TraceLink Implementation Case Study: Serialization Strategy for a Pre-Commercial Company
In this TraceLink implementation case study, Clarkston Consulting recently partnered with a pre-commercial biopharma company on a serialization strategy. Read a synopsis of the project below or download the full case study.
Download the TraceLink Implementation Case Study Here
Clarkston was engaged by a pre-commercial biopharmaceutical company that develops medications for genetic diseases to support their serialization efforts. They were progressing toward their first significant commercial launch in the U.S., and as part of the preparation, needed to be Drug Supply Chain Security Act (DSCSA) compliant. Because of Clarkston’s success in supporting the client’s supply chain and quality commercialization readiness and our deep serialization expertise, the client engaged Clarkston to lead the development of a serialization strategy, business processes and system implementation.
The client had already selected TraceLink as its serialization solution but needed to stand up business practices that would enable their U.S. commercial launch and position them for future country launches. They also needed support in implementing TraceLink, including the creation of master data, onboarding partners, and executing validated testing.
Clarkston first gained insight into the client’s processes and business needs and then developed a timeline of serialization activities that would take place to support the U.S launch and future European launches. This strategy was revisited as business needs continued to develop. When possible, deliverables were developed with considerations for future markets to help the client streamline implementation efforts over time. During the implementation, Clarkston’s serialization subject matter experts supported the creation of requirements and guided design work with TraceLink. Clarkston also led the computer system validation efforts and related partner testing, helped the client define their serialization processes, and created the necessary documentation to support compliance.
Given that serialization was only part of the client’s roadmap to commercialization, cross-functional alignment was key to a successful solution. Clarkston coordinated work with their ERP implementation team and QMS team to avoid duplication of efforts and ensure that all solutions were positioned to support their first drug launch and market access.
Download the TraceLink implementation case study, and learn more about our Serialization and Traceability Consulting Services by contacting us below.
Contributions by Madeline Egbert
