The key to professional success for researchers is the precise presentation of scientific ideas and results, which helps maximize the accuracy and impact of written documents. Although medical and clinical research professionals are experienced in the field of research, expertise in the field of regulatory science writing and publication of scientific papers is still a gap, and Exom has converted this into an asset by a scientific medical writing group.
Medical Writers at Exom Group are professionally qualified in combining medicine, science, writing skills and simplicity to deliver concise documents for all stages of a clinical trial, supporting regulatory submission, project management, up to the final report.
We work in accordance with FDA, EMA and ICH guidelines and regulations to deliver a wide range of clear, concise clinical documents and publications on time and in harmony with your company’s style and format.
Our Medical Writing Services
- Trial synopses, protocols and amendments
- Patient information sheets & informed consent forms
- Case report form (CRF) design
- Patient questionnaires & diaries
- Standard operating procedures (SOPs)
- Integrated Summary of Safety (ISS) reports
- Non-clinical pharmacology and toxicology reports
- Integrated clinical trial reports (ICH E3) / interim reports
- Case Narratives
- Abstracts & Manuscripts
- Newsletters, advertisements for clinical studies
- Documentation for congress exhibits
- Investigator’s Brochure integrations (IBs)
- Data safety monitoring board (DSMB) manuals
- Written and tabular summaries
- Benefit/risk assessment reports
- Medical and scientific literature reviews
- Investigational Medicinal Product Dossiers (IMPDs)
- Investigational New Drug documents (INDs)
- Pediatric Investigation Plans (PIPs)
- Trial synopses, protocols and amendments
- Patient information sheets & informed consent forms
- Case report form (CRF) design
- Patient questionnaires & diaries
- Standard operating procedures (SOPs)
- Integrated Summary of Safety (ISS) reports
- Non-clinical pharmacology and toxicology reports
- Integrated clinical trial reports (ICH E3) / interim reports
- Case Narratives
- Abstracts & Manuscripts
- Newsletters, advertisements for clinical studies
- Documentation for congress exhibits
- Investigator’s Brochure integrations (IBs)
- Data safety monitoring board (DSMB) manuals
- Written and tabular summaries
- Benefit/risk assessment reports
- Medical and scientific literature reviews
- Investigational Medicinal Product Dossiers (IMPDs)
- Investigational New Drug documents (INDs)
- Paediatric Investigation Plans (PIPs)