ODC’s multidisciplinary team with proven medical writing skills will ensure that content, accuracy and presentation of any document meet the highest quality standards. Our medical writers work in cooperation with our consultants in the fields of oncology, pharmacovigilance, medical devices, ethics, and GCP. Tasks involve all steps from drafting, reviewing, updating to full writing of regulatory documents, including:

• Investigational Medicinal Product Dossier (IMPD)
• Investigational New Drug (IND) file
• Investiagator Brochure (IB)
• Clinical study protocol and synopsis
• Study-, country- and site- specific master informed consent forms (ICFs)
• ICH E3 compliant clinical study report (CSR)
• PSURs
• DSURs
• Risk Management Plan