Hey, Study Teams! Let’s Go eTMF Mobile.

2018 is a big year for us—we’re celebrating 25 years of TransPerfect Life Sciences and 10 years of our e-clinical platform, Trial Interactive! Other 10-year anniversaries coinciding with ours are the Apple App Store, ClinicalTrials.gov, and CTTI (Clinical Trials Transformation Initiative), an organization committed to making clinical trials “more streamlined, efficient, and patient-focused”.

What do these anniversaries have in common? All are, through their own specific visions, part of a progression that is continuously exploring the edges of personalization, simplicity, efficiency, and convenience in day-to-day activities. Apple has created a playground of general innovation for business and personal use cases, while ClinicalTrials.gov, CTTI, TransPerfect Life Sciences, and Trial Interactive are focused on efficiency in clinical operations.

These matching anniversaries provide an analogy for the increasingly connected relationship between business operations and mobile experiences. It is thematic in innovation that the very things that entertain us can also be purposed for more practical endeavors. For example, innovations in gaming experiences have been adopted as “gamification” for corporate culture building and learning management.

Mobile technology is no different. According to Smart Insights, apps account for 89% of a user’s mobile media time, with the other 11% being spent on websites. In recent reports by Statista, as of January 2018, business apps (9.8% of apps on the App Store) are the second most popular category. In June 2017, more than 180 billion apps were downloaded from the App Store. Less than 10% of the apps on the App Store (which hosts over 2.2 million apps with 180 billion downloads) are capturing the number-two spot for all possible use cases. Apps and business appear to be fast friends.

Mobile has taken administrative tasks such as banking and tracking expenses and has simplified them to the point where they can be at your fingertips at all times. Let’s take Concur and Expensify as examples: both are pretty commonly found on people’s devices. These expense applications allow users to track, manage, review, and submit receipts and expense transactions. What was previously a headache, is now done on the go. Users can capture an image of a receipt for their records and review their expenses right from their mobile device. Managers can quickly review and approve expense reports. Not very long ago, I remember submitting expenses manually where each receipt had to be kept and the paper statement itself provided to Accounting. The new expense applications take paper out of the process, saving time, money, and paper!

The business processes in clinical trials are not so unique that they cannot benefit from similar efficiencies.  In fact, some of the functionality mentioned above applies—at least fundamentally—to key TMF processes.

The market-facing side of the Pharmaceutical industry has been quick to adopt mobile technology as a means to provide resources to doctors and patients. The Federal Trade Commission (FTC) has worked with the FDA (Food & Drug Administration), HHS (Health & Human Services), ONC (Office of the National Coordinator for Health Information Technology), and the OCR (Office for Civil Rights) to put together a comprehensive guide for those sponsors developing a mobile health app in the United States. In addition, CTTI has put together their recommendations around the use of mobile technology in clinical trials and the positive impacts such as “Patient Centricity, Efficacy, and Efficiency” benefits mobile technology provides.

Currently, there are hundreds of pharma apps on the App Store—sponsor companies are building their own patient apps, and wearable technology in clinical trials is playing a large role in data capture. In the November 2017 publication of Evidera, The Evidence Forum states that the National Institutes of Health clinical trials database reported over 400 studies for mobile app and over 300 for wearable tech. In addition, innovations like Apple’s ResearchKit and CareKit are making it easier to enhance the patient experience. Some breakthrough examples of clinical apps are No 483 For Me!  (designed for clinical research site staff) and mPower (a massive Parkinson’s Disease Study entirely on mobile, using sensors within the phone and wearables to collect data to monitor and understand the causes of symptoms). The pre- and post-market side of the Pharmaceutical and Medical Device industries are ready to enjoy similar innovation with on-the-go accessibility and focused, streamlined business processes in a slick mobile interface.

As discussed in a previous post, paper in clinical trials is becoming increasingly obsolete; the advantages of near-real-time transparency into clinical documentation and associated processes (TMF quality and completeness, for example) is even more important for regulators. Let’s imagine a world where the review process is much quicker: significant reductions in the transport of boxes of documents, massive reduction in risks of documentation being lost or damaged in transport (or loss due to a fire), and big savings on paper expenses, packaging, and transit costs. The amount of time that could be saved by and for the Clinical Research Associates at the investigative site by eliminating paper handling would help to keep everything in order, reduce the need for assistance from the office staff regarding security/passwords for printing and scanning machines, and negate the transfer and upload of the now-digital TMF documents into the eTMF. If no scanner exists at the facility (or it is broken, or perhaps the CRA does not have their own portable scanner) the CRA might have to photocopy the TMF and site documents and only then, once they’re at their home office (which could be weeks later), do they have the opportunity to scan and upload the documents. Such situations delay the documents anywhere from 30-60 days to getting into the system after the CRA’s site visit.

A mobile experience tailored to these processes could streamline and simplify the process using our own personal mobile devices to get documents quickly and safely into the TMF in real time while the CRAs are at the investigative site. CRAs and managers could get immediate access for comparing and reviewing the documents in the system and easily review document statuses, resolve queries, and view TMF completeness at a glance with visual reporting. Frequently Asked Questions, links to other portals used for the particular study, and a listing of study staff assigned at the site for the particular study also gives the CRA the opportunity to have all relevant site information, literally in the palm of their hand.

The great news is that these are no longer hypothetical advantages for clinical operations.

TransPerfect’s Trial Interactive has come a long way in the past 10 years. 2018 is the year we’re pushing our clinical suite of solutions even further with innovation, improvement of the user interfaces, and accessibility. It’s time for clinical to go mobile. Join us!

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Sources :

https://www.ctti-clinicaltrials.org/news/ctti-celebrates-decade-transforming-clinical-trials

https://www.ctti-clinicaltrials.org/files/novelendpoints-recs.pdf

https://www.statista.com/statistics/270291/popular-categories-in-the-app-store/

https://www.statista.com/statistics/263794/number-of-downloads-from-the-apple-app-store/

https://www.statista.com/statistics/276623/number-of-apps-available-in-leading-app-stores/

https://parkinsonsnewstoday.com/2016/03/07/sage-bionetworks-releases-first-of-its-kind-data-from-parkinsons-iphone-study/

http://sagebase.org/mobile-health/

https://www.nature.com/articles/sdata201611