Pharmaceutical and biotech companies benefit from working with external partners to manage pharmacovigilance activities. The breadth and scope of required services can depend on the mix of investigational and marketed products, the size of the company, and their comfort with outsourcing safety. Organizations realize a variety of benefits when collaborating with an external partner for safety services.
Outsourcing partner experts offer services in a wide range of areas, for instance, medical, regulatory, and technology, that are necessary for top quality safety surveillance and pharmacovigilance. Outsourcing provides rapid access to expert professionals, eliminating the need to hire, train, and retain staff.
Eliminate Burden of Implementing SOPs
Developing the right systems and SOPs to support long-term pharmacovigilance activities is very time-consuming and costly. Start-up or virtual pharma and biotech companies, in particular, look to external partners who have systems and procedures already in place, eliminating the time, risk, and expense of implementing company solutions. Outsourcing partner SOPs can be implemented quickly and are proven to pass regulatory inspections.
The right partner can conform to the needs of each unique company, and as the products progress through the development life cycle, can follow the company’s development plans to build a pragmatic and compliant system to meet requirements without incurring unnecessary expense.
Leverage Existing Resources
Service providers can “plug and play” into your systems or plug you into theirs. External partners can rapidly provide staff who have system, therapeutic, and regional expertise. Leveraging this expertise allows programs to be initiated quickly and to your specifications with the pharmacovigilance partner acting as an extension of the company. This allows the internal team to focus on their core competencies
An external partner can be used to complete all of your needs or a subset of activities, such as safety writing, literature review, local pharmacovigilance, and QPPV services in the EU, processing excess case volume.
In any model, the outsourcing of pharmacovigilance activities must be carefully planned to achieve success. With the right partner, collaboration takes place at every step in order to build strong processes and set clear expectations. This type of scalable, flexible, and efficient partnership will lead to a winning situation for all: the sponsor, the external partner, and the patients.
Are you PV ready? Evaluate your program using our complimentary safety readiness checklist here