Clinical Protocol Development
Expert development of clear, compliant, and scientifically sound clinical trial protocols to drive your drug development success.
Comprehensive Protocol Development Solutions
Clinical trial protocols are the foundation of a successful study and regulatory submission. EloquiMed specializes in developing scientifically sound, operationally feasible, and regulatory-compliant protocols for all phases of clinical development.
Scientifically Rigorous
Thorough scientific rationale and robust methodology that withstands regulatory scrutiny.
Operationally Feasible
Practical protocols that balance scientific rigor with real-world implementation considerations.
Regulatory Compliant
Adherence to ICH, FDA, EMA and other regulatory guidelines and requirements.
Publication Ready
Clear methodology and design elements ready for future publication considerations.
Our experienced medical writers work closely with your clinical and scientific teams to create protocols that:
- Clearly articulate scientific rationale and study objectives
- Define precise eligibility criteria and endpoints aligned with development goals
- Incorporate appropriate statistical methodologies and analysis plans
- Address potential risks with comprehensive safety monitoring plans
- Meet regulatory requirements across global regions
- Optimize operational feasibility while maintaining scientific rigor
Our Protocol Development Services
Comprehensive solutions for all types of protocols across the clinical development lifecycle
Expert development of FIH, SAD/MAD, food effect, DDI, and other early phase protocols with appropriate safety monitoring and stopping criteria.
Strategically designed dose-finding, POC, and early efficacy protocols with appropriate endpoints and biomarker strategies.
Comprehensive pivotal trial protocols with robust design, appropriate endpoints, and statistical power to support registration.
Post-approval study protocols including PASS, PAES, registry studies, and real-world evidence generation.
Our Protocol Development Approach
A collaborative, structured process ensuring scientifically sound, operationally feasible protocols
Thorough understanding of study objectives, development strategy, target population, and regulatory requirements.
Collaboration with clinical, scientific, statistical, and operational stakeholders to define key elements.
Development of protocol by specialized medical writers with therapeutic area expertise and regulatory knowledge.
Iterative review process with all stakeholders to ensure scientific accuracy, clarity, and operational feasibility.
Quality control with regulatory compliance check, editorial review, and final formatting for implementation.
Elements of Protocol Excellence
EloquiMed's protocol development incorporates key elements that ensure both scientific rigor and operational success.
Case Study: Complex Protocol Development
How EloquiMed developed an innovative adaptive protocol for a challenging rare disease program
Challenge
A biotech company was developing a novel therapy for a rare neurodegenerative disease with significant heterogeneity. The client needed a protocol that could accommodate the small patient population, address multiple primary endpoints, and incorporate biomarker-driven stratification—all while meeting global regulatory requirements.
“EloquiMed transformed our complex clinical development challenge into an elegant protocol that satisfied both scientific and regulatory requirements. Their strategic thinking and clear writing were instrumental to our successful study initiation.”
Protocol Development Across Therapeutic Areas
Our therapeutic area specialists ensure protocols meet the unique requirements of each field
Frequently Asked Questions
Common questions about our protocol development services
How long does protocol development take?
Timeline depends on study complexity and client review cycles. Typically, we deliver standard protocols within 3-6 weeks from kickoff to final version, with expedited options available for urgent needs.
Can you work with our existing templates?
Yes, we can work with your existing templates or develop custom ones aligned with your corporate style. We ensure all regulatory requirements are met regardless of the template format.
How do you handle statistical sections?
We collaborate closely with your statisticians or our statistical consultants to develop appropriate statistical methodologies, sample size calculations, and analysis plans aligned with study objectives.
Do you support health authority interactions?
Yes, we can prepare protocol synopses and other documentation for health authority interactions, as well as address protocol-related questions that arise during regulatory reviews.
Ready to develop your next clinical protocol?
Contact EloquiMed today to discuss how our protocol development experts can support your clinical development program.