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Wordsmith Medical Writing is committed to providing high quality support and expertise to those who need a helping hand during the drug development process.
Medical Writing
Quality Control and Technical Editing
Formatting
Publishing
Consulting
Medical Writing
Preparation of clinical regulatory documents at the study level, across a development program, and for submissions (eCTD modules); examples include:
Protocols and amendments
Clinical study reports
Patient safety narratives
Investigator's Brochures and updates
Development Safety Update Reports
Module 2 summaries
Regulatory health authority or ethics committee responses and communications
Management of the document development process from start to finish
Submission planning and oversight
Quality Control and Technical Editing
Full and partial review of both clinical and non-clinical regulatory documents
Components can include checks for the following:
Source verification for text and data
Inter- and intra-document consistency
Editorial review and style guide compliance
Alignment with templates
Abbreviations
References
Formatting
Application of formatting templates and styles
Alignment with specified formatting standards
Visual and technical inspection of content and attributes
Preparing for appropriate conversion to PDF
Publishing
Document-level publishing of clinical and non-clinical regulatory documents
Alignment with eCTD-compliant standards
Ensuring appropriate conversion to PDF
Submission-readiness quality control review
Consulting
Recommendations for and implementation of structures, standards, and processes
Training and instructional resources
Creation and/or maintenance of the following:
Style guides and conventions documents
Templates
Standard operating procedures
Best practices, work instructions, and job aids
Abbreviations
References
Other projects as requested