A leading life sciences firm found significant compliance issues with one of their patient communication vendors. We provided project management and oversight for extensive remediation efforts across numerous departments and outside vendors. Our team was able to implement a series of corrective and preventive actions that resolved the ongoing issues and installed controls to avoid similar problems in the future.
An industry-leading Fortune 100 pharmaceutical firm transitioned to a new vendor to manage its largest Customer Engagement Program (CEP), a charitable patient assistance initiative that provides access to medicines for free or at a savings. Within three weeks of the new vendor launch, the client discovered Adverse Event (AE) reporting compliance gaps and other issues related to the vendor’s operations, technology and human resources. The client hired us to organize full remediation of the program activities and mitigation of associated quality risks at an enterprise level. We were engaged to complete this project based upon having substantial expertise in pharmacovigilance, remediation, and expert capabilities in project, program, and risk management.
We took an agile approach and established an over-arching PMO to manage the entirety of the remediation. A governance structure was implemented to clearly identify the right point-of-contact for all internal and external stakeholders. Over the six-month course of the engagement, to address tactical issues outstanding and new, we led a daily scrum with 30+ participants to resolve matters real-time, in an immediate fashion. The PMO was responsible for facilitating all Steering Committee meetings and keeping senior management informed; delivered through weekly reports and creating meaningful metrics to assist the various stakeholders in timely decision-making. To restore compliance at the enterprise level, our team conducted a comprehensive Root Cause Analysis and subsequently produced eleven Corrective and Preventive Actions (CAPAs). The work of the PMO and CAPAs were designed to close all gaps and bring AE reporting back into compliance. The PMO established the necessary project plans, working groups, and ensured the CAPAs were completed on schedule and documented fully for inspection purposes. All needed documentation regarding the remediation was collected and files carefully archived to satisfy internal policies and external regulations. This was a highly complex project involving multiple stakeholders, teams across four countries and time sensitive information.
We successfully implemented process improvement through eleven corrective and preventive actions to ensure the same type of compliance event does not reoccur. Performance management efforts engaged with the client’s three vendors yielded a +5% collective improvement in the program’s AE reporting rate. In addition, we supported the client during the European Medicines Agency (EMA) inspection, leading to a successful conclusion. Key high risk aspects of the program were carefully transitioned to a trusted vendor experienced in pharmacovigilance. This process change coupled with extensive retraining and new performance management procedures allowed the vendor being remediated to pass numerous client quality checks and transition back to business as usual.