Clinical Trial Protocol Writing & Strategy Support

GLOBAL delivers clear, compliant, and scientifically sound protocols that drive regulatory success and ensure operational clarity.

End-to-End Protocol Development for Clinical Trials
‍The clinical trial protocol is the foundation of your study. It must be scientifically robust, operationally feasible, and fully compliant with regulatory requirements. Whether for early-phase exploratory trials or large pivotal studies, GLOBAL ensures your protocol meets ICH, FDA, and other global regulatory expectations while setting your team up for successful execution and high-quality data integrity.

Customized Protocol Services for Every Trial Phase and Indication
‍At GLOBAL, we specialize in protocol development that reflects your clinical objectives and regulatory strategy. We collaborate closely with your team to balance scientific rigor, patient safety, and operational efficiency.

We can help you:

• Draft or revise protocols that align with your product development goals
• Ensure compliance with ICH E6(R2), GCP, FDA/EMA expectations, and therapeutic standards
• Write new protocols or adapt legacy versions for new populations or indications
• Harmonize protocol design with downstream documents such as Statistical Analysis Plans (SAPs), Investigator Brochures (IBs), and Clinical Study Reports (CSRs)
• Provide strategic input on study design, endpoints, and feasibility

Our milestones:

Our Clinical Trial Protocol Services Include:

Full Protocol Development

• Authoring new protocols for Phases I–IV and post-marketing studies
• Providing design input on objectives, endpoints, eligibility criteria, and assessments
• Integrating feasibility analysis, operational planning, and risk mitigation strategies
• Ensuring compliance with ICH E6(R2), GCP, and regional regulatory standards

Protocol Amendments and Adaptations

•  Modifying protocols to address updates, country-specific requirements, or operational needs
•  Ensuring streamlined version control and traceability documentation
• Aligning with evolving scientific or regulatory requirements

Review, QC, and Strategic Input

• Conducting scientific, regulatory, and operational quality control
• Reviewing content against therapeutic area norms and regulatory feedback
• Coordinating cross-functionally with clinical operations, regulatory, and biostatistics teams

Protocol-Related Deliverables

• Authoring study synopses (regulatory-facing or investigator-facing versions)
• Developing Protocol Deviation Plans and risk-mitigation strategies
• Integrating content with the Investigator’s Brochure (IB), Informed Consent Form (ICF), and Statistical Analysis Plan (SAP)

Why Choose GLOBAL for Protocol Support?

Experts in protocol writing across all phases and therapeutic areas

Deep knowledge of ICH, GCP, and global regulatory requirements

Real-world understanding of clinical-trial sites, CROs, and regulatory expectations

Seamless coordination with trial planning, timelines, and downstream documents

Flexible engagement models: full authoring, revisions, or QC-only support

Expert Protocol Support Across All Phases and Therapeutic Areas

Whether you're planning a first-in-human study, a pivotal trial, or a real-world evidence study, GLOBAL brings clarity and compliance to every step of your protocol development. Your trial’s success starts with the protocol. Let’s get it right—together.