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Think Tank

How Technology is Enabling Advancements in the Assessment of Patient Safety

Pharmacovigilance (PV) activities must be carefully planned from the outset of the drug development process. A comprehensive PV strategy, requires a depth of understanding not only in terms of the complex and rapidly evolving safety landscape, but also in new tools and approaches that may significantly streamline and simplify workflows, increase the capacity of your team, lower your cost to deliver safety services and most importantly, helping you differentiate and maximize your products value in the marketplace.

Below are a few process automation solutions UBC has implemented within our PV operations which we believe offer our clients a best-in-class experience as a provider of comprehensive global pharmacovigilance services:

  • AI-Based Case Intake Automation – We have automated our workflows and leveraged cognitive technologies, such as optical and intelligent character recognition (OCR/ICR) and natural language processing (NLP), combined with our library of safety specific user interfaces to facilitate rapid case intake and data entry.
  • Electronic Reportable Event Forms (eRefs) – We developed electronic reportable event forms (eREFs) to further streamline the case intake and data entry process. This solution is ideal for a high-volume of cases due to web-based data entry forms that replace paper forms.
  • AI-Based Literature Review – Leveraging our DistillerSR platform, we can better focus on the content of the documents under review without separately managing work in disparate spreadsheets. The platform utilizes AI and advanced machine learning algorithms to automatically prioritize documents and call out keywords requiring attention providing error reduction with confidence.

Process innovations are complemented with UBC’s robust reporting platform capabilities, reducing turn-around time for custom-line listings through:

  • Advanced Reporting Solutions – Streamline the process of generating validated and compliant database outputs by removing the need for custom report development and validation.
  • Standard Analytics Dashboards – Access key program analytics through a cloud-based, self-service portal.

Pharmaceutical and biotechnology companies benefit from working with external partners to manage PV activities. The breadth and scope of required services can depend on the mix of investigational and marketed products, the size of the company, and their comfort with outsourcing safety. Organizations realize a variety of benefits when collaborating with an experienced and innovative technology partner for safety services. Contact UBC today to connect with a member of our industry-leading PV Team.

Additional Resources

Are you PV ready? Evaluate your program using our complimentary Safety Readiness Checklist here and ensure the proper oversight is in place for all of your safety reporting.