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!