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Rodney Lemery : My name is Rodney Lemery and I am the head of the global pharmacovigilance
and safety group at BioPharm Systems and I'd like to welcome you to what I hope is an exciting
webinar on Oracle's Empirica Topics Software and how to use that software to document your
internal signal management process. In fact what you will see in later slides is that
BioPharm has interpreted the CIOMS VIII report on signal management topics and configured
the Oracle tool to allow a seamless and well documented, or at least what we believe as
one, the method of tracking your signals and how you prioritize and evaluate them.
This is just a high level agenda of what we will cover today. I would like first begin
by summarizing the CIOMS VII suggestions. Use that and other works that are in literature
to create some standard definitions for our discussion today and then I will demonstrate
using slides the Empiric Suite from Oracle . We will not spend a great deal of time on
the signal detection mechanisms of Oracle's products, that is the e-signal tool. Once
the signal is detected we will look at the Accel-tracker solution and specifically spend
time on the prioritization and evaluation of that signal and how Accel-tracker might
assist you in well documenting that method within your organization.
So let's begin by looking at the CIOMS VIII working groups and their summary report from
their publication in 2010. For those of you who haven't read this diagram basically comes
from that report and you can see in it the complicated steps that they themselves, the
CIOMS working group VIII have decided are encompassing of a well thought out signal
management process. We'll start at the top. Everything begins with our individual case
safety reporting. This may be from clinical trial data, post marketing surveillance data,
the systems involved in either of those and literature reviews. Once those individual
case safety reports are received by our organization, then we can perform rudimentary signal detection
as we will discuss signal detection can fall under two broad categories, according to the
CIOMS VIII working group and other I should mention. The first would be your traditional
pharmacovigilance methods. These are the methods that probably most of us are familiar with.
The individual case reviews that are performed in your companies, the individual case series
reviews that might be performed in your company. Any of your aggregate analyses such as the
PSUR report or custom or configured listings or tabulations that you may routinely review.
These items all are what CIOMS VIII and others categorize as traditional pharmacovigilance
methods. Once the repository becomes large enough,
or you identify a software that can handle smaller sample populations to appropriately
calculate statistics, you may use data-mining algorithms, according to CIOMS and this traditional
surfaces as the disproportionality scores that worked some of us might be familiar with
such as PRR's or EBGM's. These four boxes in the ''CIOMS'' VIII working group report
I think capsulated together to represent others the first steps of a signal management process
which we will refer to as signal detection. Once you have detected a signal, then ''CIOMS''
and others suggest that it is important to prioritize those signals so that the appropriate
resources are spent on the appropriate signals. I will not cover the individual boxes below
I will just let you read those at your leisure and I will identify them as signal prioritization.
Finally, we have the formal signal evaluation, which is the comprehensive look at the signal
and any supporting documentation that can actually confirm or refute that signal. So
in summary, the ''CIOMS'' working group, if I can be so bold as to simplify it, can be
simplified and reduced down to three major steps demonstrated by this diagram. So the
first is signal detection followed by signal prioritization and ultimately ending up in
signal evaluation. Now this process could in fact be cyclical in that there are or will
be a number of signals that you may need additional information on before completing the prioritization
or evaluation process. As for the definitions, for the purpose of
this webinar, we want to define these aspects of signal management in a clear mechanism
and manner. So the first is signal detection, and I would like to define this for the purpose
of this discussion only as the act of looking for and or identifying signals using event
data from any source. As we will see in a moment, the tool that we will be using in
the example to detect the signal is in fact the Oracle Empirica signal tool, and we will
be specifically looking at the FDA Errors Database. Signal prioritization will be defined
as the controversial act of applying plausability criteria to identified signals in order to
place the signal in context in order to apply the appropriate resources. And I took this
from ''Waller'', who has a very comprehensive but succinct textbook available that is referenced
in the slides in a number of places and I do highly suggest it as a reading. The last
would be our signal evaluation step and this will be referred to as the act of formally
gathering additional data to evaluate the identified signal for the specific purpose
of feeding it into a risk management process. From our vantage point, in working with a
number of cross-industry companies and client base, being medical device, biotechnology,
pharmaceuticals, both farm and development and generic, we seem to see the following
needs arise when we are talking about signal management itself, and this would be all of the business rules surrounding the
management of a signal. This would include the ability to clearly identify potential
issues or events in both our clinical and our post-marketing data, as well as the ability
to prioritize these signals using a set of standard questions that are part of the existing
literature and ''CIOMS'' VIII working group report. The same would be true for our evaluation
methods. We would like a set of clear questions whenever possible that could allow us to formally
evaluate our signals in a consistent manner and therefore ensure that we are only feeding
those signals into our risk management process that in fact require such evaluation. And
it will also probably be nice if we could predefine a workflow surrounding all of these
business processes. This will empower us to have certain segments of the population in
our safety teams providing the information for signal identification, which is a skill
set that is somewhat different, than those individuals who might be prioritizing or evaluating
the information from a medical or clinical perspective.
Again, I make an assumption there, that we are using data mining algorithms, which are
highly statistical and do require somewhat of a background in epidemiology or Biostatistics
in general, or at least the cross training. The second item that we see apart from the
business processes, is the actually system to collect and track this information. So
this would include something that would allow us to document and identify all of our prioritization
questions and responses, our evaluation question and responses and also allow us to attach
to these signals and their their management any external documentation that can support
these decisions in a standard way.
And finally this system should also be capable of producing an audit report for answering
any kinds of justification for why certain signals became risks and certain signals were
refuted. This would document our due diligence as safety professionals.
So what we have done as a company BioPharm in partnership with Oracle is use the Empirica
Suite which includes among other things the E-signal for signal identification and the
E-topics which would include at least in our opinion the other two parts of signal management
which are signal prioritization and signal evaluation as the tool to figure according
to the CIOMS Working Group and a series decision support article from the existing literature
and textbooks.
So we have taken all of that information, digested it, and come up with a standard workflow
to process these signals and standard questions and answers in order to appropriately prioritize
and evaluate all of these signals that may be elevated uh to the Topics tool. Which again
once fully configured, we are calling a cell tracker.
So in the following slides, I am going to take this opportunity to walk us through a
practical example of signal management. And we will be starting with signal identification.
But keep in mind that the point of this webinar is to specifically focus on the E-Topics tool
and not the E-Signal tool. So while I have a few slides on E-Signal, I will not be focusing
the duration of the discussion on those slides.
So in order to give us some background to this, we do need to understand where BioPharm
originated the questions that you will see on the screen in both the prioritization and
the evaluation area. And as I said on the previous slide the existing literature predominately
the Journal of Drug Safety as well as The Pharmaco-epidemiology and Drug Safety among
other journals, have a number of articles on decision support, which is the construct
in health information systems, of systems that can programmatically be configured to
automate the signal prioritization and evaluation according to percentages of importance for
various categories.
Now, currently, in its current release, E-Topics cannot do this. This is more of a manual evaluation
than an automated one. Nonetheless, I would still argue that E-Topics can be used as a
decision support system in the capacity of um signal prioritization and evaluation. And
again, I think hopefully, these aspects of the discussion become clearer as we go through
the slides.
So again, the first step in our signal management will be the signal detection. We will use
the Empirica Signal Tool. And what tools such as this are really allowing us to do is ensure
a focus on appropriate signals. I used a a quote here that I found in one of the the
articles that I used as a basis for these slides, "That tools such as this if not prioritized
appropriately, will end up finding hay in the hay stack." And I think that this is an
important note we will see in later slides, that if you do not prioritize your signals
appropriately, you could end up spending time, energy and money going down paths that are
not signals at all.
So, in the following slides, what we want to do is assume is we are marketing authorization
holder for a US marketed product of Risedronate or risedronic acid. This is a disphosphonate,
and it's used in treatment of degenerative bone disease. The mechanism of action is both
strengthening bone as well as inhibiting bone re-absorption. It has been approved on the
market since 199VIII in March, under the trade name of Actonel.
So what we would like to do is establish an FDA query in the E-signal tool, which is part
of the Empirica Suite, to identify hotspots of the MedDRA dictionary levels. Namely the
system organ class. If we look at the potential hot spots for this particular product in the
FDA erase data base, we can see that there are a number of hotspots identified in what
Oracle calls their sector map. I'm going to focus on this hotspot within the surgical
and medical procedure sock because it's it's a little striking. When we look at that, we
can see that it's a tooth extraction um and we may be interested in this lets say. We
can also see the standard disproportionality scores for this instance of the term. So here
we are going to say that we have a potential signal for tooth extraction.
The next step in our process will be to take that potential signal, and prioritize it.
And why do we prioritize? Again, we're going to prioritize to hopefully going to prioritize
to screen out the hay in the haystack and only get to the needles. So for example, if
this is a known issue with the product, and it may be well documented in either internal
or external resources. This is an expected event, let's say, or a well-established safety
profile which includes this event. Then we probably do not need to spend time on our
resources working up that particular signal.
We also in our area of clinical research and in epidemiologic investigation, have to worry
about confounding by indication. And these would become morbidities or complications
that might be due to the natural disease progression of the disease, disease state itself, which
could also be related to the treatment population with or without regard to the product of interest.
So confounding by indication is something we would also want to prioritize so that we
could more appropriately distribute our internal resources to the management of this potential
signal. Again, I think stated this multiple times, but I will say one more, the purpose
of prioritization is to really ensure that the appropriate allocation of time, energy
and money is spent on those signals are likely to be true problems in our patient population
or in this case to the greater public health.
Okay, so where do we begin in this process of signal management, namely signal prioritization?
Well this is quite a controversial procedure. And there are very divergent methods in both
the literature and specifically in the CIOMS VII Working Group. So to begin with, the,
the WHO Organization does uses methods similar to emergency rooms triage processes in hospitals
to quickly evaluate aspects of the case that might be more critical for their research,
while placing other cases on, in a holding pattern until a uh additional investigation
periods are over.
TMHRA with Great Britain uses analytical methods comprised of two, primarily two, mathematical
scores, which will then contribute to an overall final score um that will prioritize the case.
There are additional other articles that exist in the literature that would provide valid,
and well at least according to their literature results, valid decision support manners.
With the cell tracker tool, we have taken E-Topics, again as the basic software and
created our accelerator that allows the company to fully document the signal prioritization
and evaluation methods within their organization. And again in the initial release of the cell
tracker, this is in with our interpretation of CIOMS VIII Working Group. And again series
of decision support articles that I myself have um reviewed. I should also mention that
the E-Topics tool is highly configurable and very flexible. So it is really not difficult
to configure the basic Accel-Tracker cell tracker tool to accommodate any specific internal
methods of signal prioritization or evaluation that your company might utilize.
So again, we have identified our signal as tooth extraction, and now we are going to
create what is referred to as a topic in the E-Topics tool that marks the documentation
of this potential signal. We will flow that signal through a workflow and this is the
diagram of the configured work flow we have built in the Accel-Tracker tracker tool and
it does hopefully, at least in my opinion, mirror the recommended processing of the signal
according to CIOMS VIII. And I won't go into great detail here, the slides will show you
these. So, again, once our signal is identified,
we are going to place it in the initial work flow step called signal prioritization in
our cell tracker system. This is going to allow us to complete a series of categorizations
that will eventually flow to an evaluation method to formally document just how important
the signal might be to our internal organization.
This is the initial screen that we have configured in the E-Topics tool. You can see that I can
give my topic a name, my signal a name. I can describe it fully and then this is the
workflow that we have previously identified through the work flow diagram above. Right
now our current state begins with signal prioritization. You can have a series of keywords to allow
you the ability to query on a repository of prioritized or evaluated signals or ultimately
risks within the topics tool.
Here in the prioritization section, I have taken all of the CIOMS VIII and literature
that I have read and basically reduced that to two simplistic questions: Is the signal
expect or unexpected and is there confounding by indication? How likely is that? These two,
what I have seen in some of the literature, are two important questions that will quickly
allow us to identify new experience signals, so unexpected events, and events that are
clearly not confounded by indication. Which means that they are more likely to receive
our attention than others. So, in this example, I do a final signal priority of medium, because
of the mixed message here.
Sorry, clicked too much. Additionally, I could for example attach an external document to
this topic. In this case, it will be the package insert for Actonel, which lead me to answer
the expected question in the manner that I answered. This way all of my information that
I used to support my signal prioritization decision is actually attached to one single
in my Accel-Tracker tool or E-Topics system.
Once that is done, I move the signal from prioritization to signal evaluation and I
am presented with an additional section of questions to answer. These are questions that
we've based again on the CIOMS VIII report and group of research articles in the literature.
And basically, as I stated in a previous slide, it follows a Smith mechanism. So let's just
go back. So Smith would be the strength of your signal, the novelty of your signal, the
clinical importance of your signal and the potential or existence for prevention techniques
for that signal. So these things are all aspects of a signal that are, or should, at least
according to the literature, ring important to your organization in ultimately evaluating
if you have a risk or not.
Here you can see the section for strength evaluation. There's a series of questions
that will build ultimately to a single response of how strong is this signal. Is it strong,
weak or not appropriate in this case? In VIII, I have used, if I need information required.
Notice that the red asterisk is present only on the summary questions for each section
and that means it's required for this workflow step, but none of the other questions are.
Um, here you can see some identified questions for novelty. These could significantly change
depending on what statistical calculations your team uses to address how new a potential
signal is to your organization. We also have importance, um clinical importance. This would
be concepts like, is it an under targeted medical surveillance from a regulatory authority,
from your internal legal department because of the class-action lawsuit for example. Or
is it a public interest in the term? Has there been a lot of media attention on this particular
problem? And this could all, these questions could all go to your qualitative assessment.
As to how important this signal should be seen, in terms of your, uh organization. Are
prevention possibilities, are they already available, are they possible or are they really
kind of impossible to prevent? And all of these will eventually lead to a final signal
evaluation that is clearly documented within the Accel-Tracker tracker tool
Again one of the options of the Empirica Topics tool is to add action to these signals, these
topics. What you can do, in this example, is I need a clinician to review the case series
that make up the 61 cases I think of this original signal. And I would like a clinical
review to confirm such questions as evidence of rechallenge, evidence of the challenge.
This information can only come from a case series review. So in this example, I've added
a topic action and assigned it to my colleague Scott Miller, who should plan on performing
a formal case review prior to the 21st of March.
In this example, we can go back into our E-Signal tool, locate our sector that was hot, and
drill down into the case series. Once, so this is what I have done here, is I have drilled
down to the case series itself and then, as you can see it displays all of the 69 records
that make up this statistical anomaly in our data.
I can then take and save this case series directly to the action of case series review.
That way, my case series will always be a part of my formal prioritization and evaluation
of the tooth extraction signal that we've seen in the data. So this is a very nice uh
systematic, again , way of documenting our procedures around signal prioritization and
evaluation.
I might also have journal articles, or queries, against an epidemiological database of, in
this case let's say elderly patients because this is typically the patient population that
a bisphosphonate for osteoporosis. And I found an example of an article that links bisphosphonate
intake to osteonecrosis of the jaw. Which one could argue is a clinical disease state
that would be remedied by the surgical/medical procedure of tooth extraction. So in this
example, we can see that potentially there may be a class effect of this product to the
identified signal. And again, there would be an evaluation question that indicated whether
or not there is a known or anticipated class effect of this product.
So after all of our research is collected on that signal, we can use the tracker tool
and the E-Topics tool itself, to document all of the results of the evaluation. And
then finally, pass the confirmed signals, or verified signals onto our risk management
workflow. And this can be part of, as it is in the Accel-Tracker tracker tool, of your
signal management procedure. Or, or using E-Topics, you can have a completely different
workflow team responsible for the risk management portion of the signal management process.
So again, if we have a verified or confirmed signal that we want to move into a potential
risk category, we can do so. And then we can begin our risk analysis and mitigation processes.
One of the other benefits that I believe of using E-Topics and the Accel-Tracker tracker
tool, is that you can use E-topics to auto-generate a PDF file that clearly summarizes the entire
prioritization and evaluation process surrounding the signal of interest. In this screen shot
example I am just showing you a simplistic PDF that is generated from the system to clearly
outline what questions were asked and answered of our signal management tool. And in addition
to that, we can see entire histories of the signal management procedure, again within
that existing PDF if you choose. So this becomes a very helpful tool when responding
to any internal or external audits, where questions may arise as to why we did or did
not see potential signals in our data, earlier on, rather than later.
So, in summary, I do believe that we have used the existing literature and the Empirica
Suite to configure a tool that has a great deal of value out of the box, to allow you
to identify your potential issues, although it should be noted we did not configure the
E-Signal tool at all. All of the slides I showed are basic functionality of the E-Signal
tool. And again, not to give the E-signal tool too much of a plug, but it is, in fact
the exact same tool that is used by the FDA for their signal detection mechanism. But
we also created a series of workflow steps for the signal prioritization, evaluation
and risk process. And have pre-populated the number of literature specific questions that
we feel are, or should be your organization, in order to fully address the formal evaluation
of your signals.
While I did not, one of the things I would just also like to point out, While I did not
point out the use of the E-topics or the Accel-Tracker tracker tool in the clinical space, it should
be very noted that E-topics solution and ultimately the Accel-Tracker tracker tool, can be used
without integration to the E-signal tool. So, for example, if you are a small to medium
organization who are largely focused only right now, on clinical phase studies, phase
one, two, three studies, you too, could utilize the Accel-Tracker tracker and E-Topics tool
as demonstrated in this slide deck. The only difference would be the signal detection process,
that would begin in more traditional approaches, as I discussed at the beginning of this webinar.
So you would simply be looking at, for example, striking cases. Let's say you have a relatively
small clinical trial ongoing and three patients experience Stevens-Johnson Syndrome. You can
use that as the identified signal. Enter that into Accel-Tracker tracker and track your
work up of that signal within your clinical trial data. To fully document and prove to
an auditor what exactly you did when certain issues within your trial data were found.
So there is merit in the E-Topics tool both when integrated to the post- marketed surveillance
tools like E-Signal, but I firmly believe that there is merit in implementing a tool
like E-Topics, even in the clinical space. Again for the exact same purpose, to document
clearly our prioritization and evaluation of important signals to our organization.
So, what can we do after this webinar? Well, I believe that there are probably stages to
people's readiness to accept such a decision support system and its use or usefulness in
their organization. So if you're not quite ready for something like this, then we are
fully willing to collaborate on requirements or discuss why or why not your organization
would even benefit from a piece of software of this nature.
Some of you might be already in the midst of using or implementing the E-Topics tool.
We certainly would suggest that a refinement of the default E-Topics implementation might
be of interest to your organization, specifically with configuring or in your case, re-configuring
E-Topics tool to the Accel-Tracker tracker model.
Others of you may be just more interested in a live, in-depth system demo of the Accel-Tracker
tool and the capabilities that it has. Still others may prefer an on-site proof of concept,
this is typically in the e-Signal area. What Oracle does on a routine basis and certainly
for e-Topics, we could definitely partner with them to accommodate a proof of concept
for your organization.
And then, finally there could be some of you out there that do your signal management,
but right now, you use another tool or do it manually. But you might want to, or could
benefit from an evaluation of your relevant processes and how well they compare to the
existing literature and the CIOMS VIII Working Group. Again, our company, we believe has
a great deal of information to share with that respect.
Before we wrap up, I just want to pull out our references and to note that I have given
you all the references used in this slot and so there again, are some really good articles
and textbook present here.
And lastly, if there are any other questions or concerns or comments, please feel free
to email me or to call me. I think now I can open the floor up for questions, if that is
okay.
Great, thank you Rodney. Before we move onto the question and answer session, I would just
to remind everyone that they can ask questions via the chat feature on the left-hand side
of your screen. We'll try to answer as many questions as we possibly can as time allows.
So we'll move onto the first question. And I apologize if the questions may not be as
clear. I am just going to state them as they were typed in.
Question #1: How can duplicate signals be detected by the computer database or the robotic
process?
Answer: So again, I would just like to state that I really don't want to focus on the signal
detection arm of this tool. That is the e-Signal tool itself. I would want instead to defer
that question and how about we get them an answer directly from Oracle on the ability
to notice or not notice duplicate signals from the signal detection piece, Now from
the tracker piece, form Accel-Tracker, I will stipulate in the log-on screen to the tracker
tool, you will have the ability to filter all of your signals by a series of pre-determined
categorizations. So you will be able to see if you or someone in your organization has
elevated the same signal or perhaps even a similar signal. And one thing I didn't go
over, is the ability to join case series to one another in order to further collaborate
on potential signals that may be relevant. In the example that I gave specific to tooth
decay, if we spent some time in looking at the other socks in this sector mapping of
this signal detection, you would see that there were in fact some internal validations
in the other system organ class categories. For example, a large number of gingival disease
categories in the musculo-skelatal sock, also could indicated some support of osteo-necrosis
occurring in the patient population. And certainly we would want to eventually be able to join
those two signals together, to further support an ongoing signal of Oesteo-necrosis.
Alright. Question #2: Can expectedness be pre-populated by the system according to a
core elistedness data sheet?
Answer: So currently, at least in my experience of configuring the system. No, not right now.
In fact a lot of the automation that we would probably prefer the system to accomplish,
in its current release state, the Topics tool does not accommodate.
Question: Thank you. Is the prioritization of signals purely subjective or is it perhaps
a mathematical formula or algorithm to produce a score to assist in the prioritization?
Answer: Again there are a number of prioritizations scoring mechanisms available in the literature.
The MHRA has not made their prioritization scoring methods public yet, but there is an
ongoing journal article, that once published should explain exactly what math they are
using. One of the articles in the reference slide does, in fact, identify a decision support
algorithm used by Johnson & Johnson in their signal management and that is very clear and
robust. So OI would point you to that article.
Question: Great. Thank You. Can the AERS system do management and if yes, what is the advantage
of Empirica over Argus Safety?
Answer: So now, this is an opinion of my personal opinion working with both systems. So Please
temper that with what I am about to say.
So, as all of you are aware, your safety systems are primarily for your individual case safety
reporting needs and your documentation of the work up of those individual cases in the
system. While you could so such things as elevate user defined fields in the Argus Safety
system to document whether a case is a signal or part of a signal, this is not something
that the system is meant for out of the box. Furthermore, it could become very tedious
making sure that all of the required pieces of information that you need to fully document
your signal management procedures are accommodated directly within the Argus System. You can
use Argus Safety to identify your signals, wither with post-marketed individual case
safety reporting or in your clinical trial data. So I would argue that the initial phase
of the signal management could be accommodated by Argus Safety, but the prioritization and
evaluation might become a little too cumbersome.
Question: Great Thank you. Is the Accel-Tracker tool completely integrated into an Emprica
signal user interface that is, once you are logged into a signal or e-Topics, you have
access to the Accel - Tracker, workflow steps and capabilities?
Answer: So, yes. The answer to that is yes. The Accel-Tracker tool is actually Empirica
Topics, it's just fully configured.
Question: Can Accel-Tracker be configure to meet the new EMA guidelines on signal management
process?
Answer: And again yes, the tracker tool could be augmented to conform to any signal prioritization
or evaluation mechanism that you use within your organization. This initial release by
BioPharm is just our suggested mechanism for compliance with CIOMS VIII. Of course, I understand
compliance with the CIOMS Working Group report is not required, but we needed to start somewhere.
Question: Could you please give more details on the list of values associated to each prioritization
criteria such as strength, novelty and importance of the signal? Are they numerical scores?
Answer: In this example, no. They are not numerical scores, they are categorical. In
the decision support article where these categories were suggested, they ended up being numerical
scores that were in fact weighted against Johnson & Johnson's data to calculate an overall
prioritization score for the signal.
Question :Can the software perform any of the mathematical scoring or is the work flow
a manual process outside the system?
Answer: So, it cannot, currently in its current release state, do any of the mathematical
scoring. However, it will allow you to flow this signal along the work flow right within
the application. So the modification of moving a signal from prioritization to evaluation
to risk to monitor back to the prioritization. However, you flow the work flow, that is all
accommodated within the system but it is manual.
Question: Great. The next question is Can you please share the name of the author of
the signal prioritization article that you mentioned by J&J?
Answer: Uh, yes it is Bennet E, Russo-Baney Thomas, Klienvitz, yeah Kleinvitz. Again,
it's all on the reference slide of the presentation.
Great. Thank you. Well, at the moment, we don't have any more questions. I'll give it
another 15 seconds to see if we have any additional ones. Just, please type them in the chat feature.
Question: There is a question about maintaining the system. What about the maintenance.
Answer: I'm not sure, okay great, uh good, that clarifies it. I see that the specific
question of maintenance was regarding where in fact this system is maintained. And this
is a great question. So BioPharm is a gold partner with Oracle specifically we have been
working with them for a good deal of time now on the e-Topics tool specifically. And
right now, and in our current model, the -Topics tool would be hosted by Oracle as the question
implies. But it would have in it the prioritization, evaluation and work flow segments specific
to the Accel-Tracker tool. So again, this is where one of the benefits of working with
BioPharm and Oracle are very pronounced.
Ending: Great. Thank You Rodney. Looks like we are getting close to the hour and we used
up the allotted time we have for this webinar. So that will end our Q & A session. If you
do have additional questions, please feel free to contact us directly or Rodney. His
information is on the slide. And once again, please note that today's webinar will be available
on at BioPharm.com within 24 hours for you to review and share with your colleagues.
We do thank you for your participation and hope that the information Rodney provided
was very helpful. Have a great rest of the day and we look forward to having you on future
webinars. Thanks so much.