Oncology Development Program:
Pharmacovigilance Transition and Scale-Up Support.
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Summary.
Arriello successfully supported a US biotechnology company through a complex transition of pharmacovigilance operations during the progression of its oncology development program. Taking over studies from previous providers, Arriello managed the migration of safety data, aligned operational processes, and established robust pharmacovigilance oversight.
As the program advanced from Phase I to Phase III, the client expanded Arriello’s scope of work, reflecting growing confidence in the team’s expertise and delivery capabilities. Arriello continues to support the client through ongoing clinical development activities and safety operations.
Challenges.
The client had previously worked with multiple pharmacovigilance vendors before transitioning to Arriello. This created a number of operational challenges, including:
- Migration and set up of existing studies and safety data from previous providers.
- Transition of more than 100 historical safety cases with limited support from incumbent vendors.
- Maintaining alignment with site processes and safety reporting workflows that had already been established.
- Addressing discrepancies and reconciliation issues between clinical and safety databases.
- Supporting a client team undergoing personnel changes while ensuring continuity of pharmacovigilance activities.
- Balancing the need for data quality improvements without creating unnecessary burden for investigative sites.
Solution.
Arriello implemented a structured pharmacovigilance transition strategy designed to maintain study continuity while improving operational oversight.
Our team:
- Managed the migration and setup of ongoing clinical studies and historical safety data.
- Adapted pharmacovigilance procedures and documentation to align with previously agreed site and sponsor processes.
- Developed practical solutions to improve reconciliation between clinical and safety databases.
- Provided pharmacovigilance training and system guidance to client personnel, including support for sponsor review activities within the safety database.
- Demonstrated flexibility as client stakeholders and operational requirements evolved throughout the program.
- Established project-specific operational guidance to ensure alignment between Arriello and client teams and support consistent delivery.
Through proactive collaboration and responsiveness, Arriello helped strengthen operational performance while maintaining continuity across the client’s expanding clinical program.
The team worked closely with key stakeholders to address emerging challenges and implement process improvements. At the same time we ensured pharmacovigilance activities remained aligned with study requirements, which evolved gradually.
This collaborative approach enabled scalable support as the development program progressed through successive clinical phases.
Our Holistic Approach.
Arriello’s approach involved assembling a team of PV experts and experienced project managers to utilize project management tools to oversee key milestones.
This ensured adherence to timelines and PV requirements. By providing a clear communication path, efficiency was achieved, exceeding the client’s expectations and timelines.
Need scalable pharmacovigilance support for your clinical development program?
Whether you are transitioning from another provider, scaling clinical studies or strengthening safety operations, Arriello can help ensure continuity, compliance and efficient delivery.
Contact Arriello today.
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