Investigator Brochures
Comprehensive, scientifically rigorous investigator brochures that effectively communicate your product's profile to clinical investigators.
Comprehensive Investigator Brochure Development
Investigator Brochures (IBs) are critical documents that provide clinical investigators with the information necessary to understand the rationale for, and requirements of, your clinical trial. EloquiMed specializes in developing clear, concise, and compliant IBs for all clinical development phases.
Our team of experienced medical writers transform complex scientific data into accessible information that enables investigators to:
- Understand the scientific basis for the proposed clinical investigation
- Assess the anticipated risks and benefits for study participants
- Comprehend dosing regimens, monitoring procedures, and potential adverse events
- Make informed decisions on protocol adherence and patient management
- Fulfill regulatory and ethical requirements for trial participation
ICH Guidelines
ICH E6 GCP compliance for worldwide acceptance
Regulatory Requirements
FDA, EMA, PMDA, and other global authority standards
Current Scientific Knowledge
Up-to-date scientific context and reference standards
Development Phase Specifics
Tailored content from First-in-Human to late-phase trials
Our Investigator Brochure Services
Comprehensive solutions for creating and maintaining high-quality Investigator Brochures throughout the clinical development lifecycle
Specialized IBs for Phase I trials that effectively communicate preclinical data and early safety parameters to support initial human dosing.
Comprehensive IBs incorporating early clinical findings, dose selection rationale, and updated safety profiles for later-stage trials.
Specialized expertise in developing IBs for complex biologics, ADCs, cell therapies, and novel platform technologies.
Our Approach to IB Development
A methodical process ensuring scientifically accurate, regulatory compliant, and user-friendly Investigator Brochures
Data Assessment
Comprehensive review of available data including preclinical studies, clinical trials, published literature, and regulatory correspondence.
Content Planning
Strategic organization of content to highlight key messages while ensuring compliance with regulatory requirements and guidelines.
Development
Creation of scientifically accurate content with clear data visualizations by specialized medical writers with relevant therapeutic expertise.
Quality Control
Rigorous review process including scientific accuracy verification, regulatory compliance checks, and editorial quality assurance.
Key Elements of Our IBs
EloquiMed's Investigator Brochures are meticulously crafted to include all essential elements while maintaining clarity and focus.
Detailed chemical/biological properties, formulation data, and manufacturing information with appropriate level of detail.
Strategic presentation of pharmacology, toxicology, and ADME studies with focus on clinical relevance.
Well-structured presentation of clinical study results with appropriate data visualizations and interpretation.
Practical risk management information for investigators including monitoring requirements and adverse event management.
Case Study: IB Excellence
How EloquiMed streamlined IB development for a complex biologics program
Challenge
A biotech company developing a novel antibody-drug conjugate (ADC) needed a comprehensive IB for their first-in-human study. The molecule had a complex mechanism of action and preliminary toxicity findings requiring careful communication.
Solution
Scientific Expertise
Assigned writers with specific ADC and oncology experience who could interpret complex preclinical data.
Visual Communication
Developed custom illustrations explaining the unique mechanism of action and target engagement.
Risk Management Focus
Created detailed guidance for managing novel toxicities based on limited preclinical data.
Regulatory Strategy
Incorporated regulatory feedback from pre-IND meeting to address specific concerns proactively.
Results
Zero
IB-related clinical holds or safety concerns
98%
First-round acceptance rate by ethics committees
3 weeks
Development time from kick-off to final delivery
5+
Successful annual updates across study evolution
EloquiMed's expert approach to our complex IB helped our investigators fully understand our novel therapy. This was instrumental in the smooth initiation of our FIH study and ongoing program success.
Frequently Asked Questions
Common questions about our Investigator Brochure services
Typical timelines range from 3-6 weeks depending on complexity, data availability, and review cycles. For urgent needs, we can implement expedited timelines with dedicated resources.
We work with you to determine the appropriate level of detail while maintaining necessary confidentiality. All our writers operate under strict confidentiality agreements, and we can implement custom security protocols for highly sensitive programs.
IBs should be updated at least annually or whenever significant new safety information becomes available. We help clients establish update schedules aligned with their development timeline and data availability.
Yes, we develop IBs that meet global requirements while accommodating regional differences when necessary. We can prepare region-specific addenda for special markets while maintaining a consistent core document.
Ready to develop your next Investigator Brochure?
Contact EloquiMed today to discuss how our expert medical writers can support your clinical development program with high-quality, compliant Investigator Brochures.