hey guys ECR G here back with another episode as you can see by the title of
today's episode is about covin 19 once again it's covin 19 accelerating the
demise of the CRA so the topic of this episode was sparked by someone who
reached out to me via email or text one of the other four you know they you can
ask questions if you're just into having your question answered Ali clinical
group at gmail.com I'm also if you interested in resume
reviews or any type of prep to get into the in clinical research industry elite
clinical group at gmail.com where there's been a big increase in people
that have been reaching out to have their resumes looked at and interview
prep just because a lot of people are at home have more time and are looking for
that next jump post corona so let's go to get into the to the nitty-gritty of
this episode so this person emailed in they said hey so I had an internal
meeting at my CRO and my CEO thinks that monitors will no longer exist and I will
probably in that we will probably be doing risk based monitoring do you think
this can happen so there's a lot of misconceptions just off of this question
alone so so for one the CEO saying that monitors will no longer exist what kind
of time frame are they talking are they talking right now they talking right
after coronavirus in a couple months are they talking you know in this video this
episode is created on April 8th just so you guys know this is recorded
on April 8th so are they talking you know in a couple months we're talking
May June we're serious arrays aren't gonna exist are they talking you know in
a few years so I do think that obviously no CRA aren't going anywhere right now
today next month in two months but there are going to be some changes from
coronavirus and a lot of people are experiencing them where CRA s are not
travelling which is the big which is a huge part of the job being able to
travel and go on site and make sure things are being run accordingly on site
and if people are you know getting used to working remotely they're getting the
infrastructure built up to work remotely companies are forced because a lot of
companies were scared to have people work remotely and to and they and I
think a lot of companies are seeing just how I don't just how great people
actually work from home and how much people actually enjoy it
when they're working remotely you have to deal with traffic you have to deal
with the headaches of the traffic cuts a lot of commute time reduces the wear and
tear in your car less gas you need to get around just a lot more freedom can
actually work more hours because you don't have to commute time so there's a
whole lot of benefits I've done countless episodes on this you can go
check them out so yeah I mean and and then the second thing that they talk
about is the risk based monitoring so risk based monitoring is a type of
monitoring it combines remote monitoring it combines yes traditional monitoring
where monitors go on-site and review data they're add as a component of risk
based monitoring and it combines other tools that you can do to assess the risk
of certain data points across the study in aspect and at particular sites
because different sites have different capabilities but you can assess the
risks of different data points at these different sites and determine what of
these data points needs to be monitored so before I was a CRA
understanding risk based monitoring you know it didn't quite make complete sense
but after I've been a seer a for a while now it makes sense there's different
data point you know each data point blood pressure height weight these are
data points so risk based monitoring is essentially you know those are data
points among others but risk based monitoring is essentially saying okay
this data point is important to monitor so the height may be at this visit you
know say like a you know a week 12 visit may be that data point of height is not
is not and does not need to be verified at that visit for example most people
don't change height over the course of weeks or months so maybe you only need
to look at height at the randomization visit and never again for the rest of
so that's an example of risk based monitoring where you are assessing the
risk of each data point and determining at what time these data points need to
be monitored that's all it is so it's combining traditional monitoring
yes monitors will still go on site why because monitors role is not just to
you know is not just to mess around on site there's important roles that stuff
that you cannot replicate one relationship with PII relationship with
study staff that is improved when you're going face to face it just is - fraud
monitor one of the main roles of a monitor is detect fraud so if someone's
coming they're looking through your documents in person it's a lot easier to
detect fraud than remotely when so many things can be photoshopped edited marked
out crossed things of that nature so you know risk-based monitoring and remote
monitoring are not going to completely eradicate the CRA completely that is
that is completely in patently false and the next thing you know I guess this
person is worried about is their CEO well the CEO can obviously make changes
to their company and at a moment's notice so they could say you know what
we're going risk based monitoring we're gonna decrease our CRA s they can make
that change instantaneously but that's not that the industry is not going to do
that instantaneously that's one company that's one CRO and
guess what guess who pays for the CRO guess who's the number one client of a
CRO sponsors so sponsors say we want traditional monitoring we don't like
ERISA based monitoring guess what the CRO is gonna do they're gonna do
whatever the sponsor tells them to do so and including that person CEO now the
CEO can then go and say you know what I only want to work with sponsors that I
want to do risk-based monitoring we're going to double down on our risk based
monitoring capabilities so we're only going to work with people that want
risk-based monitoring that's fine there are other CEOs that are going to do the
opposite there are other CEOs that are going to continue to do traditional
monitoring and other sponsors are going to want to continue to do traditional
monitoring so you know that's that but even with
risk based monitoring doing 100% risk based monitoring the CRA is still a
vital vital piece now a CRA is going to be able to manage more sites maybe the
CRA is gonna be both the remote monitor and the on-site monitor and be able to
manage more sites that way but the CRA is not going to go away the series role
just gonna change a little bit differently that's all that's going to
happen as far as I can see now if you're trying to get rid of the monitor
altogether there's probably some software that can do it but still
someone's gonna have to do IP accountability if there's gonna be a lot
of innovation that's going to go on in in the industry to really eradicate the
CRA altogether which is not going to happen for five years or longer probably
ever really and that may sound ridiculous ECR gee how can you say
something's not going to happen forever it's because this industry takes a long
time to phase things out so as a lot of you guys know who've been listening to
the channel I went to East a CRP for the first time in 2019 that was actually a
year ago today April 20 19 I went and they had all these different technology
their East source documents ie ISF documents were software peak packages
you know you can store all your iossef binders on on the internet and things of
that nature look they've had this technology for
years and still most sites are not using it
so you can just kind of see you know in in the site's they're trickled down from
the CRO the CRO will tell the site's ok you need to keep it paper you need to do
this you need to do that and then the CRO is taking their direction from the
sponsors so if the sponsors don't want stuff store electronically guess what
the site's not gonna store electronically if you want that study to
you know a lot of sites may say you know what that's just our policy if you want
to work with us and you have more pull if you're like a Mayo Clinic if you're
one of the Cleveland Clinic if you're one of these huge site networks that
does tons and tons of research you can say you
that's our policy if you don't want to work with us you don't have to work with
us they can say that but it just goes to show that so much technology is out
there but it's not being adapted by the industry because industry change
happened slow innovation happens fast but changed to adopt industry-wide have
been slow so that's just something to keep in mind to say like all these
platforms I could potentially mitigate the series role decrease in number of
hours it takes to them to do stuff it's it's a long time for it to be adopted in
this industry this industry is very very conservative and moves very very slow
when it comes to that so some of the changes I do see happening for COAS and
people that work with CRA is is the increase of remote work I think like
I've mentioned this before my other episodes I do think people are going to
realize that they can work remotely that they can do more remotely that they
actually like working remotely so I do think we'll see policies change
depending on how long this takes I mean it's April 8th today it's April 8th
today let's say this coronavirus stuff goes on until end of June that's a long
time that's March April May June that's four that's four months where people
been working completely from home you know why would they want to go back in
the office again after you've worked so long from home so I think people are
gonna be more apt to want to work from home in hence your remote monitors your
remote monitoring team you're in how CRA s they go to work from home they've been
able to work from home it's not a job where you need to go into the office a
lot of the other jobs clinical trial assistant another one you can do that
job from home you'll need to go into the office for that you can do a lot of
these jobs from home honestly because most people they're just going in the
office and getting on a computer you know we already are using phone Skype
zoom these other things to conduct meetings and things of that nature so
you know I do think there's going to be an emphasis on working for
home another thing that we should see changed is a lot of studies do not have
an in-house CRA or a remote CRA or you know kind of a remote liaison on the
clinical side I think we'll start seeing that more why one because if the CRA
can't go on on-site and travel you're gonna want someone that is
remotely in touch with the site especially the CRO level because they
like to separate the CRA from the in-house CRA and they don't work as
closely together I think as they should at a lot of places at least of course
it's not true of everywhere but they're gonna they're gonna want to have a
steady person and that's that in-house CRA so I think we'll definitely see more
of that let me see what else yeah I just I just don't see monitor I don't see
coronavirus accelerating the demise of Clinical Research Associates I just
don't see that happening I in fact I know for a fact was gonna
happen is as soon as corner virus is over every single site is gonna get
bombarded with monitoring business requests for immediately literally
immediately if corner virus if they say we can you know go up back out after
Friday expect some monitors wanting to come out to that site on that Monday
it's gonna be that fast or that Tuesday it's gonna be that fast so I know we'll
see that and we're gonna get right back into the thick of things you know moving
and grooving doing our traditional monitoring now I think for the future I
think people are gonna remember this or studies that are coming up this year or
protocols that are being written this year I think we're gonna see a
contingency plan a remote monitoring contingency plan if something like this
were to happen again or they'll automatically just build it into the
monitoring of the protocol where you know monitoring visits are gonna be
conducted instead of every six weeks maybe we'll do every 12 weeks and we'll
have remote monitoring visits in between which already is a is a kind of a
risk-based monitoring approach anyway but I do not see the on-site monitoring
visit going anywhere anytime soon as I just don't and if if that call were to
come it has to be called it has to be a call from the sponsors if you have any
questions about coronavirus or use any questions in general you know me alley
clinical group at gmail.com once again elite clinical group at Jimmer calm
alright guys take care