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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