The Medical Writing and Document Management group currently consists of 14 people:
- 9 Medical writers (all native English speakers with fluent German)
- 3 Specialists in document management and publishing
- Up to 28 years of experience in the field
- Background in the sciences, languages or in pharmacy
- 2 Editorial and administrative assistants
- Various academic titles, including 7 PhDs and 2 MSc's
- 2 Editors in the Life Sciences
Knowledge and experience of therapeutic areas:
- Cardiovascular diseases (hypertension, congestive heart failure, acute coronary syndrome)
- Cardiac interventions (PCI) and surgery (CABG)
- Coagulation disorders (plasma products)
- Metabolism (diabetes, GI ulcers)
- Neuroscience (Alzheimer's disease, schizophrenia, epilepsy, depression, anxiety, Parkinson's disease)
- Bone disease (rheumatoid arthritis, osteoporosis)
- Infectious diseases
- Endocrine disorders
- Dermatology (dermatitis, onchyomycosis)
- Pain management
- Ophthalmology
- Oncology (colorectal, prostate, head and neck, lung cancer)
- Nutrition (parenteral)
- Respiratory system (antihistamines)
- Medical imaging
- Clinical pharmacology and pharmacokinetics
- Health economics
- Quality of Life
- Drug-device combinations
- Investigator's brochures
- Clinical study protocols for phases I - III
- Clinical study reports for phases I - III, including population PK and health economics
- Clinical summary documents for European, US and CTD dossiers
- Clinical expert reports
- Responses to authorities' questions
- Clinical publication manuscripts and conference posters
- Standard operating procedures
- Standards manuals and templates
Production of published and fully cross-referenced preclinical and clinical reports and registration dossiers.
Expertise in latest high-speed scanning and image enhancement technology (Ascent Capture®, Imaging for Windows®, ISIFile™) and document management and publishing software applications
(Documentum® and CoreDossier™) for the production of major electronic dossiers and variations.
Streamlined business process:
Full integration of the publishing specialists and document managers into the project team - ensuring seamless cooperation with the medical writers, biostatisticians, IT specialists and regulatory
affairs specialists.
Entirely electronic compilation of documentation:
Documents can be made available both electronically and as paper, with GCP-compliant physical archiving.
- Management and development of the medical writing business, contacts with freelancers, CROs and agencies
- Input into clinical development and project plans on medical writing issues
- Resource management of medical writers
- Co-ordination and management of medical writing activities on international project teams
- Interpretation of regulatory guidance and structuring of clinical submissions
Development and maintenance of internal standards and templates for:
- Clinical development plans
- Clinical study protocols
- Clinical study reports
- Investigator's brochures
- Tables for clinical data
- Clinical summary documentation
Active involvement on ICH E3 "Structure and Content of Clinical Study Reports", ICH M4 "Common Technical Document", and international guidelines for publishing clinical trials in medical
journals.
Internal and external training modules written and presented on:
- Investigator's brochures
- Clinical study protocols
- Clinical study reports
- Clinical summaries and expert reports
- Table and graph design
- Statistics for medical writers
- Clinical publications
- Standardization and templates
- ICH E3 and M4
- Well-integrated, efficient group with many years of working together
- Adequate size to ensure smooth workflow during peak and trough times
- Complementary skills and knowledge to provide the full range of writing and consultant services
- Broad experience of different pharmaceutical products and therapeutic areas
- Broad experience of working in international and cross-functional teams
- Existing international contacts and reputation
