Linical Unifies Safety Operations
to Scale Global Case Processing

Sponsors increasingly demand their internal safety teams and CRO partners to assess safety information in real time, with AI playing a growing role in improving processes. At the same time, sponsors and CROs must keep pace with evolving regulatory requirements across global health authorities, including Japan’s PMDA, especially as expectations around AI develop. For Linical, a global CRO, with expertise in Japan and a presence across Asia-Pacific (APAC), Europe, and the Americas, this creates a dual challenge: meeting Japan’s regulatory requirements while delivering the faster, more transparent case processing sponsors expect.

Linical recognized that legacy safety databases could not meet these expectations. It was difficult to update workflows to support newer technologies, leading to workarounds and patchwork solutions that hindered case processing, visibility, and collaboration between Linical and its sponsors. Managing both PMDA and global requirements added further complexity, driving Linical to search for a new solution. The CRO selected Veeva Safety, a global unified solution that connects safety to other functional areas like clinical and keeps pace with evolving regulations and technology innovations.

One safety system for PMDA, FDA, and EMA

Linical serves a global customer base and manages cases for submissions to regulatory authorities around the world. Previously, Linical had two separate databases and submission workflows – one for FDA and EMA, and one for PMDA. “Submitting the Individual Case Safety Report (ICSR) to the PMDA within legacy systems required such a significant manual effort. The systems lacked automated mapping and integrated validation, which taxed our resources and increased our operational risk,” said Christina Gross, director of pharmacovigilance, Linical.

Without a direct connection to the PMDA, submissions were completed outside the safety system, requiring case processors to manually enter acknowledgements back into Linical’s database. While the Linical team managed to meet regulatory timelines, the process increased operational risks and potential data discrepancies and was not scalable.

Accelerating case processing with automation

With Veeva Safety, Linical brought global and local case processing into one solution that established a single source of truth for safety data and streamlined processes. “Eliminating all of those manual workarounds freed up the time for our PV officers to understand the regulatory requirements, for each case, that are constantly changing,” said Gross.

A secure connection to the PMDA automated the reconciliation of global and local data and validated regulatory workflows. Automating submissions reduced the risk of file format and communication errors between Linical and the PMDA.

Bringing all case data together in a single database also connects teams across time zones and eliminates duplicative data entry. “Our local cases, especially in Japan, come from different time zones. PV officers are now able to pick up cases and process it right there, without worrying about when the case comes in. The amount of time saved is incredible,” said Gross.

The efficiency gains across case processing and submissions helped Linical do and manage more without increasing headcount. Additionally, the safety team can manage or update all reports without relying on the service team to make every change. “All of the technology and information is in the Veeva solution, so I don’t have to worry about it. I can focus on the submissions and where things are in the life cycle. It’s all within the system, and I can pull it right out. It’s amazing,” said Gross.

Increasing transparency, speed, and data quality for sponsors

Japan’s unique regulatory requirements can make case processing difficult for sponsors. Linical’s validated and scalable Veeva Safety PMDA connection supports sponsors’ Japan reporting needs with a direct, integrated gateway. With a global safety solution that has built-in connections for regulatory agencies around the world, Linical can rapidly onboard new sponsors and provide greater visibility into case progress.

Veeva Safety also gives Linical flexibility to quickly adapt to new study requirements and build customized reports for sponsors. Previously with a legacy system, customized reports required significant overhead and support from external vendors. Now, the Linical safety team can easily build reports directly within Veeva Safety, accelerating study start times and better supporting sponsors.

Continuing to increase speed and efficiencies with Veeva Connections and AI

Linical continues to expand automation with Veeva Connections and AI. Implementing the Veeva Safety-EDC Connection will establish a direct flow of adverse event and subject data from Veeva EDC to Veeva Safety, therein eliminating duplicate data entry, improving data quality, and significantly reducing manual data reconciliation and case processing times. It also will strengthen the safety data foundation for AI.

AI will drive greater automation across end-to-end safety processes. “The release of AI agents will further strengthen our existing capabilities for automated intake, narrative generation, and rule-based narratives,” said Gross. Together these advances will help Linical scale global safety operations while delivering greater speed and efficiency for sponsors.

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