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Successful Partnering in Pharmacovigilance For Clinical Trials


Gary Barker, Denise Moody, Magda Santos and April Pierce provide insight into creating and keeping a successful pharmacovigilance partnership with a functional service provider.

Not only is the world in a constant state of flux, but the current pharmaceutical and clinical research environment is embroiled in significant change. As a result, business leaders are being forced to make significant decisions in new and innovative ways, all within the context of increasing regulatory and pharmacovigilance (PV) safety requirements. That includes creating resourcing models that emphasize a methodology that involves doing more with less, which can appear to run counter to actual business needs, but are needed to uncover the best methods to reduce drug development timelines and overall costs, while increasing the client’s return on investment.

One approach to meet those ends involves functional service provider (FSP) relationships. What is coming to the fore is the realization that by partnering with a well-established and experienced contract research organization (CRO) in an FSP approach that everyone can benefit from enhanced flexibility, consistency and experience that ultimately reduce time and costs without adversely affecting scientific/medical data integrity and quality. It’s been seen that partnering the right FSP with the right CRO can easily be a win-win situation for all the parties involved.

With that as a backdrop, PPD employees Gary Barker, Denise Moody, Magda Santos and April Pierce published an article in the May/June 2018 issue of Pharmaceutical Outsourcing highlighting the growth of a successful PV partnership between PPD and a biopharma company as the client increased its business footprint. The article outlines the advantages of partnering with an experienced and resilient CRO to support and facilitate change and growth. The authors detail the various stages of the partnership growth and the operational strategies devised to achieve the objectives of the client as its business developed. In addition, they explore how the operational delivery model provided the right level of client oversight, while also enabling flexibility, quality and compliance in a cost-effective manner at the various stages of the client’s expansion.

Together, PPD and the biopharma company have built a solid partnership over more than 10 years. As the client has experienced growth and success, it has relied on PPD to manage its increasing case volumes, which continues to support and embellish the business relationship. Over the course of the partnership, case processing workload has increased by 98 percent, along with additional scope in providing literature surveillance as well as clinical trial safety report submissions. In the midst of climbing case volume and scope of services, PPD has continued to maintain a high level of quality as evidenced by a 2017 case quality review score of around 98 percent and a 2017 regulatory safety reporting compliance score of better than 99 percent. Currently, PPD utilizes more than 200 dedicated staff across four locations to successfully meet this partner’s needs.

Gary Barker, senior director in PV; Denise Moody, senior director in project management; Magda Santos, director in PV; and April Pierce, senior director in PV.