Today Pharmacovigilance has gone through what some would call a revolution. That’s due in large part due to the technology that vendors are implementing within their safety systems.

Many companies are assessing their case intake system. We at Astrix are assisting many companies with their projects and whether it’s helping them with their RFP’s, or with their implementations, the most common questions that we hear when assisting companies are:

• What are the features and functionalities that we should have or expect the tool to be able to do?
• How is it going to make my processes more efficient?

We all know case intake/triage is one of the most manual and time-consuming parts of the process. We at Astrix have had clients estimate that case intake is as high as 50% of the total time spent on a case.

One of the issues that companies have today, even with all the time they are spending on case intake, is that they still don’t believe they’re getting the accuracy that they expect (e.g., Inconsistencies like data missing or it not being entered into the right field). There’s a great deal of frustration with today’s process and the volume of cases that companies are receiving are growing exponentially. Therefore, the workforce is extremely challenged to keep up with it. Companies are looking to invest in the area of case intake because, they know there is a large return on their investment.

Therefore, they are implementing these intake tools that are have incorporated technology like AI/ML and automation. All the technologies that that we’ve been hearing about for many years are finally coming to fruition and by using these technologies we’re seeing companies reduce the time that they’re spending on cases from what previous was 30% to 50% to maybe 20% or even 0% depending on the data received and the type of case. They’re also seeing consistent data entry. For example, the AI tool they’re using is only going to spell hospitalization one way. You don’t have to worry about different standards and people mistyping. They’re getting a higher degree of data quality which is providing them a tremendous amount of downstream efficiencies in regards to signaling and reporting and many of the other downstream type of processes.

What companies are finding is that they need less people for this part of the process given these tools. This, however, doesn’t mean that they are reducing their workforce, but rather looking to reposition their employees to be more strategic and to work on other areas that really do use and require human input. Of course, there’s still going to be many human interventions in the Case Intake process even with technology, however, we will also talk about a “touchless” processing where basically humans aren’t even looking at the case.

Now we will discuss some of the key features that case intake systems should have and some of the pros and the cons of the systems, along with factors to be aware of when evaluating a case intake tool. We will discuss what functionality is needed relative to the general steps of the case intake process. These case intake process steps are fairly standard although companies may have different or additional steps included or reorder them differently, however, we will discuss a general workflow that we see with clients.

The General Case Intake Process Steps

In the general case intake process

• Data Acquisition – the company will acquire the data from some source.
• Case Validity – next it will be checked that it’s a valid case.
• Duplicate Check – They will see if it’s a duplicate or a follow-up.
• Prioritization – If it’s not a duplicate, then it’s prioritized.
• Translation – next, if needed, it will be translated to English.
• Medical Coding – this is where the medical terminology specific to this case is added and checked.
• Alert for Cases of Interest – if there is an alert that needs to go out for cases of special interest, for example, a death case or a specific drug reaction combination.
• Case Intake Review – once all that is done the case is reviewed to ensure that all the data is entered and is correct before handing it off to Case Processing.

Let’s now take a closer look at Data Acquisition and Case Validity steps in more detail and the functionality required to ensure accuracy.

Data Acquisition

In the first step in the process, data acquisition, we’re getting information from all sorts of sources. Whether it’s from a spontaneous report, literature, a partner, a regulatory agency, or your Call Center.

We see them coming in from many different sources and through various channels. Companies are receiving e-mails, faxes, E2B messages as well as other electronic formats. We’re also starting to see companies leveraging social media to extract cases. Moreover, you may have a partner and there’s a shared file folder. There may be other sources that you have as well.

One of the key features that you want from your system in this area is the ability to not only receive all these types of information or reports, but also to receive them in their particular format. If you have an intake tool that can only bring in e-mail and electronic formats and you can’t receive a e-fax or a file folder, this can cause issues. You need to be able to receive all the cases in the various formats through the tool to be efficient. Because, if you’re having that mixed process of some pieces being automated and some are being manual, it becomes very cumbersome. We have seen companies miss cases due to this mixed process. So, the first thing that we need to ensure is that the tool will allow you to receive all of the type of reports that you get, in the different modes that you receive them.

Key Take-away – When a system can’t handle a particular source (e.g., Social Media), there are options that can be utilized to automate porting of data to the Intake tool.

Case Validity

With case validity, we need to ensure that the case has the main four elements (i.e., patient, reporter, adverse events, and product).  It’s imperative that the tool can do this. The tool needs to be able to extract or look at the file that is received and can extract and recognize all four of these elements to ensure it’s a valid case. It needs to also ensure that if it doesn’t have all four of these elements that it brings that case to a different part in the workflow or to a case list. In this scenario, you may have some human review to ensure that there isn’t something that is missed. It’s important to note that different systems do it differently.

A classic example that shows the importance of this is the “cat fax case”. The story goes like this. The company received a fax of literally a picture of a cat. Somehow the system received it as a death case that had all four of these valid elements. Now of course, that system needs to be trained better, however, that’s more the anomaly. You do want the system to be extremely efficient at this and to ensure that all the cases that are valid are coming through into your workflow and processed appropriately.

Key Take-Away You’ll need to have a process in place to manage a receipt that doesn’t have the 4 elements.

Summary

It is critically important, when looking to incorporate new technology into your business, that you ensure you have the right external organizations involved who can assist you. Formulating the appropriate strategy along with the proper processes, and technology is imperative. Astrix’s team of professionals have worked with many of the top life science organizations to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

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.