Investigational Brochure (IB)

An Investigational Brochure (IB) is a cornerstone document that provides comprehensive, up-to-date information about an investigational product, supporting investigators, ethics committees, and regulatory authorities in understanding the product’s development and clinical context. At GCT, we leverage our scientific writing expertise and regulatory knowledge to create IBs that are accurate, clear, and fully aligned with international standards.

Our IB preparation process begins with a review of preclinical and clinical data, relevant literature, and trial-specific information. We collaborate with therapeutic area experts to ensure that the IB presents complex scientific information in a clear, organized, and reader-friendly manner. Tables, flowcharts, diagrams, and summary tables are used strategically to enhance comprehension and usability.

We provide ongoing support for IB updates throughout the clinical development lifecycle, incorporating new data from ongoing studies, safety findings, or regulatory guidance. This ensures that investigators and stakeholders always have access to the most current and accurate information.

Our team emphasizes clear and transparent communication of potential risks, adverse events, and safety considerations, helping investigators and ethics committees make informed decisions and supporting compliance with global safety standards.

We ensure that every IB aligns with ICH guidelines and is prepared to meet the requirements of multiple regulatory authorities. This facilitates regulatory acceptance across regions and supports the smooth execution of multinational trials.

Partner with GCT to develop IBs that are scientifically rigorous, up-to-date, and regulatory-ready—providing investigators and stakeholders with the clarity and confidence needed to conduct safe and successful clinical trials.