Bureau of Industry and Security (BIS) Business Partnership and Global Patient Safety

A young, rapidly expanding biotech company has been in commercial operation for approximately three years. As it matured, the need to enhance its pharmacovigilance activities became apparent. Business and IT organizations partnered to oversee and guide the efforts, which involved a vendor transition, with technical activities being driven by the new vendor.

The company’s pharmacovigilance activities were being managed in a multi-tenant environment, which restricted the ability to oversee and appropriately manage both system administration and business operations. As the company grew, they recognized the necessity for a dedicated, single-tenant system to accommodate their expanding operations, which would continue to be outsourced, but with greater visibility and management. In addition to issues with case processing, a non-validated spreadsheet application was in use for signal management, raising significant compliance concerns.

Core challenges were data migration, GxP compliance, and organizational, as the situation required introducing a BIS representative into the Patient Safety (adverse event) department – a department that had been accustomed to operating independently due to the outsourcing of its main systems.

To address these challenges, Osprey Life Sciences assumed the role of internal business relationship manager, facilitating partner oversight and fostering a relationship between the BIS and the Global Patient Safety function. This transition involved moving to a new single-tenant vendor system, with Osprey playing a pivotal role in ensuring data integrity. Osprey’s expertise in regulatory expectations guaranteed that all processes, testing, and documentation met required standards. Moreover, a doting focus was placed on improving oversight and governance, achieved through collaboration with BIS e-Compliance (validation) and Computer Systems Quality organizations.

For signal management, Osprey Life Sciences participated in the RFP vendor selection process, provided business analysis resources, and oversaw vendor activities. A new, compliant, single-tenant solution was implemented with integration to external and internal data sources.

It was essential to establish the business partner role in the patient safety department, providing not just internal technical solutions and standards to the department, but also increased awareness of patient safety requirements and operations across the BIS organization.