Embracing Automation to Integrate Medical Information and Safety Operations

April 21, 2023

Contributed Commentary by Beena Wood, ArisGlobal  

April 21, 2023 | Businesses depend on data to inform strategy and measure success across all industries. However, while these companies understand their data’s potential, most haven’t figured out how to leverage it effectively.  

Medical information (MI) teams control a vast and valuable database in the life sciences industry. The data they collect from providers and patients across various channels can:  

  • Advance therapy applications.  
  • Help safety teams identify adverse drug reactions (ADRs) early.   
  • Inform research and development opportunities.  

To maximize this information's value, life sciences organizations must invest in technology that helps unify medical affairs and safety. This enables MI and safety teams to reduce errors, create seamless workflows, and improve cross-domain collaboration, to provide value across the drug development lifecycle.  

The Untapped Potential of Medical Information  

Life sciences organizations have traditionally treated medical affairs as a reactive function. MI teams collect and manage product complaints, log and share adverse reactions with safety teams, and gather information to answer provider or patient queries. Now, they are beginning to realize the value this aggregated information can provide.  

This ever-growing data contains key insights only sometimes apparent to the human eye because of sheer volume. However, MI teams can use advanced technology like artificial intelligence to identify and transmit safety-relevant information faster so that safety teams can use those insights to optimize patient safety outcomes.  

To use advanced technology, MI teams must make their data fully accessible. Unfortunately, many organizations still store their data in silos or data lakes, creating a disconnect and potentially losing critical insights. Integrating medical and safety information facilitates access to all relevant data and empowers automation to streamline shared workflows, like adverse event (AE) intake and reconciliation.   

Enabling Seamless Information Flow Through Automation 

Manual information processes between MI and safety systems often result in cross-functional silos, lost information, lower data quality, and delays. A typical five-step manual process involves:  

  1. A reporter notifying the MI team of an adverse event.   
  2. An MI agent collecting and logging the unstructured report into the MI system. 
  3. The MI agent exporting the report to the safety team.   
  4. A safety team intake associate logging the report separately into the safety system. 
  5. The MI agent manually reconciles both records for future cross-referencing.   

As with any manual protocol, this step-by-step process includes several opportunities for error. For example, the MI agent could accidentally enter the wrong information into the system or forget to reconcile the two reports.   

Automation, on the other hand, removes the human element from MI and safety data entry, reducing the process to three steps: 

  1. A reporter notifies the MI team of an AE through email, chatbot, social media, web portal, or mobile application. 
  2. Advanced automation tools extract relevant case data and automatically populate the fields in a standard inquiry case form. 
  3. The tools automatically transmit the form to the safety system, which can share information with the integrated MI system. Communication between the MI and safety systems facilitates automatic report reconciliation.   

In this process, automation enables a more seamless, tailored flow by reducing the number of stakeholders needed, ensuring each step is fulfilled wholly and accurately, and enabling stakeholders in the field, HCPs, and patients to easily submit reports and access information from anywhere.   

By embracing automation, life sciences organizations ensure all teams have access to the latest information as quickly as possible and can use it to inform strategic objectives.  

Utilizing Open-Architecture Solutions 

To benefit from automated workflows, life sciences organizations must integrate disparate systems. End-to-end, open architecture solutions facilitate communication between multiple platforms with minimal friction or tedious, time-consuming middle steps.  

An open architecture solution acts as a universal plug-in compatible with an organization’s existing systems and streamlines the flow of information to: 

  • Permit rapid reconciliation and verification.  
  • Support quick, complete AE reporting.  
  • Deliver more robust data quality to MI and safety teams to achieve compliance.   

Open architecture solutions empower MI teams to become strategic drivers within their organizations, while safety teams benefit from greater access to data signaling ADRs and identifying risk earlier. Easy data sharing and automated workflows foster better relationships between MI and safety teams, benefiting the entire organization and, most importantly, ensuring next-level patient safety.  

Beena Wood has been building products in the information technology space for over 28 years, with experience across multiple domains. She has led engineering as well as product management teams. She comes from Oracle, where she was in the pharmacovigilance space for over 17 years, leading their Argus Safety Product Management teams, and most recently from Anju Software, leading their Medical Affairs space. She loves building solutions to keep patients safe. She can be reached at bwood@arisglobal.com.