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.
Our tripartite methodology for quality control leverages our peer review process:
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.
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.
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:
DEDICATED, FULL-TIME TEAM
10 YEARS OF EXPERIENCE ON AVERAGE
EXCEPTIONALLY QUALIFIED TEAM MEMBERS
HIGHLY KNOWLEDGEABLE STAFF
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:
Study documents:
Safety documents:
Publication documents:
Documents are written according to ICH recommendations and reporting guidelines for health research.
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.
