Services
promed writing offers professional medical and scientific writing services to:
- pharmaceutical and biotech companies
- contract research organizations
- medical communication agencies
- multimedia and graphic design companies
- individual research scientists
- research institutes
- healthcare professionals
- healthcare organizations
Services offered by promed writing include writing, editing and proofreading in various areas:
Regulatory documentation
crisp and clear messages
- Investigator brochures (IBs)
- clinical study protocols
- clinical study reports (CSRs)
- clinical trial applications (CTAs)
- paediatric investigation plans (PIPs)
- periodic safety update reports (PSURs)
- CMC/pharmacological/toxicological documentation
- clinical summaries & overviews in the CTD format
Medical and scientific communications
- abstracts
- posters (incl. graphic design and layout)
- manuscripts for peer-reviewed journals
- PowerPoint slide presentations
- product monographs
- literature reviews
Clinical trial disclosure activities
- summary information from clinical study protocols (for EU CTR and ClinicalTrials.gov)
- summary results from clinical studies (for EudraCT, EU CTR and ClinicalTrials.gov)
- summaries of study results in lay language (Return of Results Summaries; Summaries of Results in Lay Language)
- “clinical reports” redacted for personal information and commercially confidential information (CCI)
Documentation for health technology assessment (HTA)
- benefit dossiers for HTA according to § 35a SGB V (AMNOG)
Document quality control (QC)
- verification of numerical data against source data, adherence to templates, and consistency of data and statements using QC checklists
- for documents at the
- trial level, e.g.:
- clinical study protocols
- clinical study reports (CSRs)
- lay summaries
- project level, e.g.:
- Investigator brochures (IBs)
- summary/submission documents
- trial level, e.g.:
Moreover, promed writing prepares translations from German to English of any scientific or medical texts.
Get in touch with promed writing to discuss confidentially how you can obtain quality documentation in a timely and cost-effective manner.
promed writing also presents seminars and hands-on workshops on medical and scientific writing, customized to your individual needs.
Get in touch with promed writing to find out how you can enhance your writing skills.