During drug development, companies may utilize a variety of clinical labelling-related tools that employ target labelling to facilitate drug development, while simultaneously aligning desired marketing and labelling objectives with the development program design or study design and drafting the Clinical Overview (CO).
It is important for companies to employ a modular approach while collecting the evolving safety and efficacy information across various types of clinical labels. This would satisfy the need to help investigators and sponsors more effectively by presenting and updating a focused, dedicated Development Core Safety Information (DCSI) section that can conveniently be placed under these different clinical categories. Furthermore, DCSI develops into the Company Core Safety Information (CCSI) that is included in the first Company Core Data Sheet (CCDS) and is utilized for the product's entry into the market. Drafting a thoroughly versed CO comprising of scope and critical issues in the clinical developmental programme pertaining to the drug is also required to support the documentation for the assessors.
- Creation and review of Investigational Brochure (IB)
- Development of Target Labeling (TL)/Target Profile (TP)
- Development and review of Developmental Core Data Sheets (DCDS) & DCS
- Development and review of FDA Target Product Profile (TPP), EU-draft SmPC (dSmPC)