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Clinical Medical Writing

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The GLOBAL Approach

We work with your team and subject matter experts to develop a data-driven messaging strategy for your program across all documents. This strategy ensures that document users, whether clinical decision makers or regulatory approvers, have quick access to the product information that is most relevant to their needs.

Our Services Include:

  • Content authoring

  • Technical editing and formatting

  • QC review

  • Document publishing

  • Project management

Clinical Documents

Protocols

  • Synopses

  • Full protocols

  • Amendments (global and region-specific)

 

Investigator Brochures

  • Full IBs

  • IB updates

 

Clinical Study Reports

  • Full

  • Abbreviated

  • Interim

  • Synoptic

Informed Consent Forms & Patient Information Leaflets

Patient Safety Narratives
 

Regulatory Documents

Investigational Applications

  • Investigator New Drug Applications & Clinical Trial Applications

  • Applicable Common Technical Document summary modules, including the following:

    • General Investigational Plan

    • Nonclinical overview (Module 2.4)

    • Nonclinical written summaries (Modules 2.6.1, 2.6.2, 2.6.4, & 2.6.6)

    • Nonclinical tabulated summaries (Modules 2.6.3, 2.6.5, & 2.6.7)

    • Nonclinical study reports (Module 4.2)

 

Briefing Books and Meeting Request Letters

 

Pediatric Investigation Plans & Pediatric Study Plans

 

Risk Management Plans

 

Marketing Applications

  • New Drug Applications, Biologics License Applications, & Abbreviated New Drug Applications

  • Applicable CTD summary modules, including the following:

    • Clinical Overview (Module 2.5)

    • Clinical summaries (Modules 2.7.1 through 2.7.6, including Integrated Summary of Safety & Integrated Summary of Efficacy modules)

    • Tabular listing of all clinical summaries (Module 5.2)

    • Clinical study reports (Module 5.3)

 

Other Health Authority Communications

  • Orphan Drug Designation requests

  • Breakthrough Therapy Designation request

 

Safety Management and Pharmacovigilance Documents

(aka, Aggregate Safety Reporting)

  • 120-Day Safety Update Reports

  • Development Safety Update Reports

  • Periodic Safety Update Reports

  • Periodic Benefit-Risk Evaluation Reports

  • Patient Safety Narratives

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