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Our Services

Medical Writing
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  • Clinical protocols and protocol amendments

  • Full and synoptic integrated clinical study reports (CSRs)

    • BA/BE

    • Drug-drug interaction

    • First in human -- SAD/MAD

    • Food effect

    • Renal or hepatic impairment

    • Immunogenicity

    • Pharmacokinetics and pharmacodynamics

    • Thorough QTc (TQT)

  • CSR errata and addendum documents

  • Safety narratives and safety summaries

  • Investigator brochures

  • Informed consent forms (ICFs)

  • Educational articles and patient brochures

  • Journal manuscripts

  • PowerPoint slide decks for topline data review and interpretation meetings

Electronic Publishing
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  • Draft and final CSR publishing, including ICH E3 appendices with full submission-compliant hyperlinking and bookmarking per eCTD specifications

  • Document level publishing, such as ICFs, electronic case report forms (eCRFs), statistical analysis plans, and tables, listings, and figures

  • Electronic appendices compilation

Quality Review
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  • Customized Quality Review

    • AMA Manual of Style 10th Edition

    • Client style guide

    • Specific source documents

    • Spelling, grammar, punctuation

    • Within-document consistency

    • Fonts, styles, headers/footers

  • Medical editing by a board-certified editor in the life sciences (BELS certification)

  • Compliance of regulatory submissions (NDAs, INDs) with regulatory guidelines

  • Integrity of reported data based on comparison with source tables, listings, and figures

  • Consistency and accuracy of text based on related protocols and references

  • Draft and final appendices deliverables

  • Basic editorial issues

Consulting

Interested in starting a medical writing department or developing the one you already have? Let us help!

We provide consultation services in the following areas:

  • Writing standard operating procedures (SOPs) and working practice documents (WPDs)

  • Creating templates, guidelines, and instructions for writing documents

  • Developing processes and timelines for completion of documents

  • Helping staff improve organization and time management skills to increase efficiency and productivity

Training

Do you need training or continuing education for your medical writing staff?

We provide on-site or on-line training in the following areas:

  • Writing individual sections of the CSR based on ICH E3 guidelines (Structure and Content of Clinical Study Reports)

  • Interpreting safety data

  • Introduction to TQT studies for Phase 1 medical writers

  • Introduction to study design

  • Basic pharmacokinetics for medical writers

  • Protocol design and development

  • Basic biostatistics

  • Proficient use of Microsoft Word

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