreting the complexity of your datasets into accurate and actionable conclusions, then communicating those outcomes to regulators and medical journals.

Located in France and Greece, our team of PhD and Master’s level writers have contributed to over 100 peer-reviewed papers in high impact journals.

Fully optimize your study documents:

excelya FSP

Publishing

Publishing clinical trials data is an essential way for the medical community to boost innovation, avoid the duplication of clinical trial research, to foster confidence from the general public and to encourage development of new medicines. 

Our team work closely with our data managers and statisticians to develop documentation that is accurate, insightful and of the highest possible quality standards.

Medical Writing

Skillful medical writing marries proficient writing skills with a wealth of scientific knowledge. It allows complicated and technical information to be clearly communicated in a way that is easy to understand, by regulators and medical professionals alike.

The experienced Excelya tea can help you take care of:

  • Production and curation of regulatory documents
  • Manuscripts for medical journals
  • Abstracts
  • Product development documents
  • Protocol writing
  • Clinical study reporting
  • Posters
  • Brochures
  • More

Why Excelya?

DEDICATED, FULL-TIME 40 MEMBER TEAM

  • 40+ Medical Writers ready for your project
  • Full language proficiency

10 YEARS OF EXPERIENCE ON AVERAGE

  • A high level of task-related expertise
  • Up to 25 years of experience

EXCEPTIONALLY QUALIFIED TEAM MEMBERS

  • Our Medical Writers have at least a Master/PhD level education

HIGHLY KNOWLEDGEABLE STAFF

  • Experience in clinical studies across therapeutic areas and phases
Excelya's scope of action

What we deliver

Excelya’s 30+ Medical Writers average over 10 years of experience to make sure your documents meet the highest quality standards in record time.

We leverage that experience to produce documents at every stage of the clinical research protocol lifecycle, from development and submission to publication.

Our Medical Writers can help prepare a wide range of clinical regulatory documents across the research lifecycle, from study initiation to publication.

Study development and submission:

  • Literature reviews
  • Study synopsis, protocols and protocol amendments
  • Investigator brochures
  • Case Report Forms
  • Informed consent forms (ICFs)
  • Pediatric Assent Forms
  • Educational material for patients, healthcare professionals and pharmaceutical personnel

Study documents:

  • Clinical Study Reports, including CSR synopses for public disclosure
  • Toxicology and Permitted Daily Exposure (PDE) report
  • Clinical Evaluation (CER) and Trend Report for medical devices
  • Temporary Use Authorization (ATU) reports
  • Registration of results in Clinical Trials database
  • EMA Policy 70 redactions
  • Clinical and non-clinical sections of the Common Technical Document (CTD), including overviews for EU and US Regulatory Authorities

Safety documents:

  • Patient safety narratives
  • Development Safety Update Reports (DSURs)
  • Periodic safety update reports (PSURs)

Publication documents:

  • Conference materials: abstracts, posters, slide set presentations
  • Papers for submission in peer-reviewed journals, including systematic reviews
  • Medical marketing reviews and reports
  • Product website content for scientific audience and patients

Documents are written according to ICH recommendations and reporting guidelines for health research.

Excelya full service

Medical Monitoring

  • Medical review/advisory on study aspects and conduct
  • Medical assessment of Adverse Event reports for Pharmacovigilance
  • Medical review of Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR)
  • Medical input to the development and review of Risk Management Plan (RMP) and Signal Management
  • Benefit-risk assessment of medicinal products and devices

Feasibility

  • Protocol review and guidance
  • Contact with key opinion leaders requiring study specifications
  • Provision of epidemiological and scientific data
  • Feasibility questionnaire/survey development and review

Training

  • Medical Advisor course
  • Study design and conduct
  • Study document overview

Medical Support

  • Client-tailored advisory, review, and design of scientific documents, queries, and activities
  • Literature review
  • Functional Service Provision of Medical personnel

Market research and strategic planning

  • Therapeutic area questionnaires
  • Content of discussion of Focus Groups & Advisory Boards
  • Collaboration with Sponsor’s Medical and Market Development departments
  • Medical web/mobile application design

The role of Medical Writing and Publishing within a Clinical Trial

 

Medical writing is a technical form of factual writing for the nice of clinical research. A medical writer will be involved in a study at many different phases, from the protocol and study designs right up to the interpretation and communication of results in a regulatory document or medical journal. They are writers at their core, but their focus is on accuracy, medical and drug development knowledge, as well as excellent project management skills.

Accuracy is an essential part of the medical writer’s toolkit. Getting documents right the first time can prevent costly amendments later on, particularly when it comes to protocol writing. Clarity is another skill that a medical writer must master, as using specificities and clear instructions will also help to avoid deviations from the intended protocol.

Reviewing and editing is an essential part of medical writing and publishing capabilities, including interpreting statistical analyses and information and translating that into an appropriate document, reviewing existing documents for accuracy, and reviewing the tone of voice of the document: for example, is the document intended for a regulatory submission, for patient education, or is it meant to inform a medical professional? This will need to be reflected in the format and the language used in the document. Word count, readability, and other formatting requirements must also be respected in any medical writing work. A deep understanding for the reviewing and editing process, as well as audience awareness – such as regulatory authority guideline knowledge – is essential.

An excellent medical writing team can help boost the commercial success of your drug molecule or medical device. For example, studies suggest that journal submissions written by a medical writer are more likely to be published. As such, the power of investing in a skilled and knowledgeable medical writing resource should not be overestimated.