Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS) Integration

Clinical Trial Management System (CTMS) and Electronic Document Management System (EDMS) Integration


Hello everyone. I would like to welcome everyone
to BioPharm’s 7th webinar in our series of CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) webinars.
In today’s webinar, we’ll be focusing on integration between a clinical trial management system
and an electronic document management system. In case you’ve missed any of our previous
webinars, or you would like to watch them again, the recorded presentations are available
for download on our website, www.biopharm.com . We’ve covered a variety of topics past webinars
and have some interesting topics coming up as well. And if you have any ideas for topics
that you would like to see in these webinars, please send us an email.
Let me start out by introducing myself, my name is Param Singh. I am the Vice President
of the clinical trial management solution practice at BioPharm Systems. I have been
working in the health and life science industry since 1999, and have almost exclusively been
working with Seibel Clinical during that time. Before joining BioPharm nearly 4 years ago,
I was part of Accenture’s Pharma R&D Practice and leading Seibel CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS) implementations there as well. In overall, I’ve been part of now 15 implementations
of Seibel Clinical. And these vary from implementations for pharmaceutical companies, contract research
organizations, medical device companies academic institutions, and they also range anywhere
from 30 users to global implementations of over 4,500 users.
And with each type and size of organization, they have their own approach to to selecting
and implementing the solution and also integrating it with a variety of document management systems
as well, and we’ll be discussing those today. Here’s today’s agenda. We’re going to start
with an overview of the benefits of doing this sort of integration. Then we’ll look
at three different approaches to electronic document management system and integration.
I know that the webinar description listed 2 approaches, but we’re actually going to
present 3, and we’ve actually prepared 3 for you today on today’s webinar. And we’ll wrap
up with a live demonstration of all 3 approaches and then we’ll have some time for questions
and answers. Before we get started, I do want to point
out a few features of the platform we’re using, Ready Talk, right now we have everyone on
mute and if you have an issue. Please click on the raise hand button, and we’ll pause
and address the issue. Also, for the question and answer portion,
feel free to submit your questions at any time using the chat window or the chat feature
on your screen. Those questions are going to come directly to me and I’ll answer them
during our Q&A session. So, that’s the best thing to use for submitting questions for
today. And, I also want to remind everybody that we are recording the presentation and
it will be posted on our website afterwards. So, let’s get started. So let’s first start
by looking at potential benefits of integrating your document management system with your
CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). First, it really streamlines your document tracking
process. As you’ll see with certain approaches to this integration, you’ll significantly
reduce the number of steps in this process and actually automate part of the process
as well. Which speaks to the second point of reducing
data entry and errors related to that duplicate data entry. It’s going to reduce time as well.
In some cases, as you’ll see today. And also, once that link is made between the two systems,
you no longer have to jump out of one system to another and search for related documents.
The link is there and this integration eliminates now the need to search for those relevant
document files in your document management system.
Also in the same regard, it’s going to simplify audits as well. Where auditors are looking
for data in your CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and your files in your document
tracking system. So, now again, we have that link they don’t have to do that searching
and actually correlating data in one system to files in another system.
Let’s look at a particular example of some solid benefits. Let’s look at the process
of the Trip Report in the system. With a robust CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) which
is integrated with an electronic document management system, we can first complete the
Trip Report electronically, in the system utilizing our data in our CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS). So, we’re taking our checklist, we’re taking our follow-up items, our CRFs,
and pulling all of that together electronically with data in our CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS). The user can then submit it, via a full 21
CFR part 11 electronic signature capability in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS).
The manager can then approve the Trip Report electronically, in the CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS) utilizing that same e-signature capability. We’ve actually demonstrated that
capability, that e-signature capability in previous webinars.
So, it’s customizing and configuring that review and approval process in your CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS)/ So, then once the Trip Report is now approved in the CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS) system, the system, which is now fully integrated with
electronic document management system, can then send that signed PDF, the electronically
signed PDF report, to your document management system and store it in the electronic trial
master file in that site and study sub-folder. So the systems and the integration are now
doing most of the work for you. Enabling, enforcing and supporting that entire process
of completing, reviewing, approving and archiving that Trip Report.
So we’re going to discuss three approached today, like I mentioned. And the first approach
to this integration is what we like to call the Mock approach. What this approach does
is when you create a document tracking record in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS),
that action will automatically create a URL hyperlink in a field on that record, which
points to the expected location of that document in your document management system.
And the way that it does that, it mimics the folder structure in CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS) and assumes the same hierarchy in the electronic document management system.
And the reason we call it a Mock approach is that this is not a true integration. There’s
no real communication between the two systems. We’re just populating a reference link and
one system to the actual file in the other system. So there’s no communication, we’re
just actually linking the two systems to that reference point.
So how does that work? Well the first step is that we create a document tracking record
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). And there’s a calculated field in the CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS) document tracking record which takes a standard URL path and
adds the specific protocol and site identifiers to it. You can also add program and region
if desired, but the protocol and site is what is required and unique about where you are
storing those documents within CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and your document
management system. So, here’s an example in step 3: the first part of the URL is a standard
hard-coated path and the items in red are calculated based on where that document record
is being created within Seibel. So, it’ll take the protocol number and the
site number and it will append it to that fold to create a certain path to create a
full path to the folder where that document for this site should reside in your document
management system. A note down here says that it requires the same folder structure in both
systems. So, to be able to generate a path that is going to be unique for each protocol
and site the folder structure in both systems needs to be similar in nature.
So, what are the pros and cons to that approach? Well, the pros are: this is a very inexpensive
and quick functionality to implement. Since it’s not a real integration, we’re basically
just adding code behind one field to logically build a URL pointing us to the appropriate
folder in the other system. So, it’s not a true integration, it’s relatively inexpensive,
there’s not a whole lot of, you know, testing of scenarios since we’re not passing data
back and forth. It’s not extensive, so it’s relatively inexpensive to move forward with
the Mock approach. The cons to this approach is that it is less
precise. The URL that we’re building doesn’t necessarily point to the document itself,
it points us to a site folder on that document management system. So, once we’re in that
folder, we still have to locate and find our document.
Another con is that it populates that URL as soon as that document record is created
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). So, every document underneath a site will
actually have the same URL pointing to the same site folder. So, there’s nothing indicating,
nothing in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) that gives us an indication that whether
that document truly exists and has been upload to your document management system. So, once
we click on that link and go to that folder and search for our document that’s the only
time we’ll know whether that document actually exists there or not and has been uploaded
there or not. The next approach is what we call the Electronic
Document Management System Driven Approach. So, the ELECTRONIC DOCUMENT MANAGEMENT SYSTEM
(EDMS)-driven approach is when it starts in your document management system. So, what
does this do? We auto-generate a hyperlink in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)
when that document is physically uploaded to your document management system. So, as
soon as that document is uploaded, we upload some information with that document and it
automatically then will generate a hyperlink to the relevant records in CLINICAL TRIAL
MANAGEMENT SYSTEM (CTMS). And, so once that hyperlink is auto-created
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS), we can actually then share metadata about
that document back to your document management system. And, we’ll get into some of the details
on that as well. So how does this work? So, one, our document
tracking record is created in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and that includes
a document “code” or a document identifier that’s unique to that site. So that’s a pretty
important step. And, so what this assumes is that document tracking record is already
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) before the document is uploaded.
So, the second step is that the document is uploaded into your document management system
and the required metadata is entered, including that document code. So, that’s what enables
that link between that document tracking that you created in step one and that document
you uploaded in step two. So, once that’s done, the interface then finds
that corresponding record in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and through a web
service, passing that information on and populates the URL with a link to the document in your
document management system. So, let’s look at the pros and cons of this
approach. So the pros are: now we’re linking directly to that document. It’s not a URL
directly to a site folder on your document management system, it’s actually a link to
the document, so you don’t have to search. It is actually easy to see which documents
have and have not been uploaded to your document management system. Because the only ones,
the only document tracking records in your CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) that
will have a URL link will be the one that have been uploaded to ELECTRONIC DOCUMENT
MANAGEMENT SYSTEM (EDMS). It’s very easy to see which ones have already been uploaded.
And then you can share document metadata in both directions. So, as you’ll see in our
example, when we upload the document, we’re actually only required to put in a very minimal
amount of information and metadata for that document, such as protocol number and site
number in that document code. So, at most, three pieces of metadata with that document
when we are uploading it. But now that the link has been established between the two
systems, CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) can actually share a whole lot more
metadata about that document back to your document management
system, such as PI last name, first name, the account name, and various other dates
and statuses related to that document record in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS).
So, what are the cons to this approach? Well it requires that document record to exist
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) ahead of time. So, there still is some manual
setup that we have to do in one system to ensure that the link is, that we’re establishing
that link between the two systems. And the last approach is your CLINICAL TRIAL
MANAGEMENT SYSTEM (CTMS)-driven approach. And, so what does this do? Well, through STMS,
we’re actually creating, automatically creating a document record, the document tracking record
in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and uploading that physical document to your
electronic document management system automatically at the same time.
So, since we’re doing everything in both systems with on action, it auto-populates a link in
CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) to the record in your document management system.
So, we don’t actually have to do any manual sort of setup in this scenario since we’re
actually uploading the document and creating the document tracking record at the same time.
We can actually establish that link in that same action. And since that link is there,
you know, we can share that metadata about the document similar to last approach as well.
So what are the steps to this? So, we’re going to be starting in CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS). Most of this happens in your CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). So,
we’re uploading the document as an attachment into CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)
and we’re entering required metadata while we are doing that upload. In today’s example,
you’ll see a button called sendfile. This is specific to what we have done in our Seibel
system, but you are going to send, you’re going to click the sendfile button, which
will actually do a series of actions. It is going to create the record or upload that
document to your electronic document management system, that file you just attached and it
is also going to create a corresponding document tracking record in CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS) and that link is going to be established there as well that is going to
point directly to that document that we uploaded. And, a third note is that we’re then going
to maintain that document in your electronic document management system. So, the file itself
was, we use CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) to upload the attachment and then send
it to your document management system. But, now that it is there, any sort of version
control, any sort of, you know, updating the content of that document is all going to happen
within your document management system. So, the pros to that approach: we’re creating
all documents and document tracking records simultaneously. So, there’s one action and
the hyperlink will always point to the same location in your document management system.
So, it always links to the most current version of that document. So, there’s ways for us
to enable this integration , so even when you have an up version of documents that the
link will remain current. So, if I uploaded version two, when I click on that link in
CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) it should take me to version two of that document
rather than version one. The cons to this approach: The original version
of that document is always available in your CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). We
utilize that for our initial upload of that document through CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS) that original version is going to be available in CLINICAL TRIAL MANAGEMENT
SYSTEM (CTMS), which could be compliance risk. There is some additional configuration that
you can do to address that issue, mainly, as you transfer that document maybe deleting
that version of the document in your CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS), so you’re
always looking at files that are in your document management systems. So, there’s additional
configurations that you could do to address that potential issue. But, we haven’t done
it in today’s demonstration necessarily. Okay, so we’ll go into our live demo. I’m
going to share my desk top here. And here we are in our Seibel system and we’re also
logged into Al Fresco, which is our document management system that we use at BioPharm.
So, we’ve created a prototype between these two systems. So, we’ll look at both, we’ll
look at all three actually approaches live in our systems today.
So, the first approach is our Mock Approach and this I’m going to demonstrate, I’ve actually
created a few sites here for our ELECTRONIC DOCUMENT MANAGEMENT SYSTEM (EDMS) demo. And
we’ll walk through each of these site for each of the three scenarios.
So the first scenario, we’re going to go into site two, and look in our document tracking
view, and you’ll notice that all of the documents here that are listed all have a URL and it’s
the same URL. It’s basically pointing us to a specific folder in our document management
system where each of these files will reside. So, if I click on this, it’s actually going
to open a folder. You’ll notice that there is five documents that are tracked in my Seibel
systems, in my CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) systems, but when I click on that hyperlink,
it only shows the PDFs that are uploaded. So two Trip Reports and a 21 CRF part 11document.
So, it doesn’t necessarily, there’s no indication here to tell us which one of these documents
or which of these documents are actually available to us on our site folder on our document management
system. It just literally points us to the folder that itself.
And through configuration, any time you create a new record in the system, it is actually
going to, you know, automatically populate it with that same URL. Because we’re underneath
this particular protocol and this particular site, so it’s actually calculating that path
utilizing the protocol number and the site number for this particular site to populate
that URL path. So, that’s the Mock Approach. It’s very simple and straight forward, we
basically just put some logic behind this URL field and take in values from the protocol
numbers and the site number and build out this path. Through that fashion. So that’s
our Mock approach. Our second approach, which is our ELECTRONIC
DOCUMENT MANAGEMENT SYSTEM (EDMS)-driven approach so that everything that happens starts from
our, starts from our, our, electronic document management system. So, for that I’m going
to go into our document management system, and I’m going to go into site 002. And you’ll
notice there’s three files here, I’m going to I’m going to insert another file. So I’m
going to upload a file and I’m going to pick another Trip Report and I’m going to click
upload and here is where we add some metadata to this particular file. So, we would, let
me delete one of these. Oh, I’m in site two, so I’m actually going to jump into site three
and here is where I’m going to upload my Trip Report.
So, I’m going to add content and look for my Trip Report, upload it hit okay. Here is
where you would add some metadata to this particular upload so we would add protocol
number, we would add site number, and we would add a document code. So, I’m going to put
in this doc code of 1234 in the description field. So I’ve put in that doc code and now
my file should be uploaded onto site 003. And through a web service, now, if I go back
into my Seibel system, and go into our site 003 under my document tracking record, you’ll
notice that there’s a series of documents here, but only five of them have a URL link
to my document management system. So that tells me that although I have 8 documents
that I’m tracking, only five of them actually exist, the physical versions of that electronic
are, there is only five of them that exist in my document management systems.
And here’s all of our Trip Report that we just uploaded. So, there’s my document code,
that showed up here under description and here is the path to the document. And the
great thing about this approach is that we’re not pointing to a folder, we’re actually pointing
to the document. So, if I click on this link, It will actually open if I have access to
that particular document according to the security profile in my document management
system, it will open up that Trip Report document, that PDF. So here I’m looking at the actual
document pulled out of my document management system. So, that goes for anyone of these
documents. So, if I click on anyone link, it’s going to pull up that actual document.
So I clicked on 1572 and it’s going to pull up 1572 document that was on my Al Fresco
system. So that is our Document Management driven approach to this integration.
And the last approach that we have is our CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) driven
approach. So with that we start in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and go into
site 001 file, and for this one, I’m going to start in attachments. You’ll notice there
is no attachments here listed and if I go into document tracking there’s no document
tracking records as well. So, going back to attachments. Now, before, actually let’s create
a new file, and I’m going to select the 1572 document. It gives you some specific metadata
about that document that it’s PDF, how big it is, you know when we uploaded it. We also
get to put some document type and description. So, I’m going to say that this is my auto-upload
of 1572 for site 001. And before I hit the sendfile button, I’m actually going to go
into my Al Fresco client and go into site 001. And you’ll notice that there’s no documents
here. So, we haven’t sent that file yet. We haven’t uploaded it yet.
So, I just wanted to confirm that there is nothing there. So now I’m going to hit the
send file button and it’s going to do three things: the first thing it is going to do
is create, it’s going to upload that document to Al Fresco. So, if I, just going to wait,
okay, there we go. So, I’m going to go into Al Fresco and refresh this folder and you’ll
notice there is our 1572 PDF that just got uploaded right now. And, if I go back into
my Seibel systems, now I’, going to look at my document tracking, so the second thing
it does is that it creates a document tracking record automatically. With the activity type
and the description that I entered as metadata when I was uploading that attachment.
And the third thing it does is it creates this link which points directly to the PDF
document. In our Al Fresco system, in our document management system. So it has done
all three of those, three of those actions as soon as I clicked on sendfile in the attachments
view. And to confirm that this record is tied directly to that document, what we’ve done
is on this record itself, we’ve taken the row ID and I’m going to look at the row ID
by just to help about records . And we’ll see that the row ID is 1-1KRQY, os that is
the row ID of this record right, this document record right here. And it I go back into my
Al Fresco, what we’ve done is when we’re creating and uploading that file, we’ve actually made
the row ID of the tracking record, we’ve appended it to the name of the document that we’ve
uploaded. So, just to help us visually confirm that, in fact, both of those records are tied
together, we’ve added the row ID as part of the name of that particular document. And,
again, if I click on the link Seibel CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) or in here,
it’s going to pull up that document that I just uploaded from my desk top.
So, with that end ours demo. I’m going to go back to our slide deck here and what we’ll
do now is we’ll open it up for questions that you may have. So, if you do have a question,
like I said, the best method is to use the chat feature to submit your questions and
will address the questions as we receive them. So, I’m just going to go through the questions
that I’m getting. First question is: can the slides for the
talk be provided to the participants? Unfortunately, we don’t provide the slides of our webinar
presentations to our participants, but like I said before, our webinar will be recorded
and the recorded version of the webinar will be available online on our website, www.Biopharm.com
Next question: What happens to the links if the file name or the contents of the file
need modification? Well, with each approach, this is handled in a different way, but in
each scenario, this potential issue is addressed. So in the Mock scenario, since we’re pointing
to a folder location, any modification of the file name or contents of any of the files
is not going to impact the link from CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) to your document
management system. In the ELECTRONIC DOCUMENT MANAGEMENT SYSTEM
(EDMS)-driven approach, where we upload the document first in our document management
system, what we’ve done in this scenario in actual integrations is that with each upload
of the document in your document management system, whether it is a new document or a
new version of an existing document, we have our web service run at each time. So if the
URL in the new version has changed, it would automatically update that URL in CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS) as well. So the result would be that the URL is pointing
to the latest and most current version of that document.
Um, the next question we have is: What web services are you using for this integration?
Well, we’ve built custom web services for both the CLINICAL TRIAL MANAGEMENT SYSTEM
(CTMS) and ELECTRONIC DOCUMENT MANAGEMENT SYSTEM (EDMS) integration approaches. We’ve
built custom XML integration objects for the data streams that are being exported and imported
and transfer those XML messages using HTTP transport. It’s a pretty standard approach
to web services for this type of integration and, you know with each, you know, different
potential different system that we are integrating to you without the build out from similar,
you know, custom web services from for enabling that integration.
The next question is: Is the actual file not saved into the data base and just the metadata?
Actually, no, in each case the actual document itself is being stored and attached to your
document management system, it’s not just the metadata. And, that’s true for any of
the approaches. So, we’re assuming that, you know, the document itself resides in the document
management system and that’s what we’re pointing to. In the CLINICAL TRIAL MANAGEMENT SYSTEM
(CTMS) driven approach that we did where the initial version of the document is also stored
in the Seibel file system itself before it’s then copied or transferred and eventually
stored in your document management system. So, in any of those cases, we’re actually
talking about the actual document itself being stored in each of those cases.
Next question is: Does this mean that the user must have a single sign on type of pas
through authentication between CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS), Seibel and the document
management system? Well, we’ve deployed this specific integration with or without single
sign on. So, if your systems don’t integrate with your active directory, your LDAT services
for authentication and you just have data base authentication, you would not be able
to do single sign on. Without single sign on, when the user clicks the URL in the CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS) system for the document management system and paths,
it will route the user to a newly opened window, but then it will prompt the user to log into
their document management system using their user name and password before it actually
routes them to the actual document or folder from that URL. But, if single sign on is in
place, then both applications will use your active directory or your LDAP user name and
password for authentication. So, once the user clicks on the URL from CLINICAL TRIAL
MANAGEMENT SYSTEM (CTMS) the system, since you’re already logged into Seibel with your
active directory passwords, The system would pass the user credentials to that new window
and automatically log them into their document management system. So that, of course, is
more streamlined, you know, it’s a more streamlined process and it doesn’t require multiple log
ins for that user, so it’s less frustrating from a user point of view. In either case,
however, the security and access profile are intact for the document management systems.
So, if a user clicks from a document record in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS),
which, you know, they shouldn’t have access to in the document management system, once
the new window opens and their authenticated in either method, the document management
system should then throw an error to the user letting the user know that they don’t have
access to that document or folder. So all of your security in each of these cases is
unique to the system and it doesn’t sort of override in any security profiles that you
have in either system. The next question is: How would you track
from trial master file documents that are born as paper? So any and all documents that
are born as paper and routed for wet signature, for example, through your organization will
still, at some point, eventually be scanned and uploaded as PDF to your document management
systems as part of your, you know, electronic master file.
So each of the approaches that we discussed today can still apply. Once that physical
document is scanned, you know, converted to electronic PDF document you can employee any
of the approaches that we have laid out for the integration. So, everything still applies,
even if the document is born as paper. Next question is: Which of the three approaches
is more conducive to creating internal/external work flows for document review, approval and
e-signature? Well, working with some document management systems in the past, we have come
across some very robust functionality for review and approval work flows, electronic
signature capability, et cetera. If your document management system employees some of these
modules and functionality, then it would be appropriate to utilize those in your document
management system. Any and all of these three approaches that through integration would
work with that overall setup because that review, approval and signoff work flow would
be activated once that document is again physically uploaded to your document management system.
Although, if your document management system does not have review, approval and electronic
signature capability, you can certainly build that in Seibel CLINICAL TRIAL MANAGEMENT SYSTEM
(CTMS) on your document tracking module. So, we’ve implemented this type of e-signature
capability for Trip Reports, and we have actually demonstrated that in a past webinar related
to Trip Reports. So, you can certainly replicate that functionality to allow for review, approval
and signature capability for all of your documents in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)
as well, if in fact, you’re doesn’t management system doesn’t allow for that.
Next question is: Do you integrate any workflow review, approval functionality into the integrated
approach and how do you handle e-signatures? So, I think this is again, similar to the
previous question. And, it will again depend on the extent of review, approval, e-signature
capability of your document management system. So, if it is there, we would recommend using
that inherent functionality in your document management system and integrating to the document
tracking module in CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS), like we’ve shown in our demonstration.
Next question is: Would any of this architecture, CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) or
EMDS driven work when both systems are SASS based? The answer to that is yes. It should
work for sure if the system has the capability to communicate over Http. So you would have
to again build custom web services for those services, but if they have capability for
web services over HTTP, the same approaches should work.
Next question is: Can your custom web services be used with sharepoint rather than a CLINICAL
TRIAL MANAGEMENT SYSTEM (CTMS) system? We can’t necessarily use the web services that
we have built here to use for, I guess sharepoint and other systems necessarily as is. We would
have to create new custom web services to ensure that they system that aim to integrate
are sending and receiving the appropriate data objects. We can try and
leverage the approach and what we’ve done in terms of design and development of the
web services, but it’s most likely we would have to, it would have to be a new custom
web service for those systems. Another question: Have you worked on any of
these integrations with other ELECTRONIC DOCUMENT MANAGEMENT SYSTEM (EDMS) tools other than
Al Fresco? Yes. As I mentioned before, we have worked on these types of integrations
with a variety of document management systems solutions such as sharepoint, documentum,
livelink, IBM’s file net P8 system and Al fresco. And we’ve actually integrated or done
similar integrations to, even, through CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and even just
a network share which an organization was using as their sort of document repository.
Again, it didn’t have any sort of robust features of check-in and check-out and version control,
but they were utilizing a network share for their CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)
so we had actually integrated with that as well.
But, any web based ELECTRONIC DOCUMENT MANAGEMENT SYSTEM (EDMS) solutions would be able to work
with any of these approaches to the integration that we discussed today.
Next question is: Will and can this integrate with clinical data management systems. The
answer to that is also yes. We’ve actually done several integrations with clinical data
management and electronic data capture systems as well. And in fact, one of our past webinars
discussed that topic and we provided a detailed presentation on our integration between Seibel
Clinical and Oracle Clinical and RDC. So, again, please check our website for that
past webinar if you are interested in that integration.
Next question is: Related to validation. How involved is the validation efforts since both
CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) and ELECTRONIC DOCUMENT MANAGEMENT SYSTEM (EDMS)
will be touched? And unfortunately, this is a “it depends answer”. It really depends.
While any integration whether or not you’re validating the system and the integration,
the testing of that integration is going to take a significant effort. Again, you’re dealing
with multiple systems and testing our multiple scenarios, so, the validation requirements
or the testing requirements are significant. Validation requirements for your system is
really going to be driven by your internal validation group and how they define, you
know, the approach to validation. So, if, you know. Historically, you’re a risk tolerant
organization, then that maybe less of an impact and if your organization is historically risk
diverse then the impact may be a bit more substantial.
But, again, in either case of validation or no validation just simple testing the integration
is really still going to be a significant effort. Because, you know we are dealing with
two systems and the transfer of data, so we have to test out multiple scenarios and also
test out all the air handling, so you don’t want to lose anything in that transfer as
well. So, in planning for that, you know, be prepared to have ample time for testing
in either case. And I think we have one final question, which
is: What is the cost for each? I knew we would get a question related to cost, so, unfortunately,
here’s another “it depends” answer. But with each of the three approaches that we’ve discussed
today, it’s easy to say that the first approach, which is the Mock Approach, which isn’t a
true integration, you know, in its classic sense would probably be the most
straightforward and least costly option with this, you know, tying the two systems together.
And it is one that, you know, a lot of organizations sort of go down the path of initially. The
other two would, the other two approaches would depend a lot on the other system that
we’re integrating with and the specific requirements your organization has on the metadata that
it is going to share between the two systems and other specific configurations, on, how
we’re, you know, how we’re organizing that integration.
But, as with any real integration, you know, on any system integrations tend to be high
ticket items. And when validation is concerned, the effort and cost of course, can increase.
So, as mentioned before, the most amount of effort that you’re going to spend at integration
implementation will certainly be in the testing of it and planning for the testing of it.
Ensuring that all of the scenarios are properly tested.
So, this is a significant investment to do some integrations like this, but we can certainly
speak with your organization about your specific requirements and understand our and leverage
what we have done in the past. And generate a high level estimate based on your specific
situation. But, again, the Mock approach is relatively
less costly, and if that meets your needs, you know, maybe that’s the best solution in
the short term you know from a cost perspective. So, I think that’s all the questions that
we had. If there are additional questions, feel free to send us an email and we’d be
happy to answer any specific questions that you had.
So, with that, I do want to thank everyone for joining us today and sharing the past
hour or so with me. I hope you found it was time well spent. We also have additional webinars
planned for August and September. In August, we’ll be covering the top ten reasons why
you need a CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS). So that webinar is going to help organizations
who are working on building a CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) business case, put
together a compelling argument of the need for a CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS).
In September, we’ll be looking at Seibel Clinical from a job function perspective. So, for example,
if you’re a clinical finance person, how could Seibel Clinical help you do your job? So we’re
going to look at it from a role perspective in that webinar.
In October, we’re going to take a break from the webinars due to the Oracle Health Sciences
User Group annual conference, which is happening in Toronto this year. And we’re going to presenting
a few sessions there as well. WE hope to see you all there. If you want more information
about that, please visit the user group website, which is OHSUG.org. and you’ll find the sessions
and the conference as well. Again, as a reminder, today’s presentation
will be available for download from our website shortly. If you do have any additional questions
or you would like to discuss your organizations needs to determine the best option for integration
or an implementation of a CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) feel free to contact me directly.
My email is on the screen and with that I will thank you again and hope you enjoy the
rest of your day. Thank you everyone.

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