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Clinical Trial Document Authorship

The GLOBAL CRO Approach

Preparation of high-quality documents is a critical step in the regulatory process of your project.  Protocols must translate clearly and efficiently your study goals, labeling requirements and ensure compliance with all applicable regulatory bodies.  Associated trial documents such as informed consent forms and investigator brochures must be completed accurately and expeditiously to maintain your trial timelines.  At the end (or at interim timepoints), your study data and results must be compiled into an accurate and detailed report, while maintaining both your timelines and any applicable regulatory requirements. 

Our medical writers have decades of collective experience in writing all types of documents, and will work with you and your project manager to achieve your project goals.

Our Services Include:

  • Clinical Study Protocols  

  • Clinical Study Reports 

  • Investigator’s Brochure (IB) 

  • Informed Consent Forms (ICF) 

  • Clinical Events Committee (CEC) Charter 

  • Data Monitoring Committee (DMC) Charter 

  • Common Technical Documents (CTDs) 

  • Study Plans (e.g. Monitoring Plan) 

  • Monitoring Visit Reports 

  • Safety Reports  

Why Choose GLOBAL CRO?

GLOBAL CRO has an experienced and professional team that can author clinical and non-clinical documents throughout the life cycle of your clinical trial. 


Our proficiency with clinical documentation and writing includes extensive knowledge in multiple therapeutic areas.  We offer a complete range of writing services that can be tailored to your clinical trial needs. 

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Let's Work Together

Email us today to discuss your project and learn more about our services.

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