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Blog: Safety and Automation in the Post COVID-19 World

It’s hard to think about COVID-19 and vaccine production, without reflecting on the speed, safety, and risks involved in the entire process. With so much at stake, clinical trials faced immense pressure to produce new vaccines quickly while prioritizing essential safety and surveillance requirements. While a faster time-to-market is an exceptional feat, workload and case volumes increased exponentially while there was a decrease in budgets across the industry due to the financial impact of COVID-19. Let’s take a closer look at how the pharmaceutical industry will change as a result of the rapid vaccine production that is changing the way we live.

Collecting Safety Data

Previously, vaccine production took anywhere from 7-15 years, with several years required for each phase of vaccine development. With the swift creation and approval of multiple vaccines in less than a year, there are a few critical changes that will impact all of the industry. First and foremost, safety data collected through all clinical trials is now more important than ever before. While safety data has always been collected during clinical trials, remote and parallel clinical trials contract the time to market. Collecting safety information during these trials now becomes critical to meet the aggressive time frames the industry has seen during this pandemic. By demonstrating this can be done, the contraction from interesting compound to authorized therapeutic is very likely to change time-to-market expectations for all drugs. Speed to market, with no compromise in safety and drug surveillance, needs to be the norm. Without this, compounds that may be found of lower safety may erode confidence in all drugs brought to market in this new way.

Predicting Adverse Events

Second, the ability to see signals in data is of critical importance since adverse events can be complex. The ability to collect and analyze signals to find safety concerns leads to a proactive instead of reactive approach to surveillance and pharmacovigilance. The earlier concerns can be found, the greater the opportunity to reduce the risk to patients on new therapy. With increased automation removing mundane process tasks, teams can spend valuable time on analysis. This increases efficiency and significant strong signals can be analyzed for concerns by resources in your safety or PV teams to answer the most important question sooner: Is this drug safe? One way this can be accomplished is with LifeSphere Signal and Risk Management, software with deep safety intelligence, delivered in real-time.

The recent vaccine production has also placed an emphasis on the reduction of manual processes with a renewed focus on decision making. The realization that reducing time does not mean reducing safety, allows companies to become more streamlined in their approach and more efficient to produce positive results. With team members completing parallel tasks, the goal is to turn safety from a reactive to a proactive model. Early detection improves decision making and drugs can be delivered with more safety information than ever before. Understanding a drug’s safety profile and understanding the risks leads to safer drugs. The ability to have cognitive computing involved in decision making has also been a game changer. Now life sciences professionals can make informed decisions based on accurate data faster than ever.

Getting Real Results

With ArisGlobal’s LifeSphere Intake and Triage, the only case intake solution with production-ready automation, teams can get real results right away. Developed and tested with industry leaders, including the US FDA, LifeSphere Intake and Triage automates case intake to bring deep efficiency gains and scalability to case processing. It eliminates 90% of traditional data entry efforts and simplifies safety case processing, leading to immediate and sustained time and cost savings as well. Advanced machine learning (ML) means that system effectiveness improves as more data is processed.  With the extraction of potential adverse event data from multiple structured and unstructured sources, including email, fax, literature, electronic gateways and mobile applications like LifeSphere Reporter, it is the industry-tested solution you need.

Learn more on LifeSphere Intake and Triage.

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