Sage Services 


We offer authoring, editing, and quality review as an integrated service and also as individual services. We are comfortable authoring documents in common technical document (CTD) format for US, EU, and rest-of-world pharmaceutical markets. We work with our clients to ensure that all electronic documents are publishing ready. Specific document specialties include the following:

 

·        Components of clinical trial clearance applications

o     Study protocols

o     Investigator brochures

o     Clinical and nonclinical summaries

o     Annual reports

·        Full, abbreviated, and synoptic clinical study reports

·        Subject medical narratives

·        Clinical and nonclinical summary and overview components of product approval applications

·        Regulatory briefing packages and response documents

·        Product license renewals (EU)

·        Orphan drug applications

·        Pediatric investigation plans and waiver requests

·        Manuscripts, posters, and abstracts

 

We also offer training and education services, including the following:

 

·        Medical and technical writing and editing workshops

·        Good review practices seminars
 

Our consultation services include the following:

·       Standard operating procedure development

·       Writing style manual development and documentation