A single incident can generate many notifications. For a large pharmaceutical company or CRO, the scale is enormous—with tens of thousands of notifications being distributed every day to dozens of countries. Each country may have its own rules and regulations.
More is Not Better
In the past, sponsors would typically fax letters or use an overnight service. It was inefficient and often expensive, with no assurance the notifications were actually received. Some sponsors still do, but most have moved moving toward automated approaches—at a minimum, email.
A Broken System
Clearly, the safety-letter distribution process needs substantial changes to overcome these issues. That requires an upfront investment, but it yields a tremendous return. The ROI can be around 10:1, but it’s all future dollars, and it takes work to realize those savings. Moreover, we’ve discovered that many sponsors don’t have a baseline: They can’t envision how much they will save, because they don’t know how much they are spending.
Sponsors rarely have a way of knowing that all the appropriate documents were sent to all the appropriate parties. So when an inspection or investigation occurs, they discover that the notifications were never received. Or perhaps, more accurately, they discover they cannot verify receipt, which is essentially the same thing for audit purposes. Before working with us, one client was underreporting events by 2 million cases. To adequately monitor compliance, sponsors need to be able to track a particular SUSAR to a particular investigator. For example, because our technology embeds trackers in our emails, 98% percent of the time we can tell when it arrives in an investigator’s mailbox. Sponsors have complete transparency, which instills confidence. They can click a button and see how many investigators and sites are compliant, when they last logged on and who hasn’t acknowledged what.
- User-friendly Investigator interface
For the investigator, you want the user experience to be simple. Investigators need to focus their time on research, not on trying to access the dashboard.
The simplicity of the site interface is only part of it. Let’s say a sponsor has 10 studies in one therapeutic area. SUSAR distributions occur at the compound level. That means the same SUSAR goes to 10 separate studies—each study using that compound. In a conventional system, an investigator working on three of those 10 studies receives the same document three times and must acknowledge it each time.
Ideally, you want the investigator to get the document once, acknowledge it once, and receive credit for all the studies they’re working on.
- Automation that reduces human error
The right safety reporting solution reduces human error by eliminating manual data entry. Data-entry errors are common in our industry. You want a safety reporting solution that will integrate with and pull information from clinical trial management systems, safety databases, trial master files, shared investigator platforms, etc.
- Functionality that improves patient care
Eliminating unnecessary notifications has a direct impact on patient care. First, consider the hours each site would save every week. That’s time they can spend with their patients. Perhaps more important, sites can better ensure patient safety. Sites are supposed to use SUSARs to talk with their patients and check for the symptoms described. When sites receive only the relevant and important notices, they can do this. When sites are being flooded with information, they may miss a crucial alert, putting patients at risk.
- Provide global harmonization
In large trials, sponsors must keep up with hundreds of evolving country-specific rules. Any safety-letter distribution solution must allow sponsors to distribute SUSARs based on each country’s requirements.
The current approach to safety reporting is costly and inefficient, burdening sites, frustrating investigators and putting trials in jeopardy. Worst of all, it puts patient safety at risk. It’s time for a change.
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