Essential documents for efficient clinical trial conduct
Well-designed clinical trial documents set the foundation for successful study execution. Clear protocols reduce protocol deviations. Comprehensive investigator brochures support informed consent and site training. Thoughtful development plans align your clinical program with regulatory expectations. ESW Communications develops these essential documents with attention to both scientific rigor and operational practicality.
We develop protocols that clearly communicate study objectives, design, and procedures. Our protocols are designed for operational clarity, reducing site questions and protocol deviations while meeting regulatory requirements.
The IB compiles nonclinical and clinical information needed for investigators to understand your product. We develop new IBs and manage updates as your clinical program generates new data.
We develop informed consent documents that communicate study requirements, risks, and benefits in language appropriate for study participants. We balance regulatory requirements with readability.
Strategic documents outlining your overall clinical development strategy from early development through registration. We help articulate your development rationale and regulatory pathway.
Eligibility criteria that can be consistently applied across sites.
Endpoint definitions that leave no room for interpretation.
Visit schedules and assessment windows that work in real clinical settings.
Comprehensive safety monitoring procedures to protect participants.
Statistical methods aligned with regulatory expectations.
We develop clinical trial documents with both regulatory compliance and operational practicality in mind. Our writers understand that these documents must work in real-world clinical settings, not just on paper. We focus on clarity, consistency, and completeness while avoiding unnecessary complexity that can lead to site confusion and protocol deviations.
Timeline depends on study complexity and internal review processes. A typical protocol requires 8-12 weeks from kickoff to final version. We can work on accelerated timelines when needed, and can develop protocol synopses in parallel with full protocol development.
We track changes clearly and ensure amendments maintain consistency with the original protocol. We work with your regulatory team to determine the appropriate scope of amendments and support submission to health authorities and ethics committees.
Yes. We manage IB updates as new data become available, ensuring consistency with previous versions while incorporating new safety and efficacy information. We track line listings of significant changes and support annual review cycles.
Contact ESW Communications to discuss your document needs.
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