Medical Writing
Scientific regulatory documents - required for the conduct of clinical trials, for interactions with regulatory bodies or ethical committees, for regulatory submissions and other circumstances - need to be prepared with the best available internal and external knowledge of the medicinal product (and product class), with a clear understanding of the applicable requirements (external and internal quality standards; SOPs), with expertise in scientific approach, and subject to the requirements and expectations of the target audience.
toclinco has created numerous scientific and scientific-regulatory documents in consultation with internal and external stakeholders. These documents are straight to the point, logical, and the different document parts relate well to each other. Such documents are usually well received by the appropriate bodies.
The following types of documentation can be prepared, reviewed and delivered:
- Clinical development plans (CDPs; refer to Clinical Development)
- Briefing packages for regulators
- Clinical trial protocols , case report form, patient information, and clinical trial reports)
- Investigator's Brochures
- Investigational Medicinal Product Dossiers (IMPD; EMA or IND; FDA)
- Biological and clinical evaluations (of medicinal devices)
- Advanced-therapy medicinal products (ATMP) documents
- Orphan medicinal product designations - scientific part
- Scientific manuscripts (according to journals requirements)
- Benefit-risk assessments of out of specification issues
Additional documentation not specified above can be prepared and customized by toclinco to meet your precise requirements.