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Blog: Why Now Is the Right Time to Invest in Your First Drug Safety System

Small and emerging biopharma like yours face a crucial question – should you outsource your drug safety system, or bring it in-house?

A New Opportunity in Safety

Not owning your own drug safety system, and instead outsourcing ownership to a CRO or other service provider, can lead to several common issues.

A lack of transparency can create a ‘black box’ around case management performance, as access to your data is controlled by your partner. Without choice around what automation your drug safety system leverages, you can miss out on potential efficiency gains. Considering the growing volume of cases documented year-over-year, lack of efficiency and insight into your automation can be detrimental as you prepare for growth over time. And if you decide to switch providers now or later, uncoupling your safety database can cause costly and disruptive data migrations.

On the other hand, while owning your own safety drug system can provide key benefits – including greater data control and transparency, flexibility in choosing automation, and ease in switching partners as needed – the length and complexity of on-premises deployments have often made bringing drug safety systems in-house too costly for small and emerging firms to justify.

Enter cloud technology. 

The advent of cloud-based drug safety systems has significantly decreased deployment time and IT overhead. This has led to an exciting new opportunity for small and emerging firms to bring their drug safety systems in-house in a simple and affordable way for greater transparency, flexibility, and control as you continue partnering with case management service providers.

Small and emerging firms are taking advantage of these modern, cloud-based drug safety systems to drive agility, efficiency, and competitive advantage.

The Advantages of Drug Safety System Ownership

Owning your own drug safety system sets firms like yours up for success in three critical ways.

First, it provides increased data control. Bringing ownership of safety data in-house helps you establish a single, easy-to-access source of truth. This can help you ensure audit readiness with greater rapid visibility into cases, workflows, and compliance timelines. It also makes it easier to oversee partners, which is essential, especially as you change partners and scale your operations over time to best suit your needs.

Second, it enables greater operational efficiency. Automation is key to lean and scalable operations, and – especially as a smaller firm with traditionally tighter budgets and resources – owning your drug safety system gives you the freedom to implement the automation you see fit, to maximize case management efficiency, and scale economically as caseloads increase by using automation in place of more labor. You gain the ability to choose the best automation on the market that works for you.

And then finally, it maximizes your partner flexibility. Forcing yourself to be locked into a single provider due to fear of switching costs keeps you from using the best partners to suit your unique business needs. By owning your own drug safety system, however, you can readily provide and remove access to your environment to partners, to ensure your ecosystem is tailored to your needs over time.

Where Do You Go from Here?

So, by now you’ve decided that a business case exists for your own drug safety system – but how do you get started, and what should you be looking for?

In our Safety Guide for Small and Emerging Biopharma, we continue this discussion, outlining key items small and emerging firms like yours should keep in mind when looking for your first drug safety system and how to ensure success as you continue growing your operations.