A global pharmaceutical company was developing a product across a long-running clinical program. Rather than appointing a new pharmacovigilance provider at each development stage, the sponsor worked with SGS as the one dedicated pharmacovigilance partner from first-in-human studies through post-marketing for the same product.
Over 15 years, the scope expanded alongside the product and spanned multiple ownership transfers. The partnership covered clinical trial safety, ongoing case processing, regulatory reporting and post-marketing pharmacovigilance. Case volumes grew from dozens of reports in the early years to hundreds and, following marketing approval, several thousand reports annually. In total, SGS processed more than 8,000 cases during the program.
Maintaining pharmacovigilance continuity across the product lifecycle
The challenge was not only the volume of safety work. Successive product owners needed to preserve knowledge built up over many years, studies and regulatory milestones. A new safety case could not always be assessed in isolation. Its relevance might depend on previous cases, earlier medical reviews, exposure data and historical reporting decisions. Replacing teams or providers during the program would have increased handovers and made that context harder to retain. Each owner therefore needed a pharmacovigilance model that combined operational capacity with long-term stewardship of the product’s safety history and ultimately benefited from the continuity it provided.
Keeping pharmacovigilance stable as ownership changed
During the product lifecycle, the product changed ownership several times through licensing agreements and portfolio transfers. Each new owner brought different teams, governance structures, systems and operational expectations. Despite these changes, we continued to support the product’s pharmacovigilance activities, with key performance indicators remaining above 98% This gave each new owner access to a team that already understood the product, its safety profile and history such as the reasoning behind previous medical and regulatory decisions.
That continuity reduced the need to rebuild knowledge after every transfer. It also limited repeated onboarding, handovers and vendor transitions at moments when the new owner already faced pressure to integrate the asset into its organization.
Building product knowledge over time
We assigned a dedicated pharmacovigilance team that remained involved as the program progressed from early clinical development to post-marketing. The team supported case processing, medical review, safety surveillance, regulatory reporting, aggregate reporting and safety writing. Because the partnership continued across development phases and ownership changes, knowledge of the product, previous cases and reporting decisions could be carried forward rather than rebuilt for each new study. This continuity also helped successive owners work across changing clinical CROs, internal teams and external partners while maintaining one consistent pharmacovigilance approach.
Managing safety database migrations without interrupting case processing
During more than 15 years of continuous support for the product across multiple ownership transfers, safety systems, technical standards and organizational requirements inevitably evolved. Ownership changes also introduced new system environments and operating models, making several safety database migrations necessary throughout the product’s lifecycle.
These transitions had to take place without disrupting ongoing case processing, follow-up activities or regulatory reporting. We planned and executed the migrations while continuing to support active pharmacovigilance operations, coordinating the transfer of data between source systems, target environments and the active pharmacovigilance team, while keeping historical data complete, traceable and available throughout each transition.
The largest migration involved the transfer of approximately 10,000 cases to a new safety database, including historical cases originating outside the scope of SGS case processing. All migrations were completed without interruption to case processing, allowing the safety setup to evolve with new technologies, systems and owners while maintaining business continuity and regulatory timelines.
A consistent safety model across clinical development and post-marketing
A consistent pharmacovigilance operating model provided a stable framework across studies, development phases and ownership changes. New trials and post-marketing activities could therefore be integrated into an established model rather than requiring a separate setup each time.
The long-term partnership also reduced repeated onboarding and preserved the reasoning behind historical safety decisions. This became increasingly valuable as the case volumes, stakeholders and regulatory obligations grew.
A pharmacovigilance partnership built around the product
This case demonstrates the value of continuity at the product level. While ownership, systems, and operating models may evolve over time, maintaining the same pharmacovigilance partner helps preserve critical safety knowledge, historical context, and a deep understanding of the product’s safety profile. This continuity supports a seamless transition, reduces knowledge loss, and enables informed, consistent safety oversight throughout the product lifecycle.
