MEDICAL WRITING

Medical Writing services at CROM include

• Concept Sheet preparation for Abbreviated New Drug Applications (ANDA) submissions

• Protocol writing / Development

• Phase II to IV studies

• Phase I and Patient-based PK studies

• Proof of concept and early phase clinical trials

• Informed consent forms

• Diaries

• Clinical Study Report

• Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities

• Investigator Brochures

• Standard Operating Procedures (SOPs) covering of drug development including

• Design

• Conduct

• Reporting of clinical trials