We offer expert medical writing support to expedite your submissions and approvals. Our medical writers prepare, create and update your documents and publications quickly, cost-effectively, and in compliance with regulations.
We can support you in writing all documents required in the clinical research process of a medical device, IVD, pharmaceutical, biologic or combination product. Our medical writers utilize templates and forms to ensure completeness and regulatory compliance. We also write scientific manuscripts and conference presentations. With the target group in mind, we start by evaluating the best strategy to use based on the available data and purpose.
Examples of our medical writing services:
- Clinical study protocol/clinical study report
- Clinical investigation plan/clinical investigation report
- Clinical performance study protocol/clinical performance study report
- Patient information and informed consent
- Case Report Forms (CRFs)
- Investigator brochure
- Patient diaries and questionnaires
- Applications to competent authorities and ethics committees, including clinical study documentation
- Registration of clinical studies in public databases
- Interim/final reports
- Publications
- Safety documents
- Marketing materials
- Literature search
