Nov
08
Breaking News: Medidata Wins Risk Based Monitoring Award


hey guys ECR G here back with another
video today we’re gonna talk about risk based monitoring and not just any risk
based monitoring we’re gonna discuss metadata who has recently won an award
the at the Kerr awards for their risk-based monitoring solution and how
they call it as edge strategic monitoring that’s the name of their
product that they offer and I know myself and Clinical Research I’ve used
metadata products for a long time now I’ve used metadata CTMS and I’ve used
their rave system there EDC rave system for data entry which is pretty good and
it’s pretty cool how they can work together between the two platforms so
metadata is definitely a company in clinical research who’s pretty well
known has a pretty good reputation so it’s no surprise that they’re coming out
with new products and their products are becoming well-received by the clinical
research community now with that being said an article recently came across my
attention about how they won this award for the best sponsor focused
technological development in strategic risk based monitoring so congratulations
to metadata for winning that so we’re going to delve a little bit deeper into
that but before we do I just like to take a second to let you guys know about
the resume review program that we have going on right now if you’re new to
clinical research or interested in having your resume tightened up in
clinical research please shoot it over we are reviewing resumes right now and
you know just shoot it over our email is elite clinical group at gmail.com and
especially if you’re doing the clinical research we will definitely make you a
much more competitive applicant and to get into clinical research so back to
the metadata part metadata and to teaching monitoring was definitely you
know something that was definitely gonna be worked on by a lot of companies
because with the new I see gcp regulations that came out in 2016 we
knew that there was going to be a ink focus on risk-based monitoring now for
those of you who are new to clinical research and may not exactly know a risk
based monitoring is or how it compares to traditional monitoring or remote
monitoring you can go check out one of our videos on that we’ve done that
before but in a short summary basically risk-based monitoring is where you
assess where you have a risk profile based on sites and usually it’s visually
or in some kind of graph they’ll measure the action items open action items time
it takes for action items to be closed time it takes for queries to be closed
how many queries a site has etc etc they have all these data points on a site and
they usually show it visually so you can see okay this sites in the green that
means they’re good with a lot of things we can spend a little less time worrying
about that site or how about this site over here this sites in the red they’ve
got a lot of open action items they’ve got a lot of open queries we need to
spend a little bit more time on this site maybe do a little bit more
monitoring maybe send a monitor out there next month to tighten up some
things so that’s risk-based monitoring they
they put a risk profile on each site essentially and you can spend more time
and allocate more resources to the struggling sites so that’s risk based
monitoring and we knew this was going to be big so metadata came out with this
and they recently won an award April 2018 the care awards which
acknowledges and applause pharmaceutical industries outstanding innovators across
all areas of the industry recognizing both corporate and individual
achievements so you know here’s a quote from the article metadata strategic
monitoring suite is an exciting end to end solution to support effective
risk-based monitoring and workflow an area where many companies have developed
only partial solutions set the care award judges it enriches data quality
through early real-time unique insights and is the only technology that adheres
to AI chec guidelines as well as transcelerator risk based monitoring
functional requirements so this is pretty big
for metadata and you know I wanted to bring up their
website so bringing it in now about so maybe we can learn a bit more about
about this product and this is the third time in a row that they’ve wanted the
third year in a row that they’ve won this award so let’s see we can dig in a
little bit on here on the website so obviously it has to comply with ICS GCP
that’s probably the reason why they started this whole product let’s see we
can see we come in here the risk assessment assess impact probability
detectability of study risks configure and link k our eyes or key risk
indicator indicators analytics centralized analytics review known and
unknown risks through the use of statistical machine learning analytics
generate issues and act in actions and this this is pretty powerful of what
this eventually could be especially if you combine this with some AI where you
know the computer or yeah the computer essentially knows in advance where the
risks are gonna be and it can defend against that before they even happen
this could be incredibly powerful when it comes to running clinical trials so
let’s see what else it does visit preparations CRA reviews issues actions
created by centralized risk monitoring team prepares adaptive monitoring plan
focused on risks so visit conduct CRA completes assigned tests including
source data review root cause analysis and preventive corrective actions
documentation CRA captures visit conduct responses associated comments issues and
action items and visit report so you know the system already kind of does
that so it’s not really saying much about you know what else it does there I
mean actually I automatically go in the visit report as it is so here are some
of the features as I was looking for so enriched data quality through early
real-time and unique insights statistically analyzed millions of data
points identifying known and unknown risks anomalies outliers and patterns
assess impact of actions on and equality through configurable
workflows and care I performance tracking simplify data verification
process through configurable study and site-specific source data verification
so it’s been this is gonna be good now this is where the meet really is what
how is it going to save time how is it going to increase quality so enables
series to efficiently prepare for upcoming visits through simplified STV
SDR plans with advanced tracking and provide greater workflow efficiency and
reduce administrative burden on C arrays geez I’m gonna repeat that again reduce
administrative burden on CRA s jeez that is huge one of the big problems with
being a CRA is you’re not just focused on monitoring you’ve got to worry about
you know some of the other more administrative tasks like TMF everyone
hates TMF it’d be nice if you just collected the documents and sent them to
someone or uploaded them once it named them for you that’s the big thing about
TMF is the naming because every document you’ve got to save and name it be one
thing if you could just drag and drop and let the computer name them for you
so that’s that so yeah this is a commercial product and this is this is
gonna be big I think this is for sure gonna be big many clinical trials right
now are not using risk based monitoring so it’s only going to be new clinical
trials that are coming up that are going to be using the risk-based monitoring so
I mean I’ve read articles that are for and against it saying that you know it
can there’s gonna be more burden on the site for risk based monitoring because
if you think about if the computer is the one issuing action items and issuing
all these things for the site to do then that’s just gonna be a lot more work
rather before that the CRA would help them so we’ll see but I think this is
gonna be the future as soon as the kinks are worked out for Shore risk based
monitoring I mean it just makes sense why would you spend if you have a
problem child versus a stellar child you know a stellar student why would you
spend more stellar student rather than the problem
child you’re probably gonna spend more time with the problem child
you know straighten them at straightening them out rather than the
one who’s already doing great so it just makes more sense so as always guys if
you enjoyed this video like it share it subscribe to the channel and metadata
does something great here email us at elite clinical group at gmail.com for
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that so email us there if you are interested alright guys take care