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.





A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

For over 20 years, there have been Health Authority regulations governing the use of Electronic Records and Electronic Signatures (eReS) for GxP purposes. These regulations (the US part 11, the EU Annex 11, and their ilk globally) are arguably among the most elegant, concise, and consistent across jurisdictions (with differences mostly limited to context and emphasis rather than substance).

That being said, there has been a considerable amount of confusion in interpreting and applying the eReS regulations as both the Regulators and those in Industry have evolved their understanding of these regulations as the various guidance documents have emerged, been rescinded, revised, re-issued, clarified, etc.

This latest guidance document (which can and should be read in its entirety here (21 pages):, is very mature in its outlook and takes what has come before and builds upon it. The result adds a huge amount of clarity by specifically expounding on the general theme “This what we want, yes it means exactly that, and yes we understand the practical considerations and resource impact of what we want”.

Some key items in the guidance include:

  • Its application is intended across all GxP areas (Excepting Medical Devices – which I found interesting)
  • The principles of data integrity (which are separate from those of data quality) are meant to be adaptable, and are designed to evolve with Technology and promote a risk-based approach.
  • The non-technical aspects of data integrity are addressed, including the organizational responsibility to create a culture and environment (controls) that ensures that data is complete, consistent, and accurate in all forms (They focus on the oft neglected idea that PEOPLE are part of the process).
  • They revisit both ALOCA and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available. They go on to clarify that these two acronyms are differing ways of explaining the same expectations.
  • Differing paper, electronic, hybrid scenarios are discussed as are the ideas around Risk, Risk mitigation, and documentation around both. Warnings are made about poor organizational controls and the over-reliance on a system’s validated state.
  • Challenges and considerations around designing data processes and controls are discussed in some detail.
  • Key definitions are explained in some detail for: Data, ALCOA, Raw = Source Data, Metadata, Data Integrity, Data Governance, Data Lifecycle, Recording & collection of data, Data transfer & migration, Data Processing, Data Exclusion, True Copy, Transactional data, Audit Trail, Reconstructability, Electronic Signatures, Data review and approval, Data Retention/Backup/Archival, System Access, the Admin Role, Validation, and IT Suppliers including Cloud providers).


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



Source: Novartis goes digital with FocalView for ophthalmology clinical trials

Alexa, Fitbit and Apple Watch are your digital snitches – CNET

Alexa is always listening…..



Source: Alexa, Fitbit and Apple Watch are your digital snitches – CNET


Your Alexa and Fitbit can testify against you in court

In today’s digital world, Big Brother may be on your wrist, in your room — or inside your heart.



Ted Talk Statistics

I found this Ted Talk Statistics Ted Talk to be very entertaining….Enjoy



That’s where I’d go to cry…

A few months ago, I underwent surprise heart surgery to repair my mitral valve (it was leaking in a major way). I have the explanation that I give to people that ask about it down pat. I vainly make sure they know it wasn’t a heart attack, that I don’t have clogged arteries, that it was a genetic defect, that in all other ways I’m completely healthy, that it wasn’t my fault. I am not shy about it when they ask.


And ask they do. “How are you feeling?” “What happened?” “Do you have any restrictions?”  And comment. “We really missed you”. “It is so good to have you back”. “My husband had something very similar; feel free to call him if you have any questions”. (I never did). “You look great”. “I’m so impressed at how quickly you’re recovering”. “You do a 5k every day? That’s great!” “Wow, I didn’t expect to see you back at the boxing gym so soon”.  “You’re coaching soccer again! That’s great!” “How are you feeling?” The support and good sentiments have been overwhelming. People at work, people on facebook, neighbors, friends, family. They all let me know how much they care and I really appreciate all of it. But that’s not what I wanted to share just now.


My wife, Susan, has been a rock during all of this. She really kept it all together: watched over me while I was in the hospital, kept the kids grounded, waited for me during during my diagnostic and repair surgeries, and took care of me when I got home. And while having surgery (and particularly cardiac surgery) is a scarey thing, I think it is much worse for the significant others than for the actual patient. This was brought home to me when during a post surgery checkup at the hospital, I noted a bank of windows along a corridor that I hadn’t noticed before and commented on them to Sue (who had driven me and accompanied me to the appointment). She looked sadly at me and told me, “Yeah, that’s where I’d go to cry”. I looked at her, a little bit startled.


She had to see me with heart monitors, oxygen masks, eKG leads, tubes, tubes, and more tubes all coming out of me. She had to watch them prep me for procedures. She had to wait while I was in surgery. For. Six. Hours.  She had to go home and explain to preteen children what was going on without unduly scaring them. She had to keep it all together for them. She had to contemplate the prospect that she might be planning a funeral shortly. She had to spend time beating herself up with guilt over symptoms that neither of us noticed in the moment, but suddenly remembered in retrospect.  After I was home,  she had to help me into and out of the shower, get things for me,  drive me places, help me on the stairs, see me in my weakened state. She spent a lot of time blaming herself for something that wasn’t her fault.


So she saved most of her crying for that lonely hospital corridor.


Like me, she gets a lot of questions, but unlike me, the questions she gets usually aren’t about how she’s doing. They’re about me, about how I’m doing. “How’s Tim?” “I saw Tim’s picture on Facebook, he looks great!” “Is Tim doing ok?” “Is he back to work yet?” “We were so happy to hear about his recovery” “How’s Tim?”Don’t get me wrong, there were those who made sure she was ok. Joanne took care of the kids. Michelle took care of Sue and stayed with her during the surgery. And Tara made sure the family was fed. I can never thank them enough. The medical team at Saddleback Memorial were also great, both in their care of me and in their sensitivity to Sue. There were others who were looking out for her, but for the most part, it has been all about me.


So, I offer up these thoughts and observations to thank my wife for going through it all for me (Love you, sweets!), to thank those who looked after her, and to highlight in a small way how much harder it can be for those who wait, for those who need a place to cry.

Hear Hear, Apple! Hear Hear, Google!

In a move of solidarity, Google supports Apple in its fight against the US government to provide a “back door” into the popular iPhone…a move that would allow the government to hack  all of Apple’s customers.

#privacy #nobackdoor


Here’s what Google’s CEO just said about Apple’s battle with the FBI

The radical plan to destroy time zones – The Washington Post

I would love this. “What time is it on Earth?” #UTC

Continental to Cancel Flights to Avoid Fines

As a business traveler, this is troubling news:

Due to the government’s knee-jerk reaction, the cost of travel will be rising sharply. Now, I hate getting trapped on the plane too, but the cost of these fine (and the costs associated with avoiding them) *will* be passed on to consumers….as will difficulty in getting where we’re going. Sounds like a great idea, doesn’t it?


Defending Pharma

As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”.  Let me start by saying that Pharma is a for-profit business like any other.

I think it is important to note that neither pharma (nor the insurance industry for that matter) has particularly high profitability (ROE %’s). The following industries have a higher ROE % (Return on Equity rating) than Pharma (21 of them, and in the order listed). Cigarettes has nearly triple Pharma’s profitibility (and the US Gov is a de facto share holder); Aerospace has double. So why would Pharma be expected to foot the healthcare bill (and squeal like a pig -to paraphrase Congressman Marion Berry of Arkansas) when there are so many other more deserving candidates?



Aerospace/Defense – Major Diversified

Information & Delivery Services

Diversified Computer Systems

Cleaning Products

Beverages – Wineries & Distillers

Processed & Packaged Goods

Auto Parts Stores

Education & Training Services

Application Software

Personal Services

Food Wholesale

Industrial Metals & Minerals


Gas Utilities

Management Services

Personal Products

Personal Computers

Agricultural Chemicals

Diversified Communication

Electronics Stores