Medical Writing

Regardless of your product study phase, our highly skilled medical writers can save you time and costs by clearly and accurately writing the medical documents your development program requires. We will provide you with thoughtful, cohesive medical documents that will stand up to regulatory and industry scrutiny.

Below are examples of the various medical documents we routinely write:

• Trial synopses, protocols and amendments
• Patient information sheets & informed consent forms
• Case report form (CRF) design
• Patient questionnaires & diaries
• Investigator Brochures
• Standard operating procedures (SOPs )
• Summary of clinical safety/ISS
• Integrated summary of efficacy (ISE) reports
• Non-clinical pharmacology and toxicology
• Benefit-risk analyses
• Integrated clinical trial reports (ICH E3) / interim reports
• Common Technical Documents (eCTDs)
• Patient narratives (for safety reporting)
• Periodic safety update reports (PSURs)
• Periodic adverse drug experience reports
• SAE narratives
• Regulatory reports
• Responses to deficiency letters
• Workshop presentations, abstracts, and posters
• Newsletters, advertisements for clinical studies
• Systemic literature search
• Publications for medical journals
• Review & editing of manuscripts in terms of language/grammar, scientific content, journal instructions, revision towards the view of journal editors and suggestions of reviewers