The Five Must-Haves in Automated SUSAR Distribution

Apr 05, 2016


You may feel differently, but I can’t imagine anyone arguing against working smarter, not harder. Yet some companies continue to slog through the SUSAR notification process manually – gathering the available staff to help with preparing cover letters, printing, collating, packaging and mailing or sending by expensive courier. This gets repeated for each SUSAR, for each trial. Other companies decide it’s simply easier to bear the cost of outsourcing the safety report notification effort to a CRO.

The use of an automated solution to handle the entire process is the third alternative for a growing number of companies. No two solutions are exactly alike, so what are the “must have” functionalities to look for when considering and evaluating different offerings? Let me first share that while my professional title shows me as an ArisGlobal “subject matter expert” for clinical development, this is based on my years in the pharmaceutical industry working closely with companies to lead both clinical operations and clinical data management projects. I am also the product manager for agNotify™, ArisGlobal’s automated SUSAR notification solution, and the following “must have” list is based on what I’ve learned from a number of customers who adopted our automated solution. Here’s what most companies asked and are seeking:

#1: Can the solution enable me to quickly send safety notifications based on different report types and to my list of investigators, IRBs, ethics committees and other stakeholders?

This, of course, is the primary purpose of an automated solution, and the solution you select should give the functionality that can:

Generate lists based on user-defined distribution rules and provide a workflow-driven review and approval process to ensure the right people will receive the notification

Distribute safety notifications based on study and/or product

Distribute individual case reports and/or aggregate summary reports as necessary

Handle a cross study. For example, if it’s a drug that’s used in several studies, you also need to report to the investigators and stakeholders in those other studies

Upload and distribute different report types such as CIOMS or FDA 3550A (blinded or un-blinded) so that each investigator receives the required report type

#2: In tandem, can the solution also subsequently track all receipt acknowledgments and quickly generate the necessary reports to prove compliance and respond to inspectors / auditors?

Before an inspector or auditor requires your company to prove its complete compliance, you want to be fully confident that your SUSAR distribution solution can handle such activities as:

Automatically track read acknowledgments upon an investigator’s clicking on a safety report in the portal they access after receiving an email alert

Archive all safety reports

Generate detailed transaction history reports and documentation for the TMF (trial master file)

#3: Will the solution be able to handle my current / future global requirements?

More often than not, today’s clinical trial involves investigators located in different global countries, and that dynamic will only continue to reinforce the need for a solution that can handle all of the varying global requirements. It’s important, therefore, that a SUSAR distribution solution is 21 CFR Part 11 compliant with international regulations and gives its users the ability to:

Automatically generate cover letters in the native language based on user-defined templates, with different templates available for different countries

Deliver the type of report required (in the U.S., it’s the MedWatch report, while outside the U.S., it’s the CIOMS report)

#4: Does the solution help our investigators to stay easily informed?

When all is said and done, an automated SUSAR distribution solution won’t be successful unless it is easy for your investigators to have access to the specific safety information awaiting their attention. Certainly for expedience and cost savings, the preferred method for informing investigators and others would be through the use of a Web portal. The reality, however, is that for some recipients, email or Web access may not be readily available or just simply not preferred due to individual preference. It is simply not enough for a sponsor to say to auditors and inspectors, “I sent an email about the SUSAR, so I fulfilled my duties.” An automated solution should give a Sponsor the ability to:

Give investigators the option to select their preferred method of receipt. For example, if they do not have reliable access to the Internet, the solution should let them choose postal/courier, fax and email-based distribution

Provide automatic tracking of successful or failed fax or email transmissions

Enable the Web portal to be opened for manual tracking if delivery is via mail or courier service

Provide automatic reminders to investigators when a notification has yet to be acknowledged

#5: Will we be able to leverage our current CTMS and Safety systems for further process improvements?

Companies want assurance that the automated solution they select offers the power of integration with clinical and safety systems for improved efficiencies, even if it’s not something they want to adopt right from the start. It’s important to learn if the solution offers:

Out-of-the box and easy integration with your clinical trial management system so that the data typically stored in the CTMS can be used for the automatic generation of distribution lists

Out of the box and easy integration with your safety system. Using agNotify as an example, once a case qualifies for expedited reporting, pharmacovigilance users can easily send the case from the safety database to agNotify™ for further processing

While there are other factors that can influence your solution evaluation process, I hope this list of five “must haves” give you a baseline from which to start. I welcome your feedback to this post, and I encourage you to attend our December 10 webinar, “SUSAR Distribution: A Process Perspective.” You can also check out our infographic and on-demand webinar, “Automated Safety Report Distribution: Where Are the Cost Savings?”