Considerations on the use of Mobile eCOA/ePRO Technology in Clinical Trials

I’m going to be providing this training internally at my company. I’m wondering if it is of interest externally as well….

The use of Electronic Clinical Outcome Assessments (eCOA) or Electronic Patient Reported Outcomes (ePRO) via mobile devices (smart phones, tablets, etc.) has been evolving and expanding in recent years. As an industry, we’ve conquered some of the early challenges experienced with the use of these devices in the clinic, usually on lower risk data and often with a paper backup process in place. However, as we move forward with increasingly complex devices and data collection schemas for higher risk efficacy/safety data the stakes have raised. Adding to this risk is the advent of adaptive trial design and increased time pressures in clinical research. New challenges have emerged that need to be considered and mitigated as we move forward with the promise these technologies hold in the improvement of trial design and data quality. This training is designed to enhance the understanding of professionals in all areas of clinical research (Clinical Operations, Monitoring, Clinical Scientists, Data Management, Biostats, Medical Writing, etc.)  and the service organizations that support them (IT, Procurement, Contract Management, Quality, RA, Safety, etc.) including Senior Leadership who drive the initiatives to adopt best-in-class tools and design.

Thoughts?

~TJK

 

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Novartis goes digital with FocalView for ophthalmology clinical trials

(Image: Getty/demaerre)May you live in interesting times… A colleague flagged this for me. I’ll be very interested in the particulars of how this all works going forward. #ItsAllAboutApps

 

~TJK

Source: Novartis goes digital with FocalView for ophthalmology clinical trials

SQA Thoughts after Catching Up on some Work

They say that no good goes unpunished….That goes doubly for attending a week-long off-site conference/training. I’ve been back from SQA for over two weeks now and am just getting to a place that might be called “caught up”.

Overall, the conference was good. I had some time away from the office to recharge, reflect, and learn. I saw some old friends and met a few new ones. The pre-conference train courses were quite good:

1) Basic GLP – Pre-clinical is an area in which I haven’t worked directly and I think it is best to always stretch at these opportunities and learn something new. I came in second in GLP Jeopardy!

2) Current Topics in GCP (formerly entitled Advanced Topics in GCP) – This is one of the areas in which I currently live and breath; so I heartily enjoyed this session. It included several former/current FDA employees who really added a lot to the course and the subsequent discussions.

During the conference proper, I focused primarily on Clinical and Validation sessions. There were a lot of good ideas and questions at these sessions too, but I really find that I get a lot more out of the intimate, all-day training classes because of the opportunity to really drill down into a topic and explore lots of related ideas and experiences.

Anyway, I’d better get back to it. I’ve been implementing a training program at work related to “Good Documentation Practices for Clinical Validation Projects” that has been taking quite a bit of time. It has generated a lot of good discussion and the response has been very good. Time permitting, I may post some of my support materials.

~TJK