Drug Safety

Don’t get lost in the jungle of drug safety vendors

The significant increase in workload of drug safety employees has triggered a virtual explosion of new digital systems for drug safety and pharmacovigilance. With a vendor agnostic approach, NNIT can help you navigate safely and select the best solution for your specific needs.

Across the life sciences industry, pharmacovigilance (PV) inboxes are groaning under a steadily growing volume of adverse event reports, greatly adding to the workload of the drug safety employees. Fortunately, there is no shortage of digital systems that can potentially make the PV processes much more manageable and efficient. However, this variety of choice brings its own form of complexity.

At NNIT, we have guided life sciences through digital transformation for decades. In recent years, we have seen a significantly increased focus on drug safety and pharmacovigilance, and the market for solutions towards this area is much more diverse than for instance regulatory affairs or clinical.

As many pharma companies have discovered, finding, and implementing the right PV system can be challenging. This hurdle can be overcome with the help of a trusted advisor like NNIT, who has both the industry insights and technical expertise to guide you safely both before and after go-live.

In-house or outsourced

Some pharma companies choose to outsource most of their PV activities to a contract research organization (CRO) or similar third-party partner. But a significant portion choose to manage PV themselves because they want to maintain the full overview and control, and ensure that drug safety serves as a business accelerator.

With the right mindset and tools, a life sciences organization can transform drug safety from a cost center to a value-creating part of the business. The insights from PV data can be used to drive significant improvements in business outcomes. But regardless of whether this task is outsourced or kept in-house, you need a strong digital data foundation to do it.

The selection process

When working with life sciences clients to identify the right PV solution, NNIT recommends the following approach.

Define criteria and needs based on company-specific processes, considering time constraints and whether to retain existing processes or adopt new ones.

Align with stakeholders across the R&D organization and gather insights from companies similar to your organization who have recently implemented PV systems. Use this input to select 3-5 vendors based on criteria like references, compatibility, cost, licensing structure, and technological advancements.

Assess the complexity of migrating from your current system, focusing on data formats and best practices to ensure a smooth transition. Consider what you will do with your legacy data and your non E2B data, and whether the CIOMS formats are the same in the current system and in the new.

Conduct guided demos with short-listed vendors, involving cross-functional teams to assess the solution's relevance and its alignment with the company’s strategic digital roadmap. It is crucial that both IT and line-of-business are included in this step.

Test 1-2 short-listed systems in a sandbox environment to gain first-hand experiences with the systems. Then evaluate based on specific requirements and identify necessary updates.

Decide on the most suitable PV solution based on the evaluations and tests conducted.

Build a solid contractual foundation with the vendors of the current solution (if relevant) as well as the vendor of the new solution. For example, it might be relevant to include a milestone penalty due to critical cutoff date.

Ensure that the needed resources and skills are available, spanning from project management, validation/QA, PV SMEs, migration experts, integration specialist. It is especially important to have your own qualified project manager with oversight of the full project from the pharma company perspective, as the vendor project manager’s focus on the project is from the vendor side.

Think beyond go-live

The more deliberate and informed the selection process is, the better equipped you are to choose a system that meets your specific needs. It is especially important to consider the requirements of all stakeholders and relevant processes, not just in the immediate future, but also in a long-term perspective. Often, the vendor focus will be on getting the solution to a successful go-live, but significant work takes place after implementation and go-live.

A thorough selection process pays great dividends in all matters. We have seen several implementation projects either being prolonged significantly or expand in scope and uncertainty if the prework has not been addressed properly. It is important to stay on track and be true to the choices you made during selection. This is where we at NNIT have a lot of experience spotting the places where the client organization might not fully realize the long-term implications of specific actions.

Don’t underestimate the human factor

Taking the time to run a comprehensive selection process might sound obvious and straightforward, but it can be surprisingly difficult to carry out in practice. The main challenge is that such a process requires input and attention from key employees and subject matter experts (SME’s) who are typically extremely busy.

Companies often underestimate their own ability to get fully involved in the process while keeping day-to-day operations running smoothly. You must either reduce the workload of your SME’s or bring in additional resources. It takes a significant amount of organizational bandwidth that can be very difficult to estimate up front without an experienced partner.

Change management, organizational insights and integration to other systems are just a few pieces of the puzzle. It requires knowledge and experience to make it all fit together, but there can be no doubt that a well-functioning PV system is vital to the digital transformation of drug safety.

6 reasons to choose NNIT as your partner for PV system selection

As independent advisory consultancy with a vendor-agnostic approach, NNIT can maintain the necessary focus on your specific needs.

In addition to deep knowledge about the life sciences industry and the availability of different PV solutions, NNIT also has insights into the internal quality and control processes for most vendors.

Understanding the different solutions on the market gives the opportunity to match the right solutions with the specific PV organizations. Understanding both current solution and the source system is key to success.

Get the necessary manpower and assistance for consultants with expert insights in PV and drug safety operations.

The right PV solution is essential to enable automation and use of AI across the entire organization. At NNIT, we have the skills and experience to see the full picture.

At NNIT, we can cover the entire process, from early advisory to vendor selection, migration, implementation and beyond. We are your guarantee for a viable, long-term, and future-proof investment.

Contact us

Interested in knowing more about how NNIT can help with selecting and implementing the right PV solution? Feel free to contact us with any questions.

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