Clinical Writing

WebbWrites is committed to producing quality documents, including:

  • Clinical study reports (Phase 1, 2, 3, and 4)
  • Common Technical Document: Clinical Overview and Summaries for Modules 2.5 and 2.7
  • Integrated Summaries of Effectiveness and Safety
  • Clinical protocols
  • Subject narratives
  • Development Safety Update Reports
  • Briefing Books for regulatory interactions
  • Investigational New Drug applications
  • Investigator’s Brochures and updates
  • Manuscripts
  • Quality assurance/quality control of documents

PROFESSIONALS COMMITTED TO PRODUCING QUALITY DOCUMENTS


Flexibility

Clinical study reports can typically be prepared within 2-4 weeks and summary documents within 4-6 weeks, depending on complexity. However, WebbWrites can accelerate document preparation using various methods, including finalization of non-data sections prior to data delivery, rolling receipt of data, rolling quality control of documents, use of draft data, real-time incorporation of comments during round-table reviews, and working on-site with the Sponsor.


Quality

All documents undergo several internal quality-control checks prior to delivery, which consist of 100% verification of all numbers quoted in the text, as well as review by senior-level personnel for overall interpretation of the data.



Process

WebbWrites can provide a bid once foundation materials, proposed timelines, and any company-specific templates are provided. Sponsors work with the same WebbWrites’ point person throughout the life of their submission, as we do not subcontract and our employees are 100% full-time staff.