Case Study: Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates
Background – Client Needs:
A multinational pharmaceutical company
Europe, US, Canada
The client sought out a partner to create Company Core Data Sheets for a portfolio of products, including authoring CCDS documents from scratch, as well as review and updates to existing CCDS documents.
The client faced the following challenges:
The scope of Celegence’s activities was the creation and maintenance of the CCDS, through a team of experienced medical writers and medical reviewers with a good understanding of the processes and templates for CCDS used in the pharmaceutical industry and knowledge on the current regulatory environment.
Project Initiation & Key Objectives:
The client chose to leverage Celegence’s team of regulatory experts to support the CCDS creation and update based on our expertise and an operating model designed to deliver an end-to-end cost effective solution.
The client’s objectives involved realising the following business benefits via their outsourcing strategy:
Celegence Solution & Approach:
Celegence was awarded a contract for the creation of Company Core Data Sheet
Before initiation of the activities, a CCDS template was developed. The CCDS template was such that it would be easy for regulators to find specific information.
The activities performed as a part of the process are listed below:
The final output from Celegence was a CCDS with up to date and consistent safety and efficacy information. Along with the CCDS, documentation was also provided as part of the process, such as literature search output, case report evaluations and HA recommendations.
The key to success of the project was proactive planning, an effective end-to-end process and good communication, discussion, and the exchange of information between SMEs and the client POC, all aiding in the commitment to meet the ultimate goal of patient safety.
Key Project Achievements
Celegence delivered the following value and business impact to the client:
An important part of CCDS creation is the preparation of core safety information (CSI), as this information must be available to submit with the PSURs. Regulators need to know what changes have been performed by the MAH during the time period of the PSUR for companies that have a product sold in multiple countries, having a CCDS, which includes the CCSI, is the sensible approach. If a change is performed in CCSI, it would drive changes in the local product information throughout the world. The process helps in coordinating the maintenance of safety information helping achieve the same safety standards for regulators, prescribers and the patients ultimately improving patient safety.