The frontline of scientific communication.
According to our medical writing specialists, an effective medical communication is a key factor to guarantee the regulatory approval of a product and to increase the scientific knowledge among healthcare professionals.
The accumulated experience of the Medical Writing team over the different stages of product clinical development allows a deep understanding and knowledge of the regulatory environment and inherent methodological challenges, translating into robust strategic communication plans and development of accurate and compliant research documents.
Every medical writer assigned to a project collaborates directly with clients and clinical experts to provide clear, well-structured and consistent documents, taking into account the quality standards, concerned clinical background, targeted audience and regulatory framework.
All documents developed by our medical writing services are compliant with the applicable national and international regulatory requirements (including FDA and EMA) and universally accepted guidelines (e.g., ICH-GCP, CONSORT and STROBE).
- Design or revision of clinical study synopsis (including the support in the definition of strategies for product clinical development)
- Design or revision of clinical study protocols
- Writing of scientific articles (original paper, reviews, other)
- Articles submission to journals including support in the selection of the appropriate Journal and peer review process
- Writing or revision of abstracts/summaries and posters to congresses or other events
- Planning, conduction and reporting of expert Panels/advisory boards
- Development of clinical study reports (CSR) according to the applicable ICH guidelines and regulatory requirements
- Variables definition for data collection tools (case report forms, patient reported outcomes, surveys)
- Writing of informed consent forms and other documentation addressed to the patient
- Replies to opinions issued by health authorities and ethics committees
- Literature search for systematic reviewer as a background for potential studies, as well as in the scope of health technology assessment (HTA) studies.
Our 18-year old team:
Eurotrials has a team of Medical Writers leaded by Luís Veloso, Medical Writer Manager, who is at Eurotrials for 18 years. Every medical writer assigned to a project collaborates directly with clients and clinical experts to provide clear, well-structured and consistent documents, taking into account the quality standards, concerned clinical background, targeted audience and regulatory framework.