Services
Medical Writing and Translations
We can write it for you
Our Medical Writing team is integrated into our global team of experienced data managers and statisticians, scientists, physicians, clinical pharmacologists and qualified personnel in pharmacovigilance, registration and regulatory affairs.
We can help in the preparation of:
- New drug applications
- Investigator brochures, a concise and user friendly brochure
- IMP dossiers, prepared together with our associate partner Verius Ltd
- Clinical study protocols and amendments prepared to ICH-GCP, or review and advice on your study protocol
- Subject information sheets and consent forms identifying the purposes, benefits and risks of the study and the subjects obligations
- Interim and abbreviated clinical study reports
- Final clinical study reports according to ICH E3 format
- Case narratives
- Annual safety reports meeting the demands of SAE/SUSAR reporting requirements
- Periodic safety update reports
- Package inserts, patient information leaflets written in lay terms
- Summary of product characteristics
- Clinical study presentations
- Product presentations for inclusion in marketing authorisation packages
- Scientific publications and marketing publications prepared in cooperation with sponsors and investigators
All medical writers are qualified in medicine or the life sciences and are members of the European Medical Writers Association. All documents are peer reviewed and undergo formal quality control before release.
Our Translation team consists of native speakers with many years experience in translating all documents necessary for the performance of clinical studies, such as:
- Submissions to ECs/IRBs and health authorities
- Correspondence
- Protocol synopses
- Protocols
- Subject information sheets
- Medical reports
- Abstracts
- Patient instructions
- All other study related documentation
We can work to our or your SOPs and templates and all services can be contracted independently, thereby providing you with the best possible service with high quality documents and rapid turnaround times.
Feel free to phone us
...straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0
Dr. Vera Yeomans,
Manager Medical Writing