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T 17: Mobile CRAs: Transforming Clinical Monitoring Processes through Mobile Technology

Poster Presenter

Xiu Wei Lim

Regional Clinical Innovation and Operational Excellence Head
Quintiles
Singapore

Objectives

This investigation looked at comparing CRA’s on-site delivery through specific mobile applications developed specially for clinical monitoring; with the main aim to access the potential productivity and quality gain as compared to the current processes.

Method

ORAL PRESENTATION SCHEDULED: Session 1B at 12:20 - 12:30 PM

CRA delivery in Asia was assessed for this investigation. Four mobile applications were introduced and grouped (save time, improve quality, both) where qualitative and quantitative assessments were made before and after the introduction of these tools.

Results

The following four mobile applications were deployed in Asia between 2015- 2016 to aid an on-site CRA: CRAs were accessed based on the average time used in conducting a particular task using the mobile app vs conventional method. Median rate of time saved is calculated. 1. IP Calculator: Calculate patient’s drug intake compliance. a. Productivity: 3.54H/ CRA/ year b. Quality: Reduce human calculation error by reducing variation of processes 2. Subject Visit Scheduler: Calculate the acceptable visit window range of a patient & keep track of patient actual visit date. a. Productivity: 0.97H/ CRA/ year b. Quality: Reduce human calculation error by reducing variation of processes, good reference for site to remind patients, reduce visit window related PDs, enables CRA to have oversight of patient visit window before going to site 3. Mobile Camera Scanner: Provides high quality scanned documents & print outs, saves printing time when a CRAs are at site where photocopier may be located far from their work station. a. Productivity: 7.76H/ CRA/ year b. Quality: Comparable and better scanned/ print quality as compared to some photocopier and scanner. 4. Prohibited ConMed: Protocol & country specific drug directory that display information of a searched drug and if the is allowed, prohibited or restricted. a. Productivity: 16.88H/ CRA/ year b. Quality: Reduce the need of cross reference of several documents and reduce human error. Overall results shown that mobile applications catered specifically for clinical monitoring drives improvements in terms of time save, compliance, consistency and potential reduction in quality related incidents.

Conclusion

While the clinical research industry has sometimes lagged behind others in the adoption of mobile technology, mobile diagnosis, wearable technology and patient-focused applications have all seen a number of recent advancements. Where there is still a gap is in the usage of such tools to improve the clinical development and the clinical monitoring process itself. By identifying specific key and unique activities that CRAs execute during on-site monitoring, we were able to identify and develop a number of mobile applications to improve the efficiency of the monitoring processes. Usage of these mobile tools led to significant time and cost savings, as well as improvements in quality and patient safety. One example would be the Prohibited ConMed App, which provides an automated method for assessing concomitant medications alone, was able to save approximately 17 hours of on-site time per CRA, per year. By scaling to the magnitude of CRAs across the globe, the time savings would be enormous. With clinical research attributing approximately 70% of drug development costs, which can amount to more than $37,000 per day, there is an urgent need to address productivity in trials. Further assessment of clinical trial and monitoring processes through the lens of mobile technology will surely allow further improvements in this area – reducing costs, accelerating development time and improving the rate at which new drugs reach patients.