Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

Previously, we outlined the critical components to be considered when starting a clinical trial program (Safety Services: A Critical Component of Clinical Trials). In this second installment we'll be focusing on areas to help choose the right vendor for post-marketing pharmacovigilance (PMPV) services. As the pivotal trial of the investigational phase gets underway, it's time to consider setting PV plans in place to submit the marketing authorization holder (MAH) application.

Keep Your PV Options Open

It's important to know which PV services are required versus optional for this next hurdle. The type of application as well as the regions where the MAH application is being submitted will create this framework of requirements. A regulatory consultant can guide you through this process successfully. One vital question to ask each PV vendor candidate centers on how much freedom of choice the client will have. Can services be optional? Can the service ramp up and down depending on the client's needs at different times? To avoid paying for unnecessary services, beware of PV vendors offering only a full PV package without exception. Not knowing the future of the product means keeping all of the options open to you, but you sure don't want to pay for unused services.

Often clients also need additional assistance before the product launch. Some PV groups are willing to take on the role of the MAH for a client prior to and after launch, which allows clients to gain approval before they establish their required internal resources. Providing this bridge for clients who are still building their internal expertise is one more way that PV teams can provide clients with freedom.

Business Partners in the Mix

By this stage, many sponsors have business partners added into the mix, and that opens up several areas to think about. Of primary importance is submissions. Because these affiliates typically fulfill their own regulatory reporting needs, the partners must be provided with an approved, submission-ready report in the agreed upon timelines. This means that your PV vendor needs to consider distribution to business partners in the same way they consider submission to health authorities, including monitoring compliance, tracking the type of reports, and the date sent to the partner within an auditable system. Second, there are the agreements that bind clients with their partners, including Safety Data Exchange Agreements and PV Agreements. When multiple partners are involved, having a PV team that can update and maintain these agreements becomes very helpful. There are several other areas to consider regarding business partners, such as whether a true exchange of data is needed and whether the business partner will have access to your PV vendor, sending queries for follow-up information and data clarifications. Each of these may affect the costs invoiced by PV, so a proactive discussion can help avoid surprises.

Another factor to consider is the reach of the network of Local Persons for Pharmacovigilance. This may not be a consideration if your product is only being marketed in the USA. However, for global MAHs, this becomes a real concern requiring clients to engage multiple vendors to cover all active regions for a product. Selecting a vendor with a broad reach allows clients freedom regarding the number of vendors to engage for submissions.

Tips for Exploring Vendors

A very simple question that can reveal a lot about a PV group is to ask them to explain their ‘product add' process. Clients frequently add new products to their portfolio, either through acquisition or clinical investigation, which then requires all services to function seamlessly together for successful integration of the new product. Having a checklist of all the people to be notified, documents to be updated, database changes, and the timelines for each is a must. If the answer to this question does not consider every task within PV, there may be a gap in their PV system.

A more complex area to investigate is the signal detection process in place. Ideally, a signal surveillance program should be able to start during the clinical phase and flow through the post-marketing phase, gathering more data and confidence in the product's safety profile. Signal detection is not just a means of finding those areas of concern but also a way to rule out adverse effects. A robust process involves layers when a potential signal is identified, confirmed, validated, and outlines the recommendations for actions. Without a strong set of procedures in place, your program becomes open to risk.

Selecting a vendor for post-marketing PV work can be as simple as asking to understand all of your options. You may not need every service available at the time of product launch, but when you do need it, you'll be happy to have a vendor who can support you.

Author

Laura Hopper

President, Pharmacovigilance