Investigator’s Brochure Services
Supporting safe, compliant, and well-informed clinical research.
An Investigator’s Brochure (IB) provides essential information about an investigational product (IP), whether a medicinal compound, biologic, device, or other therapeutic intervention. It ensures investigators and trial personnel are equipped with the scientific background needed to conduct the study safely and ethically.
A high-quality Investigator’s Brochure (IB) is far more than a regulatory requirement. It’s a vital tool for protecting patients, supporting investigators, and ensuring trials run safely and effectively. Our medical writing team delivers expertly crafted IBs and IB updates that are accurate, compliant, and tailored to your product’s development stage
Our Investigator's Brochure Services
QInscribe provides comprehensive support for both new IBs and periodic updates. Our services include:
- Full IB Authoring
From initial drafts to final, submission-ready documents, we’ll work with your team to produce compliant IBs. - Updates & Annual Revisions
We support your team through changes to your existing documentation, including integration of new clinical or safety data. - Stakeholder Engagement
We’ll coordinate with SMEs across functions to ensure complete, accurate input. - Therapeutic Area Expertise
Our medical writers have experience in oncology, rare diseases, neurology, infectious disease, immunology, cardiology, and more. - Document Accuracy & Alignment
Our rigorous QC oversees content consistency across sections and assures alignment with existing templates. - Flexible Workflows
Whether you prefer us to work within your established SOPs, or follow QInscribe’s proven processes, we’ll adapt to the needs of your team and trial. - Global Regulatory Alignment
Under our regulatory guidance, you can rest assured that your documents will be ready for submission to all major health authorities. - Scalable Support
From early-phase FIH compounds to late-phase investigational products, we cover all phases and can scale to any trial size.
What You Gain by Partnering with QInscribe
Deep Regulatory Knowledge
Our medical writing experts are well-versed in crafting documents compliant with ICH E6(R2), FDA, EMA, and EU CTR guidelines.
Clear, Scientific Communication
We’ll translate your complex findings into precise, accessible content, ready for review and auditing.
Cross-Functional Coordination
Engage your stakeholders across clinical, safety, and regulatory functions with our clear, concise documentation.
Time-Sensitive Delivery
We balance accuracy with tight timelines for submission and site activation, never compromising quality in the process.
Let’s build better brochures together.
Our team works closely with yours to deliver timely, high-quality documentation that protects participants and empowers your clinical teams.