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We provide medical writing and medical monitoring services throughout the new drug development cycle, including target investigation, development strategy, simultaneous IND submissions to FDA/CDE, protocol writing, medical monitoring, CSR, and NDA document preparation, etc.
Writing/review of IND medical documents
Writing/review of clinical trial protocol
Review of ICF, recruitment advertisements, and eCRF
Writing of CSR and NDA documents
Medical Monitoring Plan / Medical Monitoring Report
Review of subject enrollment
Review of AEs and SAEs
Assessment of drug AE relationship
Review of protocol deviations
Project-related medical support
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