Astranix Medical Writing Services
★ Medical writing is a creation of scientific documents by specialised writers as it requires specialised skills to present scientific information.
★ End-to-end support for medical writing, editing, full and comprehensive review of regulatory and scientific documents, and responses to regulatory and health authorities.
★ Systematic literature reviews for particular therapeutic and product areas.
★ Organizing and incorporating information to documents, such as clinical and scientific results, evaluation reports, literature content references, and graphics, tables, and data listings.
★ Reviewing and providing input on medical and scientific data, including gap analyses.
★ Providing insight into clinical research, device/drug development processes regulatory requirements, good clinical, and data management practices.
★ Quality check for all documents to comply with ICH requirements.
★ Deliver in time with utmost focus on high standards of quality.
We provide end-to-end support for the following types of documentation
★ Investigator Brochures (IBs)
★ Case Report Forms (CRFs)
★ Clinical Study Reports (Phase-I to IV)
★ Informed Consent forms (ICF)
★ Clinical and non-clinical summaries
★ Subject narratives/summaries