The ABCs of Clinical Trial Management Systems

Hello everyone. Thank you for your patience and welcome to
the Webinar entitled: “The ABCs of Clinical Trial Management Systems”, presented by
Perficient’s Param Sing, director of Clinical Trial Management Solutions. My name is Eugene Sefanov and I am the Marketing
Manager for Perficient’s Life Science Practice. And before I turn it over to Param, I’d
like to go over some housekeeping items with you. During the presentation all participants will
be in listen-only mode. However, you may submit questions to the speaker
at any time today by typing them in the chat feature, which is located on the left side
of your screen. Please make sure you state your questions
clearly and keep in mind other Webinar participants will not see your questions or comments. However, your questions to the speaker will
be addressed as time allows towards the end of the presentation. If you still have unanswered questions after
the Webinar, or if you’d like to request information about our services, feel free
to use the contact information on the various slides throughout the presentation. You can also fill out the contact form on
the Life Sciences section of Perficient’s website. Keep in mind that today’s webinar is being
recorded and it will be sent to you within several days. A link to the PDF version of the presentation
will also be included in that email. This wraps up our housekeeping items and I
would now like to turn the call over to Param Singh. Thank you, Eugene. Hello everyone. I’d like to welcome you to today’s Perficient
Life Sciences CTMS Webinar. Today we’re going to discuss the ABCs of
CTMS. So, we’re going to go through some basic
ideas of what a CTMS is, what types of organizations need them, some key functions and best practices
when implementing and collecting CTMS systems. So, let me start out by introducing myself. My name is Param Singh and I’m the director
of the CTMS practice within Perficient’s Life Sciences Business Unit. I’ve been working in the industry since
1999 and, almost exclusively, been working with the Siebel Clinical during that time. I’ve been with Perficient’s Life Sciences
Business Unit for over six years, since 2008  and that’s including my time at BioPharm
systems as well. And before that I was part of Extension’s
Farmer R&D practice and leading Siebel CTMS implementations there, as well. Now, overall I’ve been a part of over thirty
implementations of CTMS. Let me start by a little bit of introductions
to our company. For those of you who might not know, Perficient
is a large global information technology consulting organization and, actually, we serve clients
mainly throughout North America and Europe; and our strategy and goal is to help provide
business in technology solutions for companies to be able to be more efficient in what they
do on a daily basis. One of our primary goals is to work with clients
not only to deliver solutions, but also to really become a partner with those organizations! We don’t just want to implement something
and then walk away; we want to continue to be there to help provide solutions for you
that help you meet your business needs. So, Perficient was founded in 1997 and you’ll
see that we have many offices throughout the United States We also have some global and
off-shore resources in different countries, as well. We have a pretty sizable workforce, in which
resources are aligned to specific technologies or industries, and have established themselves
as respective thought leaders in their area of expertise. As you can see here, repeat business is one
of our main focuses that we like to talk about, because  again  we want to build those
partnerships with organizations and not just consult the organizations or just implementing
solutions. And this is just a slide here that just shows
some of the areas that we do focus on that we have across our global consulting organizations,
which we bring expertise around the various business solutions and technology solutions
that we bring to our clients. So, a little bit about our Life Science Business
Unit. A lot of you probably know the name BioPharm
systems and have heard it for years in the Life Sciences space. BioPharm was acquired by Perficient on April
1st of this year and now we are the Life Science Business Unit within Perficient’s Industry
Groups. Since the acquisition, our team…our BioPharm
team of experts has remained completely intact, so our services and offerings are still the
same across the Life Sciences arena. We still have fully distinct practices or
focus areas within our Business Unit. I lead the Clinical Trial Management Solution
practice, where we focus on CTMS and our accelerator solution, ASCEND, as well as Mobile CRA. We also have the Clinical Data Management
practice, the Clinical Safety and Pharmacovigilance and the Clinical Data Warehousing practices,
as well. They focus on their own set of products, applications
and offerings. So, within each of our practices we offer
the same level of industry and technology expertise, as we always have, in implementing
and hosting the various applications that we support. And I’d like to wrap up the introductions
just by talking a minute about our CTMS practice and explain a little bit more about what we
do. We provide a variety of services and products
related to CTMS, we manage implementations of Siebel Clinical, whether those are custom
implementations or implementations of our Siebel Clinical Accelerator, ASCEND. We also are starting to implement Mobile CRA,
which is the mobile application that runs on Android and iPhone, for CTMS. Also, if you’ve seen some of our previous
Webinars, you know that we do extensive work on integrations in and out of Siebel Clinical
and related systems. Our approach to system implementations is
very process-focused and we also provide our business process consulting services to help
organizations define and harmonize their SOPs and business processes across their organizations
with respect to clinical trial management. We also offer comprehensive training services
and products related to the applications that we support, as well. So, here’s today’s agenda. We’re going to start out with what the CTMS
system is; what the Clinical Trial Management is; what type of organization needs one. We’ll go over some key functions of the
CTMS and what they should have. Next, we’ll touch on how an organization
goes about selecting a CTMS that needs those specific requirements and budget. We’re also going to discuss the various
system type scenarios and implementation options that are worth considering during that selection
process. We’re going to wrap up the presentation
with a discussion of some best practices that can help you avoid some of the common tip
faults that often impede implementations. And then we’ll have some time for questions. And again, if you do have a question as we
go through the presentation, just feel free to submit it in the chat feature. Those questions will come to me and then we’ll
answer them during the Question and Answer session, as we have time. So, with that let’s get started! So, first…What is a CTMS? A Clinical Trial Management System, or CTMS,
is a technology solution that’s designed to help companies manage all non clinical
aspects of clinical trials efficiently and effectively and, thereby, reduce time and
cost throughout the clinical trial process. A quality CTMS essentially tracks each step
of the clinical trial process, from study startup to study closeout, and serves as a
central depository of Clinical Trial Management information (such as: investigators, sites,
object enrollment, site visits, payments etc). So it’s a single system where information,
such as investigator names and addresses, only needs to be entered once, with a time
introduced error and with all of the clinical trial information in one place. It becomes much easier to extract that information
and use it to make important decisions about a future trial and to answer any questions
about the task. So, who needs a CTMS? A CTMS can be very useful to several kinds
of organizations, such as pharmaceutical companies, contract research organizations (or CROs),
medical device companies, academic institutions. But the common element across all of these
organizations is that they regularly manage multiple trials at the same time. So, organizations that are in that situation
often use several tracking tools to keep themselves organized (whether that’s paper load or
spreadsheet for things like contact names and addresses, patient visits, payments, investigational
products, supplies and even monitoring visits). So, tracking this information in a variety
of different places causes extra work and creates room for error and also makes it difficult
to pull together reports, both from internal review and for outside auditors. Plus these tools are rather difficult to keep
validated. So, for organizations that function like this,
conducting multiple trials at the same time, CTMS can be a great investment that really
pays for itself through the efficiencies it will enable. So, next we’ll discuss some key functions
of the CTMS. a CTMS can support an extremely robust investigator and site database, that
enables complex tracking of individuals and organizations related to your trial. You can track information such as specialties,
experienced patient demographics of the doctors, as well as facilities and equipment that are
available at various clinics and institutions. In addition to investigators and hospitals
or clinics, your contact and account database also allows you to track information about
any person or organization that you may interact with on a clinical trial, such as: lab technicians,
pharmacists, vendor resources and vendor contract offices and shipping and printing vendor organizations,
and even CROs that you use as an organization. So, you can see the value of tracking more
than just your investigators within a central place. You can also track performance of these individuals
and organizations or previous trials and then you can query all of that data to streamline
your site collection process. Or, even aid and choosing a vendor for a specific
purpose on future trials. You know, this feature enables you to detect
the highest performing investigators and place to ensure a smoother trial. And once you’ve selected your investigators
and sites, you can use your CTMS to track essential documents and other site initiation
tasks and to set up subject visit schedules and standard payment amounts and so forth,
for study setup. Once the study is one the way, the CTMS is
used to tack everything from a site management perspective and from site budgets to monitoring
reports. So, for organizations without a centralized
system each of these bullet points on this slide is usually a separate spreadsheet or,
at least, a separate tab in one big spreadsheet; but with CTMS all of this information is consolidated,
it’s tracked in one place  which requires less work to maintain and enables real-time
robust reporting. Also, with CTMS many of these processes can
be, at least partially, automated with integrations to other systems, such as Clinical Data Management
systems or EDC systems for subject and subject visit data information, or a supply system
for product supplies tracking information. One of the most useful apps in the CTMS can
be the enrollment statistics study device. You can learn how quickly specific sites are
enrolling patients, which sites are consistently experiencing screen failures, which sites
are completing subjects on schedule and other related information. And you can cut that data any way you like,
such as by country or by study, so you can get full access to real-time enrollment statistics
for the entire study. CTMS also streamlines the document tracking
process for trials which we know can be a large and costly component of every trial. CTMS can help standardize the document that
must be collected from or set to each site  even country specific documents. And then this information can be queried or
searched to learn, for example, which medical licenses are expiring the next 30 days or
how many documents are due today, but have not yet been collected. So, there’s a series of searches that you
can do in the CTMS to actually track how well you’re doing in that certain document tracking
process in your organization. A CTMS can also provide robust financial tracking
for space, projects and individual primary investigators. When you integrate with an accounts payable
system, the sites payment system can be almost entirely automated, except for those steps
that you want that human intervention  when you’re looking for payment approvals and
verification of activities that have been performed that are registered to be paid for. But essentially, after you track that with
an integration tool or financial system, you can actually automate that whole payment process
between the two systems. And finally, perhaps the most beneficial concept
of a CTMS is its reporting capabilities. Of course, the ability to track all the information
is important, but if we kick all that information out of the system in a very meaningful way,
it’s not very beneficial. So, when all of your trail data is now maintained
in the centralized database, the ability to find answers to all of your trail related
questions becomes much, much easier; you don’t have to look across multiple spreadsheets
or try to collect multiple spreadsheets and tools to try and see how you are doing across
study. And when you have real-time answers to all
these questions, you can make well-informed decisions and it can really have a real impact
on your business. Now that we know more about what a CTMS can
do and what sorts of organizations can benefit from one, let’s talk about how to go about
choosing the right system for your organization. So, the first step in any software selection
process is to gather your requirements. This can be done in a number of ways, such
as analyzing your process and tools: you look at the features and functionality of commercial
systems and talk with colleagues at other organizations. If we just look at our process just within
our own organization, that’s kind of limiting in the scope of the requirements. We really want to understand where the industry
is heading; understand what features and functionalities are available. So, really, looking across all those measures
is going to be a way to get a comprehensive list of requirements. So, once you have that comprehensive prioritized
list that includes feedback from all stakeholders, you’re ready to schedule demos of systems. You may first want to look internally within
your organization for cases like, potentially, other departments or areas within your business
maybe utilizing applications that you can leverage, before looking to external vendors. For example, we did have a situation where
a company was looking to implement a CTMS across their multiple global visit team and
each of those global business units were operating essentially as individual companies since
they were acquired businesses. And when the CTMS initiative was on the way,
they realized that one of the businesses already had a CTMS in place. So, they evaluated that internal application
and determined that it met their global needs and it saved a significant amount in licensing
and implementation costs, by selecting an already established internal system. But, of course, when internal tool or application
exists or is in use, then reaching out to external vendors for demos is the next step. Each system that you do consider should be
evaluated against your prioritized list of requirements, to ensure objective decision
making. After you look at each demo, look at the requirements
the system does not meet and determine how critical these gaps and whether they can be
addressed within your budget, through some sort of configurations, customizations or
workarounds. When you’ve gathered your requirements,
you want to consider the various types of systems that exist and determine which one
makes the most sense for your organization in terms of functionality, implementation
time and budget. A standard CTMS simply refers to a system
that can be used out-of-the-box without any sort of configurations or enhancements. You know, selecting a standard system can
usually save time, but you run the risk of not getting all the functionalities that you
need. Another option is to go with an accelerator
solution, which essentially is a standard system that has been preconfigured so that
there is additional functionality that comes with several commonly requested enhancements
or configurations. You know, accelerators are really designed
to reduce the implementation time for the standard solutions, so, that could be a good
choice for companies that need a robust system with a lot of functionality, but don’t have
the budget (or time) to do of the customizations themselves. And at last, for a customized CTMS either
you start with a center system or you start with an accelerator system, but then you modify
it to your organization’s specific needs. So, you’re really making it specific to
your business and business process. This option is probably, you know, the best
way to meet all of your requirements, but it also tends to be the most expensive and
most time consuming choice! So, if you’re meaning to go this way, the
great way to reduce your time and cost of the customized CTMS is to start with an accelerator
solution that, potentially, already meets many of your requirements. And then you only have to customize or configure
slightly, to meet some additional specific requirements for your organization. Once you’ve looked at your functionality
and requirements and your time and budget constraints, it should become clear sort of
which type of systems would best meet your organization’s needs (across standard, accelerator
or a customized system). So, once you’ve determined that system type,
you want to consider the various implementation options that are available. So, this is when requirements from your IT
organization really become critical. Depending on the size and capacity of your
IT department, you may want to implement your CTMS completely on-site at your organization,
or you might want to share it  at least some of that load  with an implementation
partner. So, with an in-house implementation, your
organization essentially buys all of the software licenses and the necessary hardware and stores
and maintains the hardware on-site. You know, this gives your organization complete
control and responsibility for the system, but it also requires a great deal of knowledge,
time and resources, physical space from your organization. With hosted implementation the housing and
maintenance of the hardware is handled by that external partner, so, it’s reducing
the organization control a little bit, but it also relieves it from the burdens of having
to have knowledgeable on-site resources or the time to maintain servers and the physical
space to have all the equipment. So, hosting has become extremely popular,
especially for smaller in size industries, but even larger organizations are starting
to see the benefits of hosted environment. You know, companies that don’t naturally
have the capitals to invest in a large in-house IT department, or they choose not to, tend
to take this option. These days there are several kinds of hosting
solution to choose from, as well. So, with hosting options, dedicated hosting
is where — And this is sort of nomenclature that maybe you have heard a different terminology
across each of these types. What I’d call dedicated hosting is where
you own the hardware and you own the software already and it’s just simply the external
datacenter housing and maintaining the server  as an extension of your IT department. At any time, you still have the ability to
bring that hardware and software internally for an in-house setup. Share hosting is where you own the software
application, but you’re essentially leasing the hardware which your software is on and,
again, the datacenter is providing and maintaining that. So, if your organization wants to bring that
application in-house, they would have to make a hardware purchase to bring their applications
in-house on their own in-house hardware. And the last option is cloud computing, or
software as a service center (SaaS), which assumes that your organization does not own
any hardware or software and essentially is just leasing this service, to be able to use
the applications on demand. So, as your user base or demand increases,
they just increase their inscription accordingly. You don’t necessarily incur any calls for
hardware maintenance or replacements, but you really don’t own anything in this scenario. It’s simply using the software as true service. Clearly, there are many things to consider
during your selection process; not just functionality. So, here are some best practices to make sure
that you end up with sort of exactly what you need. You want to start out by identifying all of
the stakeholder departments and are representative for each department and you collect feedback
from their respective department. So, once you have all of that, you want to
ensure that everyone’s needs are addressed by the list of requirements. Don’t forget to consider both where you
are today and where you plan to be in two to five years. You’re going to want to implement a system
that can support you as you grow and that has the ability to scale. Next, don’t limit your requirements to simply
system functionality. Consider system types of hosting options along
with data migration and integration. And you also want to include soft requirements,
such as vendor responsibilities and the level of help that’s required by your organization
from your vendors. And finally, once you have your comprehensive
list, you’ll need to prioritize it and get from all of the stakeholders prior the acquisition. You want to divide your requirements into
“must have” and “nice to have” and then rank all of your “nice to have”. You know, find different ways; develop a scale,
such as 0-5 (5 being: meets the requirement exactly, versus 0: the system doesn’t meet
that requirement). So, if you use some sort of rating system
like this, you’ll sure to ensure objectivity and a system that truly meets your needs will,
hopefully, present itself through that process. Once you’ve selected your system, your implementation
options, it’s time to determine your implementation strategy. For implementations that involve anything
beyond using the system out-of-the-box, there’s always the question of being Big-Bang or phased
approach. The Big-Bang approach is enticing, because
it means you get everything you need all at once, but it also means a large investment
and also there’s a longer waiting before you actually get to use the system  before
your end users get to use the system. Also, we found that once users begin to use
the system in their day-to-day life, they usually discover additional requirements as
they start to use it and become familiar with it. The Bog-Bang approach, generally, depletes
the budget for future enhancement  at the least for a while  so, the users would
have to wait longer for this additional requirements typically. We have had a few early adopters of Siebel
CTMS that took on the Big-Bang approach, in which they included application enhancement,
data integration, data migration and system automation components. These projects are pretty large  in some
cases over a year or longer  to deploy the initial phase, but since — And also since
data integration and other components are dependent on the base of application functionality
and it ended up being like trying to hit a moving target in completing those aspects
of the project, so it can lead to sort of multiple iterations. Also, again, once they deployed the system,
the users tried to use it for a few months and the users came up eventually with additional
requirements for enhancements, that not only effect the base application functionality
but the need to potentially update interfaces, as well. We usually recommend that you plan for a phased
implementation. This strategy allows your core business (or
your critical business) to be addressed in the initial phase very, very quickly and then
requirements to be refined at the beginning of each subsequent phase, based on the influence
from experienced users of the system. Also, this allows for a stable CTMS system
to then build integrations in a phase two or subsequent phase scenario. In addition to the flexibility this strategy
provides, user feedback is generally more positive with this approach. As is user adoption, because new tools and
prostheses are easier to accept in smaller chunk. The more quickly your users master the new
system the faster you can see a sort of return on investment. But the phased approach alone doesn’t necessarily
guarantee success. There is a lot more work to be done, well
in advance to your go live date, to ensure a smooth transition to your new system. So, let’s look at some best practices for
before implementation. Prior to beginning your implementation, here
are some steps that we recommend you take: assembling your project team and making sure
you include, again, representatives from all of the stakeholder groups, including IT and
each area of the business that will be affected by the new system; determine who is going
to lead the project, who will have the authority to make decisions, who is going to be part
of the new team, who is going to be part of the extended team; define how often the core
and extended teams will meet and how much time in between meetings each member will
be expected to work on that project; write all of that down to adhere to a project charter
and have the team formally agree to it. For team members, who are non managers, consider
having their managers approve their employees’ time commitment, as well, to the project,
in addition to their day jobs. You have to determine the tasks, the deliverables,
deadlines, responsible resources. Be sure to include all of the tasks that we
mentioned in the best practices, not just typical system development lifecycle and validation
tasks. There’s a lot more than just that. Scope control plan: it’s incredibly easy
for the project’s scope to their implementation, especially a long project, so that’s why
you should come up with a strategy for handling ahead of time, with a formal process or requesting
reviewing and approving scope changes, like additional requirements, you can ensure that
all that down effects are considered and only business critical changes are allowed in that
process. You want to design your communication plan,
you know, consider all your audiences for that project, the topics and level of detail
they’re going to jerk on and the best method of reaching them during that implementation
and the frequency with which they should be updated. You also want to begin your SOP gaping out,
so, once you’ve selected your system, you should have enough information to begin analyzing
your SOPs and identifying the gaps. And I’m sure that you’ll all agree that
the SOP offering review and approval process can sometimes be quite long, so, it’s best
to start working on that task as earlier as possible. You also want to begin analyzing your organizational
structure. So, with the introduction of the new system,
the structure of the organization around it will most likely change. It’s best to start considering these changes
early, so you can, again, identify the gaps and begin figuring out who will fill those
gaps. A key consideration for a CTMS implementation
is really how the administration tasks will be handled (will they be centralized or be
centralized within the application). We generally find that a centralized approach
works well, but it truly depends on your specific organization culture and needs. Once you’ve created your formal plans or
managing your project, it’s really important to stick with them, that way everyone involved
will know exactly what to expect and what is expected of them. But it’s also wise to consider your communication
plan  you know, a living document, so that you’re able to make adjustments when you
receive feedback that the communication is too frequent or infrequent, too high level,
too detailed. Once that project is under way, it’s time
to design your rollout training and support plans, as well. Are you planning to release the use of the
system to all of the users all at once? Are you going to potentially pilot a study? Will you cut over studies that are already
in progress, or will you maintain two systems for a while? Once you determine your rollout plan, you
can begin formulating your training plan. If all the users will go live at once, you’ll
need a plan for training all at once! If you make the transition study-by-study,
you might want to train one study team at a time! So, again, once you determine who you’ll
be training and when, you can decide which message in the material would be most effective,
based on, again, organizational culture and the characteristics of your user groups. The post go-live support plan should include
multiple level groups of support. We often see clients identify a super user
in each of the business areas, which serves at their first year of support for the user’s
respective area (for basic sort of “how do I do” in the system) and then it will
be followed in in-house helpdesk support and then external support, provided by your implementation
partner or your system vendor. But beyond identifying these, the support
plan should also consider how to maximize the help tools that are built into the system,
as well as additional trade acquisition (like job base and refresher training and things
like that) and how frequently those approaches are utilized. I think that the rollout and support plans
are very much linked together, so, that requires a lot of careful thought and consideration
for you to support both the immediate and long term success of the project. Another best practice is related to user adoption. Involve your users early and often not only
should they be involved in the selection process and the project team, in addition to be involved
in design workshops, document reviews, test executions; you can also consider having a
sandbox environment installed as early as possible with the caviar that your development,
if you’re doing development, will be ongoing. So, you have to manage around that, but also
plan to have everyone who will be involved in test executions formally trained prior
to testing. They don’t necessarily need to be trained
on the sample system, but at least trained for test execution. So, that’s going to ensure a smoother testing
process and minimize any anxiety in the testers. For example, if they don’t know how to use
the system and they struggle with one of the test steps, they may develop a negative view
of the system and become resistant to adopting it. The sooner the users are exposed to the system,
the smoother the transition will be. As you can imagine, implementation of a new
system is a great time to review, or possibly create a data standards document, so, this
ensures that all users know how and in what format data should be entered in the system. The document should cover everything, from
what to enter in each line of the address record, for example, the expected usage of
abbreviations and the expected usage values in comments fields to the format of a site
number. So, we have scenarios where clients implemented
a new system, but didn’t take the time to develop clear standards for your data, so,
that lead to things like addresses that were a hundred names spelled out as G-R-E-E-T and
other addresses that were a hundred names straight with St. in the system. So, you’ll end up with duplicate data potentially
if you’re not adhering to those data standards. So, it’s important to do that. Or, some users for using address on two for
department name and a three for suite number and other users for using it sort of in reverse. So, you can imagine searching through a system
like that can be pretty frustrating, especially if you don’t know which field to search
on for a department name, for example, for that information. So, standardizing that data entry makes querying
for the data simpler and also reporting of the data much cleaner. Finally, prior to go live, it can be incredibly
helpful for a mandate from executive business resources, such as project sponsors, that
the CTMS must be used according to their pre-schedule and that the use of the legacy worksheets
and logs must be discontinued. So, the last thing that you want is investing
in a CTMS to centralize all of your data, but your users are still hanging on to their
spreadsheet. That’s something to address very early on
during that design process. You incorporate some of these important spreadsheets
and make them tracking into your system and make sure that users are bonding to that. That’s probably one of the biggest reasons
for low user adoption for new systems. If there’s no clear directive that at a
certain date old ways of tracking should be discontinued, users will continue using them. But if it’s clear that the expectation of
everyone from senior leadership is to use the system, user adoption is no longer an
issue. So, that’s really important! So, those are our best practices, hopefully,
you can hope for, prior to implementation or during the implementation… Things to consider when looking at a CTMS! So, hopefully that’s been helpful. And with that I will now open up the session
to any questions that you may have. And, again, the best method is to use the
chat feature. If you do have any questions, please enter
them in the chat and then we’ll address them as we have time. Thank you. Eugene, do we have any questions? Yeah, so far we have one question that relates
to TMF, but you can go ahead and answer it to make sense. “Is there any one particular best way to
shift from a complete TMF system to a completely electronic one?” And you might want to answer that as either
CTMS or TMF, however it shows best. So, we get this question a lot and I don’t
think there’s any best way or best solution to sort of go to an eTMF fully electronic
Trial Master File system. Your CTMS is not going to cover it, so, typically
your CTMS is not going to have a component of electronic Trail Master File; but it does
integrate very well with eTMF solutions. So, there’s a variety of eTMF solutions
that are available, or you can utilize content management exclusions for eTMF and the integrations
that work well is when you’re tracking– Because you are tracking the lifecycle of
those documents before they’re in their final state, right? You’re tracking all of that information
in CTMS from a document tracking perspective (what you accept to the site, what the site
has come back to you, what’s been approved, what’s been signed, expired…you know,
all of that!). So, all of your site documents are actually
tracked within CTMS, but the actual physical storage of that document is going to be in
your TMF solution. So, whatever document management system that
you are using, or eTMF system you are using, you will want to integrate your document tracking
records within CTMs  or your document tracking module within CTMS  and the physical location
of that document, to really give it the best visibility to your study team. If you’re tracking the document in CTMS,
you’ll have a link potentially to CTMS, where you click on it and it will open up
your eTMF and you can actually see that stored version of the approved, scanned document. So, that’s the way to sort of close the
loop and integrate both of those solutions. You’re not going to want to use your CTMS
to store documents, but you want to integrate between the two. Great, thank you! The next question is: “How does this CTMS
system generate queries? Or, are queries manually created by reviewing
listings? A well programmed query system is well preferred.” Okay. So, if we’re talking about searching to
the system, most CTMS systems  including Siebel  have a very robust way of querying
the data across all of the measures that we talked about, that can be tracked within Siebel. There is ability to have personal queries,
as well as phased queries for the organization. So, if you have a standard programmable need
to have, global queries are set up to be able to be used, this system allows you to do that. That’s one of the main benefits of the system:
that you are able to get the data out of the system very, very effectively. If we’re talking about specifically queries
from that data management perspective, that’s typically not within the scope of the CTMS. So, that’s going to be, you know, your data
management system to looking at sort of adopting any queries. I hope I answered that question. Great, thanks! The next question is quite subjective and
fell free to answer it  or phrase it… “What are the strong points of CTMS compared
to IMPACT?” So, I assume that question is strong points
of Siebel CTMS as compared to the IMPACT CTMS solution. What I will say is that, in terms of the main
reasons that we feel…that we find that clients are choosing Siebel CTMS over some of the
other systems that are available, is for a few reasons: 1) it’s obviously the leader
in the CTMS space, so, if you talk about the number of users that are using Siebel CTMS
versus any other solution out there, it’s number one! You know, Oracle has made significant investments
recently into the CTMS product and they continue to do so, so, that’s obviously evident in
Oracle investment into the system, to continue to keep it updated. The other couple of reasons that I think are
really strong is, you know, Siebel is a very openly architected system, so, what I mean
by that is that it’s scalable, it’s configurable, it’s not sort of rigid in the way that you
have to use it. You can configure it; it’s very flexible;
it’s openly architected for you to actually make changes to the system using the inherit
tools of the system. And the other thing around openly architected
is the fact of integration. So, from an integration sampling I think the
system is very powerful. You can integrate the system with virtually
any other system out there and there’s inherit integration tools into the solution to handle
real-time integrations, web services, as well as integration and sort of automating all
of that. There’s a variety of different mechanisms
and approaches that come with the system, to be able to integrate it. And obviously, I mentioned earlier about being
scalable. So, you want a system that is going to not
only handle your needs today, but it’s going to be able to scale as your organization grows
inside a users’ base. It scales really well from a hardware perspective,
but also from a functionalities perspective, you’re able to sort of build on it and the
system is designed to evolve with your business needs and your functionality needs. So, that’s really what the key drivers are,
that we feel that our clients are choosing Siebel over some of the other CTMS systems
that are available. Great, thank you! The next question we have is: “How does
Siebel deal with early phase or stage one studies?” We have had organizations that use Siebel
for early phase and stage one studies. There are some challenges with the out-of-the-box
version of it. Obviously, phase one studies are — There’s
a lot more compacted in time when you’re talking about with phase one studies and what
you need to track and it’s more timely– It’s shorter time points that need to be
tracked, so, that becomes a little bit of a challenge. Also, tracking things like the number of beds
that are available in various clinics and what’s being utilized, we’ve had requirements
around that from a phase one standpoint and that’s something that we can configure within
the system to be able to do that, but out-of-the-box with the standard system or with the accelerator
it really doesn’t handle sort of tracking of those types of resources. So, the whole capability of what phase one
studies need, in terms of resource management…there are some challenges with that; but if you’re
looking for a study to consolidate all of your study tracking needs (along with your
phase two, phase three, phase four studies) and try to keep them all together, Siebel
CTMS offers that very well. But, you know, you’re going to have to potentially
configure it if you want anything more than that. Great, thank you! The next question is: “Do you offer Webinar
demos of Siebel CTMS?” In some of our Webinars, where we’re talking
about specific functionalities, we do demos of our accelerator solutions or of Siebel. So, last month we did a Webinar specifically
on monitoring or trip report and electronic signature and the whole review and approval
process. So, during that Webinar we did go into the
demo of the system. We also did a demo of the latest version of
Siebel and some of the key features of Siebel 1.11 and Open UI, so, we do offer that. If you look at some of our recorded Webinars,
you’ll see some demos of some of that functionality; but if you’re looking for an in-depth demo
your organization specifically, we’re happy to do that, as well. You can reach out to us and we’re happy
to schedule more of a targeted demo with your organization and actually go through that,
with your questions and concerns and business approaches in mind. Okay…So, we just got a very long question
here, so, I think this will be our last question: “What approaches can be used to reduce duplication
of data in CTMS? Often, we see the same clinic reference in
different ways (for example, the address is slightly different and for one instance it
uses abbreviations for words and one does not). This creates multiple records for, essentially,
the same site. It’s a data maintenance problem and it can
cause problems with integrating with other systems.” That’s a very common concern and the data
standard documents, that I mentioned earlier, really address a lot of that. So, when we implement the solution the investigator
database, the accounts database  you know, when we’re talking about doctors and addresses
and clinics and hospitals  it’s essentially reference data that’s going to be utilized
on multiple studies, potentially. Yes, you do not want duplication of that data,
duplication of addresses and things like that. So, the first thing that we want to do is
implement a data standards document, so you don’t have situations where it’s a hundred
name “S-T-R-E-E-T” and the next time you add the address it’s a hundred name “St.”. So, the data standards, if you’re following
that  for example, if you employ the standard addresses the way they’re set up by the
United States Postal Service, they have a standard way of doing those abbreviations
and things like that. So, if you employ that, that will address
a lot of your concerns on duplication of data or where the addresses are slightly different. The second way that we recommend to doing
that is centralizing the update and editions to back-reference data. So, you don’t necessarily want all of your
end users to be able to entering new contacts and new accounts and new addresses in the
system. So, if you centralize that process, you’re
using reference data, so, it’s an end users who’s using “Dr. Jones” as an address
for them, and the address changes and they just overwrite that address and put the new
address in there. You’re essentially changing it for everybody. Those are globally referenced data. So, they just change that address for everyone
that utilizes “Dr. Jones” on their studies. So, you want to potentially centralize that
update and editions to that data, so, you’re limiting the folks that are entering that
reference data, to maintain a little bit more data integrity and if there’s a request
upon a new doctor in there, your centralized group at least will query the system and make
sure that Dr. Jones does or does not already in the system before entering them in. So, that’s the second way. Third thing is there are some de-duplication
modules that are available within for Siebel, so that when you do enter a data that looks
like it could be a duplicate, the system will potentially let you know that “This may
be a potential duplicate. Are you sure you want to enter it?” We haven’t seen that utilized very heavily
with CTMS, because when we’re talking about CTMS it’s not that extensive of a database
when we’re talking about contacts, but it’s something that utilizes financial services
or communication hi-tech on the Siebel site where have millions of records. So, that is another option. But one of the things that works really, really
well within Siebel and is inherited to the application is the ability to merge records. So, on a regular basis, if you look at addresses
and look at contacts and accounts and you recognize that they are duplicates, the last
thing you want to do is delete a duplicate; because that duplicate might be associated
to a site or a study. So, there is a concept of merging records. Merging in the system allows you to take two
(or three, or four, or five) records and merge them into one golden record and it retains
the association to child records and site records throughout the system. So, that works really, really well. There’s ways to maintain your data on a
regular basis and decrease the level of duplication and the level of replication of the data that’s
in your system. Great, thank you. We have several more questions. Unfortunately, we cannot get to them, since
the allotted time that we have for this Webinar is up. If you do have other questions, feel free
to email Param and we can get some answers back to you. Just as a reminder, this Webinar is being
recorded and will be sent to you within several days, along with the PowerPoint presentation
in PDF form. We have several upcoming Webinars that you
can register. Feel free to visit and you
can see the entire list of upcoming events. We’d like to thank you very much for your
participation and we hope that the information we provided you today was helpful. Have a great rest of the day and evening. Thank you!

1 comment

  1. Not sure why no likes, but i found it very helpful! Im a phd student looking to obtain a cra position…no luck so far but who knows!

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