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Pharmacovigilance

Getting the Case Intake Process Right in Your Safety Systems

CATEGORY
Pharmacovigilance

DATE
January 6, 2023

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The Intake process and its corresponding tools have been a point of focus for companies updating their safety systems because the Case Intake (Initial Triage) Workflow phase can take up to 50% of the overall case processing time. Current and new vendors are focusing on incorporating modern technology into their Intake tools to gain efficiency in this portion of the process. Sometimes, however, these modern technologies manifest themselves as features, functionalities, or post-implementation options that can distract, complicate, or unexpectedly impact budgets for new and upgraded safety systems.

While some companies are taking a “Big Bang” approach to evaluating (and replacing) safety systems, many look to maximize their investments by limiting their focus to improving or replacing their Intake tool. In either case, there are some key functionalities that companies should consider when evaluating the next generation of Intake systems:

  • Sources – Adverse events can be received from a variety of sources (e.g., email, fax, social media, company portal). An Intake tool should be able to receive potential cases from any of these sources.
  • Acknowledgement – Once a piece of information is received, it is essential for the tool to have the capability of replying to the sender with an acknowledgment. This can be in the form of an email, E2B acknowledgment, or another format.
  • Accuracy – Once an adverse event report is received from a source, data will be extracted and displayed to the user. An Intake tool should extract most (if not all) of the data with a high degree of accuracy.
  • Translation – Since a report may be generated in a non-English language, the tool should translate it prior to extraction of the case data.
  • User Interface – All tools will look different, but it is important to ensure that it is user-centric, intuitive to navigate, and easily read. It should allow staff to add, update, or delete extracted data when either inaccurate or incomplete. The visual interface should also allow the user to create a new case that was not received by a standard source (e.g., word of mouth).
  • Confidence Score – Tools should display to the user the confidence that it extracted the data accurately. It should clearly call out fields or sections for which it has low confidence so that the user can review the data to either confirm or correct data.
  • Duplicate Check – Post-extraction, it is important to determine whether the potential case is a duplicate or a follow-up to a case previously received. If it is a follow-up, the tool should indicate to the user what data has been updated, added, or deleted. If it is a duplicate, it should point the user to the previous case to confirm the potential duplication.

During the system selection process, it is important to bear in mind two points that will help ensure the best system is selected for the current and future state of the organization:

  • Define clear requirements prior to evaluating any system to avoid the selection bias of considering one system as either a gold standard or the favorite.
  • Evaluate any system’s additional capabilities separately, and in a second phase, after ensuring that required capabilities are both present and in a format that works well for your staff and processes.

Since Case Intake is the first step in the process, it is critical to have an efficient process that extracts all data sent with high accuracy to ensure that all the remaining steps in the case process continue, if not improve, their efficiency.

Why It Matters to You

Because the Case Intake (Initial Triage) Workflow phase can consume up to 50% of the total case processing time, organizations updating their systems need to focus on the Intake process and the accompanying tools. To improve the efficiency of this step of the process, both existing and new vendors are concentrating on integrating cutting-edge technology into their intake solutions. However, these contemporary technologies can occasionally appear as features, functions, or post-implementation alternatives that can be distracting, difficult to plan for, or have unanticipated financial effects on new and upgraded systems.

No matter if your organization is taking the “Big Bang” approach to evaluating (and replacing) safety systems or looking to maximize your investment by limiting the focus to improving or replacing the Intake tool, the key is to ensure the right functionality is available when evaluating the next generation of Intake systems.

In this blog we discussed:

  • Several of the key functionality areas to consider relative to Case Intake.
  • Why this functionality is important.
  • Key points to consider to ensure the best system is selected for the organization.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

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