A few months ago, I had an insightful conversation with a PV leader who asked about the current opportunities within PV technology for a CRO. Like most, my initial response was a generic suggestion—embrace AI, automate processes, and so on. However, this post isn’t about the usual recommendations you hear everywhere.

Now that I’ve spent considerable time in the pharmacovigilance domain, I’ve encountered specific bottlenecks that persist in PV technology companies. Here are some of the key challenges I observed that PV technology companies can address to build better products and make people’s lives easier:

Complex QA Processes

Whenever people suggest a change to simplify workflows, QA often responds with, “Oh! We are the ones who face audits and inspections. This is how it should be done.” It appears to me that QAs don’t challenge the status quo and prefer traditional methods. These complex processes delay progress. Tasks that should be completed in hours often take days. Processes should not hinder the adoption of change.

“There is a way to do it better. Find it.” — Thomas Edison

Outdated or Overly Complex Tech Stacks

You need four servers to host a safety system and an additional four for disaster recovery. That is the server requirement for hosting a medium-sized pharma company with 50 concurrent users using one of the best safety systems on the market. Does it really need to be this complex? Another SaaS application I had the privilege of working on used so many technology layers that setting up an instance took more than a week. Shouldn’t automated provisioning and multi-tenancy be part of a SaaS safety system?

“Everything is designed. But few things are designed well.” — Brian Reed

The “Workaround” Culture

For many issues and bugs, product companies provide workarounds. An IT sage once told me, “There is nothing more permanent than a temporary fix.” Once a workaround exists, fixing or refining that feature takes a back seat because there are 100 other items in the backlog. Take time to refine existing features. Just because E2B profiles can be customized doesn’t mean you should ignore bugs in the out-of-the-box profile code.

“Be passionate about solving the problem, not proving your solution.” — Nathan Furr

Overpromising by Top Management and Sales

In drug safety conferences, some so-called IT leaders present slides claiming their safety systems use the latest futuristic technology, even though they are nowhere near implementing such features in their products. Just because a technology exists doesn’t mean it needs to be included in your product. The same goes for features that are in your roadmap but not yet in your product. When you exaggerate, lie, or omit the truth, developers end up working overtime in India because you made unrealistic promises to clients.

“Care enough to create value for customers. If you get that part right, selling is easy.” — Anthony Iannarino

Have you also faced similar challenges or any others? Let me know your thoughts in the comments.

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