July 2, 2025 • 21 mins
Dr. Michael Koren hosts Brian Achille, the Chief Operating Officer of the Certified Clinical Research Professionals Society (CCRPS). Brian draws a distinction between doing clinical research casually and doing it professionally. The distinction highlights how professional training and attitudes prove to be a benefit to research and the community at large. The duo discuss how CCRPS offers training for many different clinical research roles, from "entry level" to physicians.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Announcer (00:00):
Welcome to MedEvidence, where we help you
navigate the Truth behindmedical research with unbiased,
evidence-proven facts Hosted bycardiologist and top medical
researcher, Dr.
Michael Koren.
Dr. Michael Koren (00:11):
Hello, I'm Dr .
Michael Koren, the executiveeditor of MedEvidence! And I
have a neat guest today, Mr.
Brian Achille, who is somebodywho's dedicated to the clinical
trials industry and also an MBA,and so I'd love to have a
discussion with Brian, with ouraudience, and learn more about
(00:32):
how we got to this really neatrole of being the COO of a
startup company that's involvedin medical education,
specifically with relationshipto the clinical trials industry,
and also learn about whatthey're thinking are next steps
for helping professionalseducate themselves in this field
.
So, Brian, welcome toMedEvidence!
Brian Achille, MBA (00:53):
Thank you for having me, Dr.
Koren, it's a pleasure.
Dr. Michael Koren (00:56):
Yeah, yeah.
So I'm really really excitedabout our conversation.
That's upcoming, andspecifically some of your
thoughts about training.
But before we get to that point, tell the audience a little bit
about your background.
Brian Achille, MBA (01:10):
Will do so, guys.
My name is Brian Achille.
I am a clinical researchprofessional by heart.
I love what I do.
I love to teach.
I got my start back in 2016 ina small independent research
site in Jamaica, Queens, inLaurelton, Queens.
I always mention him, Dr.
Scott, who gave me my training,and he was the person that
(01:32):
really taught me what clinicalresearch is from all aspects and
that's where I really got mystart in the field and I'm happy
to represent CCRPS, which isour new clinical research
company.
It's a leader in clinicalresearch education globally and
happy to talk with you today, Dr.
Koren, about our deliverablesand what we do and our mission.
Dr. Michael Koren (01:53):
That's fabulous and your official title
is Chief Operating Officer.
Brian Achille, MBA (01:58):
That is correct.
Dr. Michael Koren (02:00):
And tell us a little bit about the company,
how long you've been inexistence and how long you've
been in your role.
Brian Achille, MBA (02:04):
So I've been in my role for the last three
months.
I'm fairly new to the role, butnot new to CCRPS, so I actually
graduated from theirpharmacovigilance course in 2019
.
They reached back out to me.
We're a very grassroots company, so a lot of our guys who are
working on the C3 level and areworking from the advisory board
(02:26):
are actually people that weworked with us historically,
have went through our programs,which is very nice.
It's a big blessing.
So our company was officiallystarted in 2016.
This is when the website was putabout, but actually it's very
funny.
So we were actually a pamphlet.
That's how CCRPS started.
(02:48):
It's from Amareen, who's thefounder, and her mother, Kamal,
was teaching her community, herfriends, how to get into
clinical research, so she becamea.
She's a physician from Indiaand she became a clinical
research associate and a lot ofpeople ask you oh, my goodness,
how did you get this position?
It's a very rewarding position.
(03:09):
You're monitoring the newmedications and you're traveling
, and it's a very beautifulposition.
So she made a pamphlet, andthat pamphlet had a lot of buzz
had a lot of value of teachingpeople how to get into clinical
research phase one, phase two,phase three, phase four and then
they decided to make it into awebsite and then that website
(03:30):
started getting some moretraffic and, I guess, fast
forward, you know, 10 years.
We've become a fully functionalcompany, a clinical research
education company, in 2025.
Dr. Michael Koren (03:38):
Very, very cool.
So we're going to break downsome of those terms for the
audience.
Obviously, you and I in theclinical research field know
what you're referring to, butwe're going to break it down a
little bit more.
But getting back to you, so youended up getting an MBA.
Was that before or after youdid your stint with Dr.
Scott?
Brian Achille, MBA (03:58):
So I got my training, first from Dr.
Scott at the Clinical ResearchAssociates, and then that's what
told me to pursue an MBA.
So I currently well, I got myMBA at the George Washington
University School of Businesswith a concentration in clinical
research administration, so itteaches you all the aspects from
all angles, which is exactlywhat I wanted to pursue for
(04:21):
myself.
Dr. Michael Koren (04:22):
That's great, fabulous, all right.
So let's move to some of theterminology that you're using.
So CRA, we understand, is aclinical research associate, and
that's most often used for theclinical research professionals
that are part of the monitoringprocess for our clinical trials,
(04:43):
traditionally hired bypharmaceutical companies or
other medical industries andalso by what's called CROs or
contract research organizations.
So that's one group of people,and then we have another group
that are typically calledresearch coordinators, who are
(05:04):
working in physicians' officesor other entities that are
actually seeing the patients andthen capturing the data and
ultimately getting theinformation from the patients
into a database.
So is your training involvedwith both of these groups?
So break it down a little bitmore for us.
Brian Achille, MBA (05:21):
Yes, so CCRPS, we offer all of that
training.
So we offer training from theresearch assistant all the way
to, as you mentioned, from thepharmaceutical side.
So we do offer that clinicalresearch coordinator experience,
right, and all that jobtraining that's done for those
that are on site, the ones thatare seeing the patients and are
training professionals.
(05:41):
What does your job entail,right?
What database?
You mentioned intaking data,right?
What does that look like?
Data entry, GCP, good clinicalpractice, breaking it down to
that level, and also, if youwant to be a clinical research
associate, you can also.
We also provide that samecourse.
You're able to learn the insand outs of the industry and we
(06:03):
do provide you know, providelots of mentorship and job
support so we can let you knowthis is probably the best way
for your particular skillset.
We do lots of analysis backedby science, right, to see what
could be the best fit foryourself in terms of the
industry and what's out therefor you.
Dr. Michael Koren (06:19):
Yeah, and just for the audience,
understanding GCP good clinicalpractice is super important for
what we do and those are the FDArules on how clinical trials
are conducted.
So, for example, if somebody isin a clinical trial and they
end up in the hospital, what doyou do?
And all that is covered underwhat we call GCP and these are
(06:41):
important obligations foreverybody who's involved in
clinical research.
So it's an important role toeducate people.
So, Brian, tell us a little bitabout the paths of somebody.
Let's say they're a medicalassistant and they want to
advance their career.
They're excited about the ideaof being part of research.
How do they touch you and yourcompany and what's the path and
(07:01):
how much does it cost them?
Brian Achille, MBA (07:04):
Oh, it's a great question.
So they can reach out to us andwe can give them some type of
guidance and, to be honest, Ieven personally respond to some
of the emails.
You get that email.
That's probably our biggestemail.
Hey, I'm interested in clinicalresearch.
Is it for me?
Is it something that I needother education for?
What does the process look like?
And I'm more than happy to goin and provide the same
(07:25):
information that I'm about togiv e.
Essentially, what it is is wewill do that assement, where do
you want to be?
Do you want to be on the site?
Most commonly, clinicalresearch coordinator would be
the best option.
You do learn the most, it's themost.
It's one of the most importantjobs.
You're seeing the patient andyou're really conducting all
(07:45):
aspects of the trial right Allaspects of regulatory, the
financial and the qualityaspects, and it will cost about
$500 to get the course, but wedo also offer packages for job
support and mentorship as well,and we also have live
instructors.
So, as you're conducting yourcourse, you're not just by
yourself.
We have live instructors whoare industry professionals who
(08:08):
are able then to give youguidance on the courses, which
can be completed within fourweeks, but they're self-paced,
so you have all the time in yourroles A lot of our students
have jobs or maybe are in school, so we make it as flexible as
possible.
Dr. Michael Koren (08:24):
Beautiful, beautiful.
And what would the cost be forsomebody that wants to go from a
medical assistant to somebodythat potentially is hireable for
clinical research organizations?
Brian Achille, MBA (08:35):
So for us it's, at the minimum it will be
$500 for our basic package,which is the course and
receiving that certificate thatyou've completed the course, and
then we also have
Dr. Michael Koren (08:47):
That's very, extremely reasonable Wow.
Isn't that a great price.
How do you stay inbusiness at such a low price,
quite frankly?
But that's great, great, keepon going.
And then, what are the nextsteps?
Brian Achille, MBA (08:57):
So the next one would also be for mentorship
.
So I serve as a mentor for thePharmacovigilance Program.
I have mentees who I'm able toteach and to help fast track if
they have questions.
We spend some time together andhelping them with their CV.
So that's about three paymentsof $500 for that package, and
(09:17):
then also we have anotherpackage for $2,500 for job
support as well.
We do have some partners who areworking with us and are going
to be bringing ads for jobs thatcome directly to us and we have
a job board that they areposting their jobs on.
So we are building a fast we'refast tracking a really big
(09:39):
opportunity for anyone.
Dr. Michael Koren (09:41):
Those are extremely reasonable fees, so
obviously for somebody gettinginvolved in this industry can be
a nice career advancement.
I think those are veryreasonable.
Is that the primary source offunding for your company or are
there other sources?
Brian Achille, MBA (09:55):
So that's the primary source is our
courses, the clinical researchcoordinating one is seems to be
our most popular.
It's, you know, again, it's anentry level position, but in my
opinion there's no such thing asan entry level position in
clinical research.
There's so many differentopportunities and it's you know,
I do recommend you do maybe goclinical entry level, called the
(10:16):
CRC route.
But also our CRA position, theClinical Research Associate, the
one that, as you mentioned, isdoing the monitoring at the
different sites, is alsosomething that I think catches
people's eyes most.
Dr. Michael Koren (10:27):
Right, so that's terrific.
So let's transition now tophysicians.
That have been a much toughergroup to get interested in
clinical research training for anumber of reasons we'll explore
.
But why don't you first explainwhat offerings you have for
doctors?
Brian Achille, MBA (10:45):
Right.
So physicians, I believe, arepretty smart people.
We like to say that they'revery intellectual good people.
Dr. Michael Koren (10:52):
Many of them yes.
Brian Achille, MBA (10:54):
Many of them .
Dr. Michael Koren (10:57):
We certainly don't have a monopoly on
intelligence, but thank you forthat kind word.
Brian Achille, MBA (11:01):
You got it, Dr.
Koren.
So you know, one thing that wetry to teach and at least that I
try to teach is the clinicalresearch is very rewarding.
You know, you want to seepeople who may not even have,
let's say, for Sjorgren's theydon't have an option for
treatment and you want to seethem doing better.
And I think most physicians,most people, would want this.
(11:23):
But how do you do it?
And that's where training hasto come in.
So I try to tell you know,physicians, and try to get the
word out there that the trainingis important because without it
you won't really understand theframework, you won't understand
the language, some of theacronyms that are used, and it
will make things a little bitmore challenging in the long run
(11:44):
.
I do see, unfortunately, a lotof physicians have burnout
because of the amount of workand because of the work itself
and not understanding maybecertain responsibilities and
maybe some differences.
So what we provide is anadvanced PI course that will
fast track and get thephysicians on board with what
(12:04):
their job is, keep them up todate on the industry, keep them
up to date on regulations,quality components, how to lead
their team, how to deal withstakeholders and to really give
them that experience of how torun a clinical research site
without necessarily having thatexperience.
Dr. Michael Koren (12:24):
Sure, and what's your charge for that?
Brian Achille, MBA (12:27):
So that one is also $500 for the advanced PI
course.
Dr. Michael Koren (12:32):
Okay, and it could be a challenge to go from
just book learning to actualexecution of your knowledge for
physicians.
Do you help with that at all?
Brian Achille, MBA (12:45):
So we do.
So that will come with livementorship.
We have PIs, we have doctors,and what we try to do is build
off community as well.
So we have a community ofphysicians who are within the
CCRPS community, some graduates,and we try to bring them back
for that mentorship as well.
I've seen from different modelsof PIs needing to constantly
(13:07):
get together to talk about goodpractices.
Hey, this is a problem thatwe're having at my business.
How do you guys solve this?
So that gives a lot of, I think, fast tracking in terms of
alleviating some of the burdenyou would be surprised about, at
least in the industry.
There are certain burdens thatare almost universal, I hate to
(13:29):
say, but if you are aware ofthem and have that education, it
can really help you when youare presently with your patients
and your team.
Dr. Michael Koren (13:41):
Got it, yeah, so there's something called a
CPI, or a Certified PrincipalInvestigator or Primary
Investigator, and that issomething that has been around
for probably about 15, 20 yearsand has, quite honestly, had
difficulty with traction.
I'm a past president of theAcademy of Physicians and
(14:02):
Clinical Research.
I am a CPI.
I took the board exam and I'vetried to use this to leverage my
position a little bit, maybeget a little bit higher payment
from the companies that hire us,but so far that hasn't happened
.
Which is one of the tough partsof this is that you spend the
(14:24):
time and effort becoming anexpert in actually running
clinical trials rather than justan expert in your therapeutic
area, and it doesn't always getacknowledged by the industry.
So I don't know if you've seenthat as a problem or have any
thoughts about that, but I thinkin my experience it's been one
of the reasons that physicianshaven't completely embraced
these additional certifications.
Brian Achille, MBA (14:47):
I think that's a very great point, Dr.
Koren.
I think what we need here isadvocacy for people who are
passionate about clinicalresearch.
I think that we need to seemore PIs.
I do agree with you that thatpassion, um even you know you,
for example, you're taking thetime to speak with me.
We need more PIs who have thatsame passion that you know, that
(15:08):
you show when you're within thecommunities, when you're trying
to learn the needs of thepatient populations and how the
research can help them.
I would agree with you andunfortunately it it will seem
that sometimes with our at leastour audience, sometimes we, we
get the training afterwards.
So I, like I want training tobe a little bit more, more you
(15:31):
know prior, as opposed to oh hey, I'm in a big mess, I need to
clean up, I need to fix it, Ineed to train.
So I do agree with you thatthis is something that needs to
be changed within the community,within the industry, and I'm
also an advocate for more, forrewarding PIs for their work,
for taking it seriously, forlearning you know the PI, for
(15:53):
advancing themselves in clinicalresearch as well.
So definitely something I'veseen in the industry and I'm
hoping to change and we aretotally aligned.
Dr. Michael Koren (16:02):
Yeah, it's a hugely important point, and well
made by you which is that youcan either do this casually when
I say do this, meaning be aprincipal investigator or you
can do it very professionallyand at the end of the day, it's
a huge public health benefit ifwe have more physicians that do
it very professionally, and weneed to get the word out both to
(16:23):
patients and industry thatphysicians who dedicate the time
and effort to becomeprofessional in clinical
research should get the properacknowledgement number one and
compensation for that additionaleffort and training.
So some work to be done, but itsounds like you're one of the
soldiers in that battle, so muchappreciated.
Brian Achille, MBA (16:44):
Well, 100% and I think it's across the
board is with the PI.
You know, and, as you mentioned, you spend time with your
patient population, the patientsas well.
You know when we send overdiaries and are giving patients,
you know I call it quote,unquote homework.
You know, I understand thatit's it's you need that
information and also we want tomake sure that the patients are
doing well and, you know, keepup to date with them.
(17:07):
But it's also a little bit of aburden too, and what we try to
do is help people with theburden, and PIs definitely have
a huge responsibility, and thenumber one thing I hate to see
is oh, you know, the PI isresponsible.
It's a team effort and alsoreward the PI who's going an
extra mile to give you reallygood information checking on the
(17:28):
patient, calling the patients,making sure that their staff is,
you know, calling the patientsmaking sure that they're happy,
making sure that they're, youknow, even their mental health
or wellbeing.
Everything has been taken intoplace into the patient's
experience.
Dr. Michael Koren (17:41):
Yeah, that's a really important point.
We'd like to advocate forresearch as a care option here
at MedEvidence, and you'repointing out that exact point
that a lot of patients, quitefrankly, are frustrated with the
common practice of medicinebecause it's become a little bit
of an assembly line, quitefrankly, as physicians are
(18:02):
pinched for time.
There is a focus more on theelectronic medical record rather
than the patient's needs andpsyche, and that's different,
ironically, in the clinicalresearch setting, where we just
spend more time with thepatients and get to understand
them better and ultimatelyaddress what their needs are,
even outside the protocol.
And so one of the key points ofa good team, including an
(18:27):
educated clinical researchprofessional physician, is that
you understand how to balancethe protocol requirements with
the care requirements ofpatients, and having people
truly understand the ethicalissues that are involved in
research, the scientific issuesthat are involved in research
and the regulatory issuesinvolved in research, not to
mention the fact that you haveto lead a team of other people,
(18:48):
are all part of this trainingthat I think you address in your
modules and that are reallysuper important, not only for
career advancement for thedoctors, but also for good care
in the communities and offeringoptions for patients in the
communities to access this typeof care.
So again, thank you for whatyou do.
Brian Achille, MBA (19:07):
Thank you, thank you, you hit it right on
the nail, that is very importantto me.
I appreciate it.
Dr. Michael Koren (19:13):
So, Brian, any concluding remarks about
your organization and what youhope to accomplish and the
messages you want to get out tothe MedEvidence audience?
Brian Achille, MBA (19:23):
Definitely, guys, thank you for having us.
We're building up a very bigcommunity here at CCRPS.
Some of our testimonials againI always mention clinical
research is for everyone.
If you don't think that you canbe a clinical research person,
trust me you can.
There's different avenues andI'm always happy to speak with
anyone in your community If theyhave any questions.
(19:43):
How can I get into the field?
Different jobs, different jobopportunities.
We have so many you know peoplewho have come back to us and
give us testimonials.
You know, from medicalassistants who got their first
clinical research coordinatingjob to guys who are able to get
into biotech or PIs who are, youknow, able to really stabilize
(20:03):
their sites.
So these type of situationsthat we have, I'm super, super
happy to have them.
You're free to join us at CCRPS.
org.
Take a look at our website andany questions that you have.
You have 24-7 live chat andyou're able to contact us
anytime.
We're a global company.
Just recently I was able tohelp a Nigerian lab.
(20:27):
They're having some issues withsome of the quality aspects and
we gave them that training.
So nothing more I love thansharing information and sharing
knowledge.
Dr. Michael Koren (20:37):
Well, Brian, thank you for the fabulous
information and you've been afabulous guest here at
MedEvidence and I look forwardto working with you in the
future.
Brian Achille, MBA (20:46):
Definitely, Dr.
Koren.
You're welcome to be on board.
Thank you for having me, guys,
Thanks for joining theMedEvidence podcast.
To learn more, head over toMedEvidence.
com or subscribe to our podcaston your favorite podcast
platform.
Welcome to MedEvidence, where we help you
navigate the Truth behindmedical research with unbiased,
evidence-proven facts Hosted bycardiologist and top medical
researcher, Dr.
Michael Koren.
Dr. Michael Koren (00:11):
Hello, I'm Dr .
Michael Koren, the executiveeditor of MedEvidence! And I
have a neat guest today, Mr.
Brian Achille, who is somebodywho's dedicated to the clinical
trials industry and also an MBA,and so I'd love to have a
discussion with Brian, with ouraudience, and learn more about
(00:32):
how we got to this really neatrole of being the COO of a
startup company that's involvedin medical education,
specifically with relationshipto the clinical trials industry,
and also learn about whatthey're thinking are next steps
for helping professionalseducate themselves in this field
.
So, Brian, welcome toMedEvidence!
Brian Achille, MBA (00:53):
Thank you for having me, Dr.
Koren, it's a pleasure.
Dr. Michael Koren (00:56):
Yeah, yeah.
So I'm really really excitedabout our conversation.
That's upcoming, andspecifically some of your
thoughts about training.
But before we get to that point, tell the audience a little bit
about your background.
Brian Achille, MBA (01:10):
Will do so, guys.
My name is Brian Achille.
I am a clinical researchprofessional by heart.
I love what I do.
I love to teach.
I got my start back in 2016 ina small independent research
site in Jamaica, Queens, inLaurelton, Queens.
I always mention him, Dr.
Scott, who gave me my training,and he was the person that
(01:32):
really taught me what clinicalresearch is from all aspects and
that's where I really got mystart in the field and I'm happy
to represent CCRPS, which isour new clinical research
company.
It's a leader in clinicalresearch education globally and
happy to talk with you today, Dr.
Koren, about our deliverablesand what we do and our mission.
Dr. Michael Koren (01:53):
That's fabulous and your official title
is Chief Operating Officer.
Brian Achille, MBA (01:58):
That is correct.
Dr. Michael Koren (02:00):
And tell us a little bit about the company,
how long you've been inexistence and how long you've
been in your role.
Brian Achille, MBA (02:04):
So I've been in my role for the last three
months.
I'm fairly new to the role, butnot new to CCRPS, so I actually
graduated from theirpharmacovigilance course in 2019
.
They reached back out to me.
We're a very grassroots company, so a lot of our guys who are
working on the C3 level and areworking from the advisory board
(02:26):
are actually people that weworked with us historically,
have went through our programs,which is very nice.
It's a big blessing.
So our company was officiallystarted in 2016.
This is when the website was putabout, but actually it's very
funny.
So we were actually a pamphlet.
That's how CCRPS started.
(02:48):
It's from Amareen, who's thefounder, and her mother, Kamal,
was teaching her community, herfriends, how to get into
clinical research, so she becamea.
She's a physician from Indiaand she became a clinical
research associate and a lot ofpeople ask you oh, my goodness,
how did you get this position?
It's a very rewarding position.
(03:09):
You're monitoring the newmedications and you're traveling
, and it's a very beautifulposition.
So she made a pamphlet, andthat pamphlet had a lot of buzz
had a lot of value of teachingpeople how to get into clinical
research phase one, phase two,phase three, phase four and then
they decided to make it into awebsite and then that website
(03:30):
started getting some moretraffic and, I guess, fast
forward, you know, 10 years.
We've become a fully functionalcompany, a clinical research
education company, in 2025.
Dr. Michael Koren (03:38):
Very, very cool.
So we're going to break downsome of those terms for the
audience.
Obviously, you and I in theclinical research field know
what you're referring to, butwe're going to break it down a
little bit more.
But getting back to you, so youended up getting an MBA.
Was that before or after youdid your stint with Dr.
Scott?
Brian Achille, MBA (03:58):
So I got my training, first from Dr.
Scott at the Clinical ResearchAssociates, and then that's what
told me to pursue an MBA.
So I currently well, I got myMBA at the George Washington
University School of Businesswith a concentration in clinical
research administration, so itteaches you all the aspects from
all angles, which is exactlywhat I wanted to pursue for
(04:21):
myself.
Dr. Michael Koren (04:22):
That's great, fabulous, all right.
So let's move to some of theterminology that you're using.
So CRA, we understand, is aclinical research associate, and
that's most often used for theclinical research professionals
that are part of the monitoringprocess for our clinical trials,
(04:43):
traditionally hired bypharmaceutical companies or
other medical industries andalso by what's called CROs or
contract research organizations.
So that's one group of people,and then we have another group
that are typically calledresearch coordinators, who are
(05:04):
working in physicians' officesor other entities that are
actually seeing the patients andthen capturing the data and
ultimately getting theinformation from the patients
into a database.
So is your training involvedwith both of these groups?
So break it down a little bitmore for us.
Brian Achille, MBA (05:21):
Yes, so CCRPS, we offer all of that
training.
So we offer training from theresearch assistant all the way
to, as you mentioned, from thepharmaceutical side.
So we do offer that clinicalresearch coordinator experience,
right, and all that jobtraining that's done for those
that are on site, the ones thatare seeing the patients and are
training professionals.
(05:41):
What does your job entail,right?
What database?
You mentioned intaking data,right?
What does that look like?
Data entry, GCP, good clinicalpractice, breaking it down to
that level, and also, if youwant to be a clinical research
associate, you can also.
We also provide that samecourse.
You're able to learn the insand outs of the industry and we
(06:03):
do provide you know, providelots of mentorship and job
support so we can let you knowthis is probably the best way
for your particular skillset.
We do lots of analysis backedby science, right, to see what
could be the best fit foryourself in terms of the
industry and what's out therefor you.
Dr. Michael Koren (06:19):
Yeah, and just for the audience,
understanding GCP good clinicalpractice is super important for
what we do and those are the FDArules on how clinical trials
are conducted.
So, for example, if somebody isin a clinical trial and they
end up in the hospital, what doyou do?
And all that is covered underwhat we call GCP and these are
(06:41):
important obligations foreverybody who's involved in
clinical research.
So it's an important role toeducate people.
So, Brian, tell us a little bitabout the paths of somebody.
Let's say they're a medicalassistant and they want to
advance their career.
They're excited about the ideaof being part of research.
How do they touch you and yourcompany and what's the path and
(07:01):
how much does it cost them?
Brian Achille, MBA (07:04):
Oh, it's a great question.
So they can reach out to us andwe can give them some type of
guidance and, to be honest, Ieven personally respond to some
of the emails.
You get that email.
That's probably our biggestemail.
Hey, I'm interested in clinicalresearch.
Is it for me?
Is it something that I needother education for?
What does the process look like?
And I'm more than happy to goin and provide the same
(07:25):
information that I'm about togiv e.
Essentially, what it is is wewill do that assement, where do
you want to be?
Do you want to be on the site?
Most commonly, clinicalresearch coordinator would be
the best option.
You do learn the most, it's themost.
It's one of the most importantjobs.
You're seeing the patient andyou're really conducting all
(07:45):
aspects of the trial right Allaspects of regulatory, the
financial and the qualityaspects, and it will cost about
$500 to get the course, but wedo also offer packages for job
support and mentorship as well,and we also have live
instructors.
So, as you're conducting yourcourse, you're not just by
yourself.
We have live instructors whoare industry professionals who
(08:08):
are able then to give youguidance on the courses, which
can be completed within fourweeks, but they're self-paced,
so you have all the time in yourroles A lot of our students
have jobs or maybe are in school, so we make it as flexible as
possible.
Dr. Michael Koren (08:24):
Beautiful, beautiful.
And what would the cost be forsomebody that wants to go from a
medical assistant to somebodythat potentially is hireable for
clinical research organizations?
Brian Achille, MBA (08:35):
So for us it's, at the minimum it will be
$500 for our basic package,which is the course and
receiving that certificate thatyou've completed the course, and
then we also have
Dr. Michael Koren (08:47):
That's very, extremely reasonable Wow.
Isn't that a great price.
How do you stay inbusiness at such a low price,
quite frankly?
But that's great, great, keepon going.
And then, what are the nextsteps?
Brian Achille, MBA (08:57):
So the next one would also be for mentorship
.
So I serve as a mentor for thePharmacovigilance Program.
I have mentees who I'm able toteach and to help fast track if
they have questions.
We spend some time together andhelping them with their CV.
So that's about three paymentsof $500 for that package, and
(09:17):
then also we have anotherpackage for $2,500 for job
support as well.
We do have some partners who areworking with us and are going
to be bringing ads for jobs thatcome directly to us and we have
a job board that they areposting their jobs on.
So we are building a fast we'refast tracking a really big
(09:39):
opportunity for anyone.
Dr. Michael Koren (09:41):
Those are extremely reasonable fees, so
obviously for somebody gettinginvolved in this industry can be
a nice career advancement.
I think those are veryreasonable.
Is that the primary source offunding for your company or are
there other sources?
Brian Achille, MBA (09:55):
So that's the primary source is our
courses, the clinical researchcoordinating one is seems to be
our most popular.
It's, you know, again, it's anentry level position, but in my
opinion there's no such thing asan entry level position in
clinical research.
There's so many differentopportunities and it's you know,
I do recommend you do maybe goclinical entry level, called the
(10:16):
CRC route.
But also our CRA position, theClinical Research Associate, the
one that, as you mentioned, isdoing the monitoring at the
different sites, is alsosomething that I think catches
people's eyes most.
Dr. Michael Koren (10:27):
Right, so that's terrific.
So let's transition now tophysicians.
That have been a much toughergroup to get interested in
clinical research training for anumber of reasons we'll explore
.
But why don't you first explainwhat offerings you have for
doctors?
Brian Achille, MBA (10:45):
Right.
So physicians, I believe, arepretty smart people.
We like to say that they'revery intellectual good people.
Dr. Michael Koren (10:52):
Many of them yes.
Brian Achille, MBA (10:54):
Many of them .
Dr. Michael Koren (10:57):
We certainly don't have a monopoly on
intelligence, but thank you forthat kind word.
Brian Achille, MBA (11:01):
You got it, Dr.
Koren.
So you know, one thing that wetry to teach and at least that I
try to teach is the clinicalresearch is very rewarding.
You know, you want to seepeople who may not even have,
let's say, for Sjorgren's theydon't have an option for
treatment and you want to seethem doing better.
And I think most physicians,most people, would want this.
(11:23):
But how do you do it?
And that's where training hasto come in.
So I try to tell you know,physicians, and try to get the
word out there that the trainingis important because without it
you won't really understand theframework, you won't understand
the language, some of theacronyms that are used, and it
will make things a little bitmore challenging in the long run
(11:44):
.
I do see, unfortunately, a lotof physicians have burnout
because of the amount of workand because of the work itself
and not understanding maybecertain responsibilities and
maybe some differences.
So what we provide is anadvanced PI course that will
fast track and get thephysicians on board with what
(12:04):
their job is, keep them up todate on the industry, keep them
up to date on regulations,quality components, how to lead
their team, how to deal withstakeholders and to really give
them that experience of how torun a clinical research site
without necessarily having thatexperience.
Dr. Michael Koren (12:24):
Sure, and what's your charge for that?
Brian Achille, MBA (12:27):
So that one is also $500 for the advanced PI
course.
Dr. Michael Koren (12:32):
Okay, and it could be a challenge to go from
just book learning to actualexecution of your knowledge for
physicians.
Do you help with that at all?
Brian Achille, MBA (12:45):
So we do.
So that will come with livementorship.
We have PIs, we have doctors,and what we try to do is build
off community as well.
So we have a community ofphysicians who are within the
CCRPS community, some graduates,and we try to bring them back
for that mentorship as well.
I've seen from different modelsof PIs needing to constantly
(13:07):
get together to talk about goodpractices.
Hey, this is a problem thatwe're having at my business.
How do you guys solve this?
So that gives a lot of, I think, fast tracking in terms of
alleviating some of the burdenyou would be surprised about, at
least in the industry.
There are certain burdens thatare almost universal, I hate to
(13:29):
say, but if you are aware ofthem and have that education, it
can really help you when youare presently with your patients
and your team.
Dr. Michael Koren (13:41):
Got it, yeah, so there's something called a
CPI, or a Certified PrincipalInvestigator or Primary
Investigator, and that issomething that has been around
for probably about 15, 20 yearsand has, quite honestly, had
difficulty with traction.
I'm a past president of theAcademy of Physicians and
(14:02):
Clinical Research.
I am a CPI.
I took the board exam and I'vetried to use this to leverage my
position a little bit, maybeget a little bit higher payment
from the companies that hire us,but so far that hasn't happened
.
Which is one of the tough partsof this is that you spend the
(14:24):
time and effort becoming anexpert in actually running
clinical trials rather than justan expert in your therapeutic
area, and it doesn't always getacknowledged by the industry.
So I don't know if you've seenthat as a problem or have any
thoughts about that, but I thinkin my experience it's been one
of the reasons that physicianshaven't completely embraced
these additional certifications.
Brian Achille, MBA (14:47):
I think that's a very great point, Dr.
Koren.
I think what we need here isadvocacy for people who are
passionate about clinicalresearch.
I think that we need to seemore PIs.
I do agree with you that thatpassion, um even you know you,
for example, you're taking thetime to speak with me.
We need more PIs who have thatsame passion that you know, that
(15:08):
you show when you're within thecommunities, when you're trying
to learn the needs of thepatient populations and how the
research can help them.
I would agree with you andunfortunately it it will seem
that sometimes with our at leastour audience, sometimes we, we
get the training afterwards.
So I, like I want training tobe a little bit more, more you
(15:31):
know prior, as opposed to oh hey, I'm in a big mess, I need to
clean up, I need to fix it, Ineed to train.
So I do agree with you thatthis is something that needs to
be changed within the community,within the industry, and I'm
also an advocate for more, forrewarding PIs for their work,
for taking it seriously, forlearning you know the PI, for
(15:53):
advancing themselves in clinicalresearch as well.
So definitely something I'veseen in the industry and I'm
hoping to change and we aretotally aligned.
Dr. Michael Koren (16:02):
Yeah, it's a hugely important point, and well
made by you which is that youcan either do this casually when
I say do this, meaning be aprincipal investigator or you
can do it very professionallyand at the end of the day, it's
a huge public health benefit ifwe have more physicians that do
it very professionally, and weneed to get the word out both to
(16:23):
patients and industry thatphysicians who dedicate the time
and effort to becomeprofessional in clinical
research should get the properacknowledgement number one and
compensation for that additionaleffort and training.
So some work to be done, but itsounds like you're one of the
soldiers in that battle, so muchappreciated.
Brian Achille, MBA (16:44):
Well, 100% and I think it's across the
board is with the PI.
You know, and, as you mentioned, you spend time with your
patient population, the patientsas well.
You know when we send overdiaries and are giving patients,
you know I call it quote,unquote homework.
You know, I understand thatit's it's you need that
information and also we want tomake sure that the patients are
doing well and, you know, keepup to date with them.
(17:07):
But it's also a little bit of aburden too, and what we try to
do is help people with theburden, and PIs definitely have
a huge responsibility, and thenumber one thing I hate to see
is oh, you know, the PI isresponsible.
It's a team effort and alsoreward the PI who's going an
extra mile to give you reallygood information checking on the
(17:28):
patient, calling the patients,making sure that their staff is,
you know, calling the patientsmaking sure that they're happy,
making sure that they're, youknow, even their mental health
or wellbeing.
Everything has been taken intoplace into the patient's
experience.
Dr. Michael Koren (17:41):
Yeah, that's a really important point.
We'd like to advocate forresearch as a care option here
at MedEvidence, and you'repointing out that exact point
that a lot of patients, quitefrankly, are frustrated with the
common practice of medicinebecause it's become a little bit
of an assembly line, quitefrankly, as physicians are
(18:02):
pinched for time.
There is a focus more on theelectronic medical record rather
than the patient's needs andpsyche, and that's different,
ironically, in the clinicalresearch setting, where we just
spend more time with thepatients and get to understand
them better and ultimatelyaddress what their needs are,
even outside the protocol.
And so one of the key points ofa good team, including an
(18:27):
educated clinical researchprofessional physician, is that
you understand how to balancethe protocol requirements with
the care requirements ofpatients, and having people
truly understand the ethicalissues that are involved in
research, the scientific issuesthat are involved in research
and the regulatory issuesinvolved in research, not to
mention the fact that you haveto lead a team of other people,
(18:48):
are all part of this trainingthat I think you address in your
modules and that are reallysuper important, not only for
career advancement for thedoctors, but also for good care
in the communities and offeringoptions for patients in the
communities to access this typeof care.
So again, thank you for whatyou do.
Brian Achille, MBA (19:07):
Thank you, thank you, you hit it right on
the nail, that is very importantto me.
I appreciate it.
Dr. Michael Koren (19:13):
So, Brian, any concluding remarks about
your organization and what youhope to accomplish and the
messages you want to get out tothe MedEvidence audience?
Brian Achille, MBA (19:23):
Definitely, guys, thank you for having us.
We're building up a very bigcommunity here at CCRPS.
Some of our testimonials againI always mention clinical
research is for everyone.
If you don't think that you canbe a clinical research person,
trust me you can.
There's different avenues andI'm always happy to speak with
anyone in your community If theyhave any questions.
(19:43):
How can I get into the field?
Different jobs, different jobopportunities.
We have so many you know peoplewho have come back to us and
give us testimonials.
You know, from medicalassistants who got their first
clinical research coordinatingjob to guys who are able to get
into biotech or PIs who are, youknow, able to really stabilize
(20:03):
their sites.
So these type of situationsthat we have, I'm super, super
happy to have them.
You're free to join us at CCRPS.
org.
Take a look at our website andany questions that you have.
You have 24-7 live chat andyou're able to contact us
anytime.
We're a global company.
Just recently I was able tohelp a Nigerian lab.
(20:27):
They're having some issues withsome of the quality aspects and
we gave them that training.
So nothing more I love thansharing information and sharing
knowledge.
Dr. Michael Koren (20:37):
Well, Brian, thank you for the fabulous
information and you've been afabulous guest here at
MedEvidence and I look forwardto working with you in the
future.
Brian Achille, MBA (20:46):
Definitely, Dr.
Koren.
You're welcome to be on board.
Thank you for having me, guys,
Thanks for joining theMedEvidence podcast.
To learn more, head over toMedEvidence.
com or subscribe to our podcaston your favorite podcast
platform.
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