Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite right, that you have to work awfully hard just to stay in the same place, and that no one is responding to your cries for help, but you don't realize how deeply in trouble you are, until it's too late. This same advice may also apply to working with subpar pharmacovigilance (PV) vendors. When clients realize that their PV activities are not running smoothly, that they are doing the heavy-lifting and not making any progress, while their requests are not being responded to, perhaps the situation requires a full-blown rescue.
Within our industry, a rescue refers to transferring the responsibilities for an active program from one company to another. It's similar to repainting the exterior of a plane while in flight. There are risks, costs, and duplication of effort until the handoff is completed, and in the meantime, someone must continue to focus on flying the plane. For these reasons, understandably, clients are reticent to move forward even when all the signs indicate a rescue is needed. But a rescue is necessary nonetheless.
Know the signs
Similarly to the riptide example, assessing the signs of danger can be difficult.
- Are things going as expected?
- Once complaints have been voiced, is the PV vendor doing the work to get the project back on track?
- When feedback is provided, is the response time minimal?
If you've answered in the negative to the above questions, all the danger signs are present. Being honest with yourself about these danger signs can help inform you of the next steps to be taken. While I highly recommend sharing your brutally honest feedback with your current PV vendor, if their response is not going to drastically improve the project's situation, it's better to cut your losses and run now rather than sacrifice the program's success.
Don't make the same mistake twice
One of the most challenging, yet still essential, aspects of the rescue process is examining how the client may have contributed to the breakdown of this partnership. Were expectations provided in writing and clearly understood? Were process changes supplied in writing with supporting explanation? Are timelines reasonable and communication open? There is no excuse for an underperforming PV team, but to avoid history repeating itself, it is helpful for clients to start this analysis by reflecting on these tough questions. Next, it's helpful to make a list of any unmet and unusual program needs. For example, should you consider having a full-time dedicated project manager because daily touch-base meetings are a must? If you frequently require quick changes to the database or ad hoc medical consultations for process adjustments, would you consider adding a line item to your budget for ad hoc requests to eliminate the need to wait for change order approval? Do you have preferences regarding the countries where your assigned team is located, and how you should clearly present that? Do you have future plans that should be revealed at the outset of the PV partnership, such as having certain members of the assigned PV team attend meetings at your corporate office or even have the team work from your corporate office? Just as every program is unique, so are the needs of each client, so being aware and communicating those needs up front will decrease future barriers.
Selection time
There are no shortcuts to finding the best fit for your new PV vendor, and often the process reveals very few differences among the contenders. To narrow the field, here are some suggested areas to dig into:
- Transition Plan template and timelines- ensuring that the new team is well-versed in riptide rescues
- Options- your program needs a bespoke solution, which will only be possible if the vendor has myriad options to offer
- Responsiveness test- the Sales team might be super responsive, but to test the operational folks, send a question that only the PV team would be able to answer and see how long it takes to get what you need
- Ask for examples- if your pain point is communication, ask an ambiguous question and see whether the prospective vendor shoots back a clarifying question or really tries to answer thoroughly. If your pain point is quality, ask for a sample narrative. If your pain point is compliance, request the submission compliance data for the past three years.
Taking a serious look at the unusual needs for your project and then digging deeper into the areas where more attention is required for your clinical trial or marketed program will help you find that perfect PV match. And even though rescuing your project feels daunting initially, the success of your program depends on it!
TAGS: Pharmacovigilance
