During drug development, companies may utilize a variety of labeling-related tools that employ target labeling to facilitate drug development, while simultaneously aligning desired marketing and labeling objectives with the development program design or study design and drafting Clinical Overview (CO).
It is very 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 DCSI section that can conveniently be placed under these different clinical categories. Furthermore, DCSI develops into the 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 Clinical Overview (CO) comprising of scope and the 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
- Development and review of Developmental Core Data Sheets (DCDS) & DCS
- Development and review of FDA Target Product Profile (TPP), EU-draft SmPC (dSmPC)