Pharmacovigilance (PV) Outsourcing — New PV business models.

Introduction

Pharmacovigilance (PV) outsourcing is the mainstay solution for small to medium size businesses.

Pharmacovigilance outsourcing (PVO) transfers the execution of drug safety functions and processes to a third-party service provider. These include primary PV activities like case processing, as well as governance activities like compliance management. The operations ultimately outsourced depend upon criteria that differ by organization. Core activities include:

• Collecting adverse drug reaction (ADR) data and information
• Case processing activities
• Preparing and developing Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategies (REMS)
• Creating and submitting expedited and aggregate PV reports Management activities include:
•  Preparing standard operating procedures (SOPs) and other controlled quality documents
• Assisting with internal and external compliance reporting
• Testing and monitoring business processes and systems for compliance

Performing trend analyses and predictive modelling for compliance operations

• Preparing detailed descriptions of the Pharmacovigilance System

Potential benefits of PV outsourcing.

Having looked at the core activities, let’s explore the merits of PV outsourcing

•   Convert fixed resource costs into variable, workload-dependent charges
•  Reduce the number of resources to recruit, manage, and / or train
• •Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge
• Improved efficiencies and Return on Investment (ROI)
• Benefits extend beyond cost savings and address three common pain points:
• Talent shortages: Maintaining compliance amidst increasing regulatory complexity, especially in a global context, requires individuals skilled in risk management and knowledgeable of regulatory and compliance operations; these professionals are in short supply and in high demand. Organizations are struggling to increase operational budgets to provide training and gain access to an extended talent pool.
• Sub-optimal compliance processes: Organizations want to focus on improving and streamlining their compliance processes to make them more predictable; however, continual changes in the regulatory landscape can undermine compliance process investments, leading to suboptimal and non-compliant processes. This may result in higher compliance costs (i.e., through rework) and lower quality levels.
• Technology infrastructure investments: Organizations are constantly investing in technology and related infrastructure to help meet compliance needs. With frequent changes to existing regulations, as well as the introduction of new regulations, frequent technology investments are needed to keep pace.

 Conclusion

Wondering where to outsource pharmacovigilance services? Jeyflex Consultants Ltd is here to walk with you.