With the increasing complexity of global regulations, rising costs of pharmacovigilance (PV) systems, shortage of experienced PV professionals, and the exponential increase in the number of adverse events reported annually, pharma and biotechs are turning to PV vendors now more so than ever.

While there is flexibility regarding how to launch a PV program, ranging from outsourcing specific type(s)/volume(s) of work to outsourcing full end-to-end services, a company's decision to outsource is dependent upon various factors, including their program maturity, in-house resources, budget constraints, and ultimate willingness to maintain oversight while relinquishing day-to-day control of activities. Working with a vendor certainly has its advantages, including filling expertise gaps that are critical for a program's success, eliminating costs and time commitments associated with hiring and managing staff, and eliminating expenses related to software investment and maintenance.

'Where should we begin?' is the number one question I get asked by small to mid-sized clients. If you've had a similar question, and without any guidance supporting your assessment, would you look for industry reputation, experience level, quality and compliance history within PV practices, or let a referral guide you? This lens isn't wrong, but it misses the bigger picture that is critical to your success. How you begin your search sets the tone for the activities to follow, ultimately leading to a viable (or not so viable) selection.

I've witnessed strategic, well-thought-out selections leading to a fully functioning partnership, and ones made in a hurry under pressure, leading to costly and time-consuming vendor transfers.

Ultimately, selection must begin with understanding your company's strategic vision. In essence, think of the long game (not short-term needs) to propel your decision making, selecting a partner that will be your strategic ally for the long haul.

What does that look like? Here are strategic considerations and examples to avoid costly and timely mistakes.

Begin with Strategy - It's About the Long Game

Leaders in charge of the vendor selection need to consider a vendor not just for today , but one that will fit their long-term strategy years from now. Consider the following: Country and Regional Presence:
  • Where will your product be marketed? In what countries? In what regions?
  • Ideally, you're likely to expand your market in multiple countries, requiring regional expertise to navigate PV regulations and guidelines. Assess whether the vendor operates in the regions you're targeting across the entire development lifecycle so they can meet your program's evolving needs.
Ability to Supplement Your In-House Skill Gaps:
  • Take the time to identify your in-house PV expertise gaps, using those gaps as critical selection criteria to supplement your team's skillsets.
Oversight Compatibility:
  • Consider the ability of your team to oversee the work performed by the vendor; this relationship is critical to success. A vendor point of contact needs to be appointed to ensure your vendor is informed of required practices and upcoming project changes, monitors and provides oversight of performance, and provides feedback to ensure strong, aligned delivery. Too often a lack of oversight, even with the best service providers, can result in communication gaps and failure of the outsourcing initiative.
Ability to Function Across the Entire Development Lifecycle:
  • What phase are you in now and what milestones are ahead? Use this information to guide the work you're looking to fill now and, in the future, to select a vendor that can evolve with your program's needs to prevent burdensome vendor changes. For example, if you are in early clinical development and selecting a vendor that is restricted to clinical work, consider the costs and time required to move case reports into one safety database when the product obtains postmarketing approval.
  • Assess whether the vendor provides multiple services to limit the number of contracted vendors, saving unforeseen costs associated with multiple contracts, invoices, and oversight.

What It Means to Be a Vendor Partner

Once the strategic vision is finalized and you've assessed your in-house PV expertise gaps, that assessment should be used to your advantage, propelling your search for a true partner. What do I mean by a true partner? A vendor partner:
  • Provides thought leadership: keeps you aware of industry changes to support your strategic planning.
  • Is transparent: establishes a strong reporting mechanism for ease of oversight, and provides an efficient meeting governance structure for essential knowledge sharing, planning, and proactivity.
  • Refrains from being a transactional vendor: adopts a clear and communicative approach, provides suggestions for improvement, assesses efficiency and recommends process changes, where needed, to save money, time, and promote quality.
If you're unfamiliar with the ins-and-outs of PV, you're not alone. You don't know what you don't know, so be critical about your vendor's knowledge and selection criteria so that you're not facing challenges and unknowns later. As you assess your current and future needs, be intentional about where you're falling short, then carefully select a vendor who has those skills, asking for specific evidence on how they've worked with clients. This lens will ensure you are saying 'yes' to the right vendor.   Contact us to learn more about how PLG successfully supports clients.  

Contact us
← Back to all