Mobile eTMF: The Pain of Yesterday. The Relief of Today.

Since the launch of myTI—TransPerfect’s mobile experience for the Trial Interactive eTMF—I have heard rave reviews from clinical operations leaders and CRAs. The advantages of mobile technology for clinical operations are generating a lot of excitement, and rightfully so. In my collaboration with study teams during the development, release, and ongoing evolution of myTI, we encountered many thematic pain points that were ripe for a mobile solution.

One CRA spent an entire month at sites conducting monitor visits, without any opportunity to return to the office and only being able to go home on weekends. This presented significant logistical challenges for managing TMF tasks, and this scenario was only one of several thematic pain points for CRAs. Luckily, many of their challenges can be easily resolved with a mobile eTMF experience.

Here are six other common pain points faced by CRAs and the relief a mobile eTMF experience provides:

1. Pain: Some CRAs are downloading/using non-compliant scanning applications on their devices to simplify the process of scanning documents on the go. However, the documents scanned on these non-compliant apps end up stored in non-compliant locations, creating unnecessary risk for study teams. This is a very significant compliance red flag.

Relief: A mobile eTMF app provides the convenience of mobile scanning with none of the compliance risk. Documents are submitted directly to the eTMF and are not stored on the device or in an unsecure cloud hosting environment. Make sure any app you use is 21 CFR Part 11 compliant!

2. Pain: There are boxes and boxes of binders lining offices and basements that need to be sent to scanning facilities—adding a significant expense. Not to mention being environmentally unfriendly!

Relief: Less paper transport and the steep costs that are associated—such as scanning/printing supplies, shipping, shredding, and proper disposal—is required when you can just pull out your phone or tablet and start scanning.

3. Pain: There are often a limited number of scanners at sites, a problem that can be compounded by password and other technical issues when trying to scan and email documents. This can lead to interruptions for other site personnel.

Relief: Technical obstacles are reduced when all you need to do is launch the application from your phone, like you would any mobile app. Fast, easy, secure, and compliant!

4. Pain: Many CRAs carry bulky, antiquated portable scanners around with them. These machines are cumbersome, heavy, and often difficult to set up—not to mention the scanning quality is subpar. Can you imagine traveling with a portable scanner and going through airport security?

Relief: Your personal device replaces the clunky portable scanner. The image quality is fantastic with the use of modern phone and tablet cameras and application features that detect documents, correct perspective, and enable review prior to submission to the eTMF.

5. Pain: Many CRAs who are primarily focused on getting documents into the eTMF do not have regular computer access, are not as comfortable working inside of a full desktop eTMF experience, or have time management challenges with switching from scanning to finding a computer to handle the uploading, filing, and coding of documents. Others just don’t like being tied to a computer. These inefficiencies compound and contribute to documents taking longer to process into the eTMF.

Relief: A mobile application offers ultimate accessibility to CRAs. They no longer need to find a computer to review eTMF completeness and see what’s outstanding, queried, expired, missing, or rejected. CRAs can enjoy a streamlined experience that provides only the features they really need to get their work done. This accessibility removes many of the bottlenecks that slow down document processing.

6. Pain: Many CRAs complain about disparate systems and passwords and resort to antiquated, paper methods to avoid the hassle. They are choosing between the better of two evils—both of which slow them down.

Relief: Logging into the system is no hassle when you can use your own biometric ID. It takes just seconds to access your application using Face ID or Touch ID.

Study teams using a mobile eTMF are thrilled with these advantages. As digital native generations enter the workforce, the expectation for highly usable, mobile-enabled technology is becoming the norm. In process-driven, compliance-focused work, people crave any efficiency that can remove distractions and obstacles that slow them down and/or create unnecessary risks.

Trial Interactive launched myTI in 2017, and it has become abundantly clear that a mobile eTMF experience has a welcome home in the day-to-day lives of CRAs. We’re excited to continue to explore the possibilities of what mobile technology can do for study teams, and have been grateful to our users for providing insight into the pain points that can be resolved with mobile technology. Together we will continue to explore all of the possible places we can provide relief to CRAs.

Learn more about myTI here or contact our experts anytime to discuss mobile eTMF at info@trialinteractive.com.