Investigator’s Brochure Translation; IB Translation

During the drug development and approval process, good clinical practice and regulatory compliance demand careful recording of clinical and non-clinical data in documents. Investigator’s Brochure (IB) are complex documents that provide investigators and ethics committees with a broad overview of a product’s development. All investigator brochures will be prepared in accordance with Appendix I (Investigator Brochure Format and Contents) which provides a model for the standard requirements. It is used by investigators to ensure protocol compliance and is often submitted to regulatory bodies as part of new drug applications.