Why Your Spreadsheets Suck
And why there are better ways to manage clinical trials.
In clinical trials today, it’s not uncommon for four or five organizations — including sponsoring academic institutions, federal regulatory bodies, and technology companies like TypeZero — to collaborate on a single clinical study. It’s also not uncommon for each of these parties to play an active role in resolving issues and problems reported during a trial. For medical device and software providers in particular, gathering detailed feedback and data is critical once their product is launched into the field for the first time, which often occurs in the context of a clinical trial.
When a potential problem or bug is discovered during field testing, the accurate transmission of information from the customer (the clinical trial subjects) to clinical study staff to software providers can be a tenuous game of telephone. Without appropriate issue management and tracking mechanisms in place, keeping up with all the moving pieces across multiple communication channels can become as taxing as solving the problem itself.
From our perspective, traditional issue management and tracking tools like Excel spreadsheets are inadequate for use in clinical trials. Excel obstructs visibility, lacks robust documentation features, and ultimately delays the pace at which problems can be resolved by technical troubleshooting teams. Here are four reasons why ticket management software is superior to traditional Excel spreadsheets for reporting, managing and tracking an issue throughout its lifecycle.
Capturing Required Data
Clinical trial subjects liaise almost elusively with members of the study team during a trial, but medical software and device providers are expected to address and resolve serious safety-related concerns raised by subjects. Before providers like TypeZero can dissect and triage a reported problem, they need a significant amount detail around what went wrong, when the problem occurred, what the subject was doing, and a host of other circumstantial data. While Excel spreadsheets may suffice for one sentence issue summaries, what happens when you need to append supplementary documents or graphics? Include an email communication or data download? Data capture is where service desk and ticket management tools like JIRA Service Desk, Zendesk, and Zoho far eclipse Excel spreadsheets. One, they provide a easy-to-upload platform, and secondly they allow technical providers to specify and require the exact information needed to troubleshoot a problem. This means subjects and clinical study staff don’t have to speculate about what data to collect and send. In JIRA Service Desk, for example, technical troubleshooting teams can make certain entry fields like issue summaries, priority levels, and supplementary attachments required before an issue can be submitted.
Ticket management tools can also add significant value to clinical trial issue resolution by providing broad visibility. They allow users to view the most up-to-date issue submissions, related communications, ancillary documents, and a specific ticket’s position in the workflow at any given time. If you’re tracking issues in Excel spreadsheets, you can’t really be sure if you have the most current copy or if the latest details or status have been added yet. Housing issues in a central, easily accessible ticket management system eliminates this reliance on transmitting documents and correspondence via static Excel spreadsheets. Ticket management software alo allows troubleshooting teams to grant customized access to projects (the bucket where issues are collected) on individual or group-wide bases, meaning stakeholders can have full visibility into an issue portal to catch the latest on an issue.
Tools like JIRA Service Desk also promote accountability. Dozens of issues may be reported within a single day during a clinical trial, so it’s critical to know exactly who is on point to manage a particular problem. Clearly defined ownership matters when you’re dealing with issues in volume; it eliminates ambiguity and confusion around who’s currently accountable for running them to ground. If work is assigned via an Excel spreadsheet, how is the assignee notified? If you’re collaborating with multiple parties on a problem, is it clear who’s the lead? If ownership is re-assigned, how is that change communicated? This is a key shortcoming of managing issues in Excel, as specific responsibilities and tasks are often left unclear, unassigned, and untrackable. Ticket management tools, however, clearly delineate who’s currently triaging a reported problem. Most systems permit auto-assigning of issues, enable easy and trackable transitions between individuals and teams, and offer follower or watcher features.
Customizable and Scalable
In terms of customizability, Excel spreadsheets are static tools. The scale and design of clinical trials vary widely, and ticket management systems are highly customizable to handle this variability. Depending on the process through which issues are reported in a given clinical study, device and software providers can design workflows and transitions, configure approval structures, and tailor user-facing content. You can activate the features you need and hide the ones you don’t. You can also create self-service Q&A repositories, or knowledge bases, so subjects and clinical study staff can find the answer to commonly reported issues on their own. In addition, most ticket management platforms are highly scalable and priced on a per-user basis, giving technical troubleshooting teams the flexibility to add and delete users as needed.
At TypeZero, we waved goodbye to traditional Excel sheets in favor of JIRA Service Desk long ago. The customizable features and extensive issue management toolkit are top-notch, but most importantly it helps us address technical issues reported by our clinical trial partners efficiently and transparently.
For more on why we recommend using ticket management tools over Excel for clinical trial issue management, check out these articles.