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Key Considerations When Evaluating Pharmacovigilance System Providers (Part 1)

Your choice of Pharmacovigilance system providers will impact your safety program for years into the future. In the near term, however, a system chosen without the appropriate awareness of installation requirements—and limitations—could bust your budget and disrupt your timetable. Although system functionality typically dominates the selection criteria, each candidate system vendor has certain characteristics that we have learned to factor into the selection process as early as possible before determining the optimal fit. Astrix’s direct experience with assisting clients to select their Pharmacovigilance system providers, combined with our policies of vendor neutrality and absence of financial interest, enables us to offer insights to assist you throughout the entire process of selecting the company that’s best suited to serve your organization’s unique needs and preferences:

  1. Global Compliance – While all systems must meet the same Global Regulatory requirements, it is important to know each company’s timeliness for, and focus on, maintaining global regulatory compliance.  For example, some companies may be more focused on a geographical area due to client needs.  Make sure that the regulatory focus of each vendor whose system you choose to evaluate is closely aligned with your near-term and potential long-term needs.
  2. Experience – Some key aspects of client service are enabled—by a vendor’s direct experience as evidenced by their longevity in business.  While the length of time in this space doesn’t necessarily mean they are the better vendor, it is an objectively reliable indicator of their ability to make good on their commitment to clients’ satisfaction. Some newer vendor systems might incorporate the latest technology better than some of the long-standing existing systems but will their client bases—and commitment to this space—still be here in the next five or ten years?  Each vendor’s history and apparent sustainability should be examined.
  3. Company Culture – Consistency within the client service account team enables a level of comfort and confidence that is quite valuable. A vendor that keeps its employees happy and excited to be part of the company will have longer retention which, in turn, means a more knowledgeable team that brings deeper experiences to understanding their clients’ needs.  One characteristic of a strong supplier partner is the respect and professionalism they’ve demonstrated for their employees over time.
  4. System Compatibility – Prior to a system demonstration, it is important to know whether the prospective supplier partner has clients with products, processes, and requirements consistent with yours. If, for example, you are the first (or only) vaccine company in their client portfolio, can you be assured that their expertise will adequately and rapidly incorporate new requirements and resolve defects impacting your operation—and be prioritized to meet your unique needs?

About Astrix’s Pharmacovigilance Practice

Astrix provides strategic consulting services that enable the success of end-to-end Pharmacovigilance (“PV”) planning, design, and implementation as part of our comprehensive suite of services. Astrix experts know first-hand that the PV landscape is evolving and that our clients prefer a strategic IT partner (rather than an IT vendor) who understands and collaborates in solving challenges throughout the RequirementDesignImplementationTesting and Go-live phases of SDLC.  Astrix achieves results using proven methodologies during guided and collaborative sessions led by highly experienced PV pros who keep our client’s needs at the forefront of every decision. Together we determine the optimal implementation strategy and business roadmap, as well as third-party software and hosting choices that represent the best fit for our clients.

For over a quarter century, Astrix has specialized in the scientific and pharmaceutical market providing close support for informatics services to sector-leading companies. Our focus in assisting pharmaceutical and biotech companies, is to enable the information management infrastructure essential to drug R&D, safety, and regulatory compliance today and well into the future.