Data is the lifeblood of businesses today. Data informs strategy and measures success across all industries. While some companies now understand its potential, most are still determining how best to leverage their internal data.
Medical Information (MI) teams hold an enormous – and valuable – database. As MI teams collect data from patients and providers across a variety of channels, they act as stewards of that database. The amount of information held here has experienced massive growth in the last few years with a notable volume increase of both inquires and engagement channels. This data holds insights that can inform research and development (R&D) opportunities, advance therapy applications, and help Safety teams flag adverse drug reactions (ADRs) early.
To capitalize on this data, organizations must invest in new technology that will aggregate data across MI and Safety teams automatically. Data aggregation provides the full picture by combining the information held by Medical Information and pharmacovigilance departments to make both teams more efficient by reducing errors and streamlining important follow-up.
Some pioneering organizations have already integrated their MI and Safety solutions in this way. Integrating the software allows these two teams to work together more seamlessly and encourages greater collaboration. The result? More empowered, strategic MI teams, faster identification of adverse events, and increased data quality.
The Untapped Potential of Medical Information
Medical Affairs has traditionally been a reactionary function within life science organizations. MI teams take in product complaints, log and share adverse reactions with Safety teams, and collect information to answer queries that come in from providers or patients. After years of gathering such information, MI teams are beginning to recognize the potential value of their data.
Within these massive databases lie key insights that may not be readily apparent to the human eye due to the sheer amount of information. However, when analyzed using advanced technology like artificial intelligence, patterns and signals can be found within this data. In some cases, these insights can be used to advance additional business goals, whether that be finding a new off-label use for an existing drug or catching a potential ADR before it affects other patients.
To deploy advanced analysis techniques on this data, it must first be structured in such a way that it is fully accessible. Today, many organizations have data stored in silos or in data lakes that make it difficult to assess. Even so, Medical Affairs employees unanimously report that what is expected of their role has shifted from that of a support function to that of a strategic driver.
This is where the technology comes into play. Integrating the organization’s Medical Information and Safety systems provides greater access to all relevant data, while automation capabilities that streamline shared workflows – like AE intake and reconciliation – enable greater efficiency and data integrity.
The Case for Automation
Automating case intake and reconciliation is one of the primary benefits of integrating the MI and Safety solutions. On the surface, it’s a time-saver, but the benefits go beyond that. Automating this process provides an added layer of security, ensuring these cases are processed accurately and completely, and that no requisite follow-up is forgotten or overlooked.
Consider the five-step manual process:
- A reporter notifies the MI team of an adverse event. At one time, this primarily happened by phone or faxed handwritten form, but today it could come through a web portal, chatbot, email, or social media.
- A MI agent collects the unstructured narrative report and logs it into the MI system.
- A MI agent generates an E2B file so the report can be exported to the pharmacovigilance team.
- An intake associate on the Safety team receives the report and logs the information – separately – into the Safety system.
- Back where the intake began, a MI Agent manually reconciles the records for cross-referencing in the future.
As with any manual protocol, this process is riddled with opportunities for error. For example, the MI Agent could accidentally enter the wrong information into the system or forget to reconcile the two records. The process is labor-intensive and takes up much of these agents’ time.
Now consider automating this same process:
- A Reporter notifies the MI team of an adverse event via email, web portal, chatbot, or social media.
- Advanced automation tools extract relevant case data and automatically populate the fields in a standard inquiry case form.
- The form is automatically transmitted to the Safety system, which can share information with the integrated Medical Information system. Because the systems can freely communicate, the reports are automatically reconciled.
Introducing automation reduces error by removing the human element, reducing the number of stakeholders playing a role in each case, and ensuring no piece of the process is forgotten or neglected. By taking these steps to ensure the integrity of their data, life science organizations can feel confident that their Medical Information and pharmacovigilance teams are compliant and that any insights pulled from the data these teams hold are worth investigating further.
Integrating Medical Information and Safety Elevates the Workflows of Both Teams
The benefits of automating workflows as described here are not achievable without fully integrated systems; but that doesn’t mean the organization is pigeonholed into using a single technology partner. Open-architecture solutions have made it easier to integrate disparate systems, allowing two different platforms to communicate with one another. That allows information like intake reports to be shared between these systems without manual conversion to compatible file types or other inconvenient middle steps.
By sharing data, both the Medical Information team and the Safety team benefit. MI teams, which need to work with Safety teams more now than at any time before, are empowered to become a strategic driver within the organization, while Safety teams benefit from greater access to data that could signal ADRs, bring attention to risk earlier, and improve patient safety.
Manual processes are less productive and are subject to lost information, lower data quality, and delays. Automating these processes ensures greater data quality, consistency, and compliance; but it also goes a step further. Integrating these systems fosters better workflows and relationships between these two teams and is the first step toward creating a symbiotic relationship between Medical Affairs and Safety that will benefit the entire organization.