The gap between the proletariat and Medidata (or should I say Dassault)

We need a better UX before [TLA] integration

The sheer number and variety of eClinical software companies and buzzwords confuses me.
There is EDC, CTMS, IWRS, IVRS, IWRS, IRT, eSource, eCOA, ePRO and a bunch of more TLAs.
For the life of me I do not understand the difference between eCOA and ePRO and why we need 2 buzzwords for patient reporting.

Here is marketing collateral from a CRO.   As you will see – they miss the boat on all the things that are important for site coordinators and study monitors.

We adapt responsively to change in your clinical trial to minimize risk and drive quality outcomes. Clinical research is complicated and it’s easy to get off track due to inexperienced project leaders, inflexible workflows, or the failure to identify risks before they become issues. We derive expert insights from evidence-based processes and strategic services to be the driving force behind quality outcomes, including optimized data, patient safety, reduced time-to-market, and operational savings.

What CRCs and CRAs have to say about the leading eClinical solutions

I recently did an informal poll on Facebook of what problems the CRA/CRC proletariat have to deal with on the job.

I want to thank Tsvetina Dencheva for helping me grok and distill people’s complaints
into 3 central themes.

Theme no. 1 – enter data once

Enable administrators to enter data once and have their authorized user lists, sites and metrics update automatically without all kinds of double and triple work and fancy import/export footwork between different systems. Failing a way of managing things in one place –
at least have better integration between the EDC and the CTMS.

The IT guys euphemistically call this problem information silos. I’ve always thought that they used the word silos (which are used to store animal food) as way of identifying with people who farm, without actually having to get their hands dirty by shovelling silage (which is really smelly btw).

I understand the rationale for having a CTMS and an EDC about as much as I understand the difference between eCOA and ePRO.

Here is some raw data from the informal Facebook survey

If I enter specific data, it would be great if there’s an integrated route to all fields connected to the said data. An easy example is – if I enter a visit, it transfers to my time sheet.

Same goes to contact reports. Apps! All sorts of apps, ctms, verified calculators, edc, ixrs, Electronic TMF. The list goes on and on. How could I forget electronic training logs? Electronic all sorts of log.

There are a lot of things we do day to day that are repetitive and can take away from actually moving studies forward. Thinking things like scanning reg docs, auto capturing of reg doc attributes (to a point), and integration to the TMF. Or better system integration, meaning where we enter a single data point (ie CTMS) and flowing to other systems (ie new site in CTMS, create new site in TMF. Enrolment metrics from EDC to CTMS) and so on.

If only the f**ing CTMS would work properly.

Theme number 2 – single sign-on.

The level of frustration with having to login to different systems is very high. The ultimate solution is to use social login – just login to the different systems with your Google Account and let Google/Firebase authenticate your identity.

Theme number 3 – data integrity

EDC edit check development eats up a lot of time and when poorly designed generates thousands of queries. Not good.

There is a vision of an EDC that understands the data semantics from context of the study protocol.

This is a very cool and advanced notion.

One of the study monitors put it like this:

The EDC should be smart enough to identify nonsense without having to develop a bunch of edit checks each time and have to deal with queries.

The EDC should be able to calculate if a visit is in a proper time window, or if imaging is in a proper time window. Also for oncology if RECIST 1.1 is used, then the EDC should be able to calculate: Body Surface Area, correct dosing based on weight and height of a patient, RECIST 1.1 tumor response and many other things that simply can be calculated.

About flaskdata.io

We specialise in faster submission for connected medical devices. We can shorten your
time to market by 9-12 months with automated patient compliance detection and response.

Call us and we’ll show you how. No buzzwords required.

What real-time data and Risk-based monitoring mean for your CRO

A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data.

RBM methods used by a central clinical trial  monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from patients, devices and investigators reduces the relevance and efficacy of remote monitoring.

Real-time data is a sine-que-non for RBM.

Sponsors and Contract research organizations (CROs) should therefore approach real-time data and risk-based monitoring (RBM) as 2 closely related priorities for executing clinical trials. Use of modern data technologies for real-time data collection and remote risk-based monitoring will reduce non-value added rework, people and paper in clinical trials and help speed up time to statistical report.

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The 3 tenets for designing a clinical data management system

Abstract:
This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t).

Enjoy!

The trend of DIY: good for EDC vendors, less good for sponsors

The trend for small studies/IIS (investigator-initiated studies) is to use cloud EDC applications
that enable end-users to build eCRF and edit checks using a graphical user interface. This so-called DIY (do-it-yourself) approach is used by most cloud EDC vendors such as Medrio and Clincapture as a way of lowering their barriers to entry to the market.

However – what is good for vendors (lowered barriers to entry) is not necessarily good for sponsors (faster time to market of their innovative drug or medical device).

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Millennials are the future of clinical trial data management

esource tp get smart to market

Millennials, born between 1980 and 2000 and the first native generation of the digital age, are the quickly approaching additions to the modern workforce. Regardless of whether private or public sector Millennials are soon to become the bulk of the global workforce.

At present, Millennials represent 34% of the current US workforce (up 9% from 25% in 2015), and by 2020 50% of workers will be of the Millennial generation. As the demographics of present job seekers continues to shift, companies need to adjust their culture, facilities and technology to cater to the new generation.

Regarding the clinical trial industry, Millennials are not only the next generation of data managers and monitors, but will soon make up the bulk of the study subjects as well.

Choosing the right tool and UX for millennial subjects becomes acute considering usability factors and patient compliance issues for people under 30.

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The great ripoff of SDV in medical device studies

medical device clinical trials

Question

Are you still doing 100% SDV in your medical device clinical trial?

Here are some facts from medical device clinical trials:

30% of your study budget is for monitoring and 50% of monitoring is for SDV

For a $1M study – you are spending $150k for SDV.

What do you get for your $150K?

Check the EDC and see what percent of  the data was updated due to SDV activity.   A study we did with 20 medical device studies shows that it is less than 1/3 of 1% for connected medical devices using ePRO ( the endpoint/patient compliance data is collected electronically).

Your return on investment was $525.

What does Risk-Based Monitoring mean for CROs?

It basically means a golden opportunity to shake-down the customer.

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How to overcome 5 eSource implementation challenges

Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro.

Frankly, its easier to talk about change for other people than for yourself. A lot easier.  I have written here, here and here about the gaps between the stakeholders in medical device clinical trials – security, IT, engineering, product marketing ,regulatory affairs and medical device security to name a few.

Overlook change management at your own risk

Change management is a topic usually overlooked when medtech companies implement cloud EDC, and introduce medical IoT for collecting data from patients directly and use electronic source documents for their connected device/mobile medical app or device clinical trial.

In this post, Jenya talks about how to manage change during the transition from traditional medical device clinical trial data management to cloud technologies, remote monitoring, medical IoT and electronic source data.

So enjoy.

Danny

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Cost effective EDC for medical device clinical trials

clinical data management

There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt for the paper default or the DIY option for monitoring. None of which are a particular good idea.

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