Clinical Writing

WebbWrites clinical writing team is composed of highly skilled professionals committed to producing quality documents, including:

• Clinical study reports (Phase 1, 2, 3, and 4)
• Common Technical Document clinical overviews and summaries for Modules 2.5 and 2.7
• Integrated Summary of Effectiveness and Integrated Summary of Safety
• Clinical protocols
• Subject narratives
• Safety updates
• Briefing Books for regulatory interactions
• Investigational New Drug applications
• Investigator Brochures and updates
• Manuscripts
• Quality assurance / quality control of documents

All documents undergo several internal quality-control checks prior to delivery, which consist of 100% verification of all numbers quoted in the text at the time of issuing the first draft and again prior to finalization, as well as review by senior-level personnel for overall interpretation of the data. Clinical study reports can typically be prepared within 2-4 weeks and summary documents within 4-6 weeks, depending on complexity.

Once final, documents and associated appendices can be published in Adobe format, including bookmarking and hyperlinking.