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Blogs: How to Select an Automated Drug Safety Platform in Three Steps

Your team’s workload grows by the day. The volume of Safety cases you’re managing increases significantly every year. All the same, the internal pressure to save the organization time and money is mounting. Automation has never been more pivotal to the success of Safety teams like yours.   

It’s not enough to have a dedicated drug safety solution. The IDC estimates case volumes are growing 30-50% each year, driven by multiple factors, including the rise of new digital reporting channels and more treatments for complex diseases. In response to this pressure, more and more organizations are turning to automation to manage growing case volumes while driving operational and financial efficiency. Automation provides the path forward. 

The benefits of automation go beyond increased efficiency, providing additional benefits like increased data quality, greater process consistency, and the opportunity to shift resources toward higher value initiatives. From robotic process automation (RPA) to artificial intelligence (AI) and machine learning (ML), automation eliminates repetitive tasks from employees’ workloads and empowers employees to make better decisions faster via AI-powered insights. Automation provides organizations with the potential to transform Safety from a cost center to a strategic pillar of innovation.  

If you’re looking to upgrade your Safety system to one with robust automation capabilities, you’re not alone: leading biopharmas are aggressively investing in case management automation, and 74% of organizations across the life sciences industry say that the opportunity to have automated safety signal detection and risk management would be beneficial or even game-changing. Even the world’s biggest regulators are adopting automation technology. As you evaluate automated Safety solutions, here are three major elements you should consider.  

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1. Choose the right drug safety software and technology partner 

Some companies are experts in life sciences and understand drug safety operations inside and out. Others are technology experts, nimbly crafting and training best-in-class intelligent automation. However, very few are both.  

Safety operations and case management is highly specialized. The entire system must be carefully built to manage the distinct needs of a Safety team, and the automation embedded into best practice workflows for compliant case management. In some instances, a software provider may start with an established Safety solution and later add automation capabilities, but fail to integrate the two. If the automation functionality is not built within the platform but rather tacked on as a feature, the “solution” becomes cumbersome and ill-equipped to handle industry-specific processes, potentially requiring a human touch to move from process to process. Teams without end-to-end automation miss out on the additional gains that come from automating tasks that are deeper within the case management workflows.  

The ideal Safety technology vendor is one with a wealth of safety industry experience and a track record of expertise and in-house investment in automation technology. Both are critical to building a reliably automated Safety system. Companies without Safety experience lack an intimate understanding of complex and nuanced Safety workflows – something these vendors may underestimate or rely on your organization to train them on. At the same time, you’ll want to seek out in-house automation expertise, because it’s required to identify the right tasks to automate, to choose the technology best suited to handle those tasks, and to deliver that automation seamlessly in a Safety solution.  

Here are a few signs that the technology vendor you’re investigating is industry-trusted with reliable automation capabilities:  

  • Drug Safety and pharmacovigilance expertise 
  • In-house automation expertise 
  • Robust and ongoing investment in automation technology  
  • Natively integrated approach to Safety automation 
  • Roster of customers using automation in-production, including CROs, sponsors, and regulatory bodies alike 

2. Ensure the automation capabilities are transparent and pre-validated by those with Safety expertise.  

Safety is too important to trust unexplained functionality. The Safety solution you choose should allow your organization to understand, and explain to an auditor, what steps the automated system performed and why. This means the system is transparent and validate-able, not a mysterious “black box” the vendor asks you to trust.  

The best Safety solutions will come with intelligent automation that has been pre-trained with an incredibly extensive set of data and rigorous training exercises modeled after what is encountered in real-life environments. Access to this data in quantities large enough to successfully train these systems will only be available to technology vendors with a long, rich history in the Safety industry. 

With access to enormous data sets like these, it’s possible to pre-validate an automated Safety system. In this case, pre-validated means the intelligent system has processed and learned from enough data that it is ready for near immediate, out-of-the-box use by any organization following standard, compliant procedures.  

Conversely, some vendors work on the refuted assumption that every automation deployment requires a from-scratch validation exercise. These vendors impose expensive consulting engagements for training and validation during implementation. This consultant is essentially in place to quality check the automated system, incurring additional, ongoing costs. These systems are always reliant on the consultant and lock organizations into expensive third-party agreements.  

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On the other hand, some software vendors may claim their solutions have been validated while emphasizing a need to train the automation using a customer’s bespoke data – another avoidable cost. These systems work, but they must be calibrated to each individual organization’s datasets and workflows. This significantly elongates the implementation process, costing the organization valuable time and resources.  

The ideal Safety solutions offer pre-validation, meaning the automation technology is intelligent and reliable enough to produce accurate and trustworthy results for any life science organization, immediately upon implementation. As previously stated, these systems undergo AI/ML model training during development, before the automation ever hits the market, saving time and money on behalf of the customer. 

This is why it’s critical to choose the right industry-trusted technology partner. In order to develop a solution that is intelligent and sophisticated enough to be pre-validated, that vendor needs access to an enormous repository of historical Safety data. The more data points artificial intelligence learns from, the better trained and more reliable it will be in practice. This is the same reason you should seek a solution that was developed with input from the life sciences industry. Without Safety expertise, a technology vendor cannot train its AI to handle Safety cases appropriately, with industry-standard practices and compliance. Technology providers with the most field deployments, real data, and proven experience are best equipped to identify the functions ripe for automation, the right automation tool to apply for best results.   

3. Choose a true end-to-end solution 

Many existing solutions promise full-scope automation but deliver only on the ability to automate select tasks like data intake. While these worthwhile use cases can save time and effort, it’s only the tip of the automation iceberg.   

For optimal return on investment and true efficiency gains, seek a solution that has mature, end-to-end automation capabilities. These platforms apply automation deep within Safety workflows, rather than only to a few peripheral tasks to the overall case management. An end-to-end approach enables Safety teams to allow the system to automatically run integrated workflows, greatly accelerating case processing speed. End-to-end automation can even enable functionality like touchless case processing of non-severe adverse events, allowing employees to oversee the process, but focus much of their time and attention on nuanced aspects of Safety that benefit from or require human judgment.  

When Safety systems are equipped with end-to-end automation, full efficiency gains are realized. The automation goes beyond deterministic functionality and disconnected automation tools to alleviate employees’ workload and free their time for strategic, complex problem-solving. By choosing a solution that automates workflows across the Safety spectrum, from intake to submission and on to signal detection and risk management, you’ll be arming your organization with a powerful tool that provides efficiency beyond the sum of the time saved from automating individual tasks.  

Take Your Safety Operations to the Next Level with a Proven and Reliable System 

While it’s clear that automation is the way forward for Safety teams, choosing the right system can be daunting. Many technology vendors promise best-of-breed functionality but miss the mark when it comes to true capability.  

Organizations looking to invest in a next-generation Safety system should seek a technology vendor with proven industry knowledge that can deliver a pre-validated solution with true end-to-end automation. These are the more important factors to evaluate when vetting potential Safety solutions’ automation capabilities.  

Talk to us to learn more about how automation can benefit your Safety team. 

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