Medical Writing
Due to the complex regulatory framework, medical writing has become an indispensable service in the pharmaceutical development process. ICRC-Weyer offers writing services for a wide range of documents that meet the high demands of the regulatory processes involved in the development of drugs, medical devices or nutritional products.
It is our ambition to provide our clients with documentation that will help them realise their regulatory and marketing goals. We achieve this by transforming complex clinical data into concise and unambiguous documents, which effectively communicate the clinical relevance.
Medical writing at ICRC-Weyer takes a synergistic approach: Our medical writing personnel has a strong scientific background and cooperates closely with in-house specialists from the biostatistical and data management department as well as with our associated medical experts from various therapeutic areas. Therefore, we can offer a fully-integrated medical writing service in combination with qualified scientific consulting with respect to data presentation and interpretation. We offer our writing services either as part of the management of a whole clinical development program (phase I-IV) or as individual writing projects.
ICRC-Weyer has the experience to support you in planning, coordinating and structuring your clinical data. Our writing experts are fluent in medical and clinical trial terminology. They combine professional writing skills with a thorough understanding of ICH, EMA, MEDDEV, EFSA and FDA guidelines and of regulatory/publishing processes.
Our services:
- Clinical study protocol & reports
- Patient information & informed consent
- Investigator’s brochures
- Common technical documents (CTD), other formats
- Technical documents for medical devices
- Health claim applications
- Scientific communication materials (marketing and training materials)
