Have you ever wondered who the best pharmacovigilance service provider is? Did you ever stop and think about why PV companies exist and what they’re meant to do? Have you ever been looking for metrics on how to correctly assess PV providers? Did you ask yourself what quality of PV service should mean?

Our new series is going to answer some of those questions and perhaps raise more. More importantly, our ambition with these posts is to start a conversation on redefining what it means to be best in PV services and how quality is measured – or as we’ll show, in fact define these for the first time.

Too many leaders

Anyone who has ever scanned the internet looking for a pharmacovigilance provider probably came across several different firms claiming to be the “leading PV company”, “market leader”, “best-in-class”, even such claims as “number 1 provider”, and similar. To a beady-eyed reader, an obvious question comes to mind: how can multiple companies be the leading PV company or what is implied as being the best pharmacovigilance company?

Surprising just about nobody, there is no ranking of PV service providers and there are of course no objective metrics to define who is best or who is leading the market. If there were any such measurements, why are none of those brazen claims many of our competitors post on their websites unsubstantiated? You can hardly find any justification for these bold statements.

At Tepsivo, we are a group of people who share a pet peeve against random, unsupported, claims. And so, we are introducing a blog series where we hope to attack one of the most blatant ones and break down what has made traditional PV vendors believe they could somehow declare they were the “leading PV provider”.

More importantly, in this series, we outline what we believe the theoretical “number 1 PV vendor” should look like and, especially, what principles it should follow.

Beady-eyed or not, any reader at this point is likely to think this will be a promotional piece with an obvious bias by the authors. The bias is of course acknowledged, but as we’re a group of people with disdain for dishonest claims, you can be assured that the content of this post is based on our sincere beliefs and you will not find any inflated or unjustified statements.

In this series, we are not arguing that Tepsivo is the best pharmacovigilance company in the world. We don’t think such label can ever belong to any one company. Each customer will always have different preferences, and of course, as there are no real measures for anyone to ever make that claim. But what we intend to do is to outline what we strongly believe the core principles should be for anyone trying to be the “best” and establish the right framework in which PV companies should be judged.

Wrong metrics

Sure enough, you can measure PV vendors or CROs by number of employees or by revenue. That may give you the answer to who the largest PV company is or which company invoices the most money.

But that is a very different thing from asking who is best and who provides the highest quality of service. In the world of drug safety providers, high numbers of people and associated costs – in and of itself – are a sign of inefficient and expensive manual labor at the cost of a superior streamlined digital process, not quality. We elaborate on this in the next parts of this series.

As we will also argue later, quality in PV services is 100% legal compliance achieved with the minimum human effort and lowest possible cost, enabling qualified scientists to focus on what really matters: science. So naturally, this is the opposite of a company with a high number of employees charging a lot of money for their time-intensive manual, low value-added, work.

The industry will be in good hands if the best PV company (whatever it may be) adheres to these quality metrics and at the same time becomes the one with highest revenue and number of employees.

That would truly be remarkable. In such a scenario, all the employees deliver added value work without wasting time on mundane repetitive tasks, and they get paid high salaries due to the company’s success. But anyone who knows at least a little about the PV services industry understands that the field is still very far from it.

So, what can we do to change the framework (or rather, establish one)?

What’s the mission?

First and foremost, PV companies need to define their purpose.

Just like the unsubstantiated claims on being the “leading PV company”, and so on, when you browse most PV providers’ websites, you will notice that essentially everyone has the same “mission”.

And it’s exactly the same thing as those claims. Those who don’t allege they have already achieved it, state their mission is to provide “highest quality” service, become “market leading PV company”, “best-in-class”, and so many more similar random statements. Different words, but one meaning, and in each case saying absolutely nothing about the company’s philosophy and what it is actually doing. More than anything else, such vague statements point to the reality that there in fact is no real ethos in the company to speak of.

One might ask, if there’s no mission, why does the company exist?

It should be fairly easy for anyone to uncover. Lack of mission and the blatant inability to define why someone is meant to be the “number one PV provider” or deliver “highest quality” service probably tells you that they are in fact far from it.

Without a clear mission and purpose, there is no hope to ever establish a true framework of quality of service if all that PV companies do is to claim they want to be the best but are unable to define what that should look like. Unless they can characterize their purpose and guiding principles, PV companies can only regurgitate the old standardized and largely misguided practices, preventing innovation.

What’s the way out of this endless loop of stagnation?

What we believe in

At Tepsivo, we have been talking about the concept of value-based healthcare and how it applies to pharmacovigilance for nearly 3 years now, and it is becoming increasingly relevant, especially so in a continuously digitizing world.

The financial size of pharmacovigilance needs to be reduced, heavily.

As a society, we should not be okay with incurring massive costs that one way or another translate into the price of medicines (PV may be a small piece of the puzzle here, but that should in no way justify the frivolous spending; if anything, it should focus our attention to other areas of pharma operations). Most importantly, it should be unacceptable to pay such a high price tag for meaningless activities that are still so dominantly present in the world of PV (whether those can be automated or simply not done at all).

Even if you’re somehow unconcerned about the total cost of PV today, you should be concerned with what has led to it.

Without defined philosophy, PV vendors have standardized processes that weren’t guided by a clear purpose and have become heavily reliant on mundane repetitive tasks with very little effort in progress lest it threaten their low-cost labor/high mark-up based business models. Somewhere along the road, certain standards of “quality” resulting from this entrenched process have been accepted. These standards largely lacked basis in the actual law or guidelines, having been developed by someone’s interpretation and widely accepted through lack of imagination and effort to change things (whether intentionally or through sheer absence of innovative thinking). These “quality” standards, again without backing by the underlying law, have been based on the misguided belief that “more process equals better service”, freely adding one process step over another, meaning more and more people spending their time on mundane repetitive tasks and gradually inflating the total cost of PV.

This needs to change. That is our mission.

Other PV providers may or may not agree with it, but unless they can formulate what their own purpose in the industry is, they’re part of the problem.

Right metrics

Whether it’s the Tepsivo approach or another, what is the defining characteristic of quality? Is there a way we can objectively judge one provider from another? Are there clear criteria for this? Can we define the right metrics?

That is what we develop further in the next parts of this series.