Risks & Rewards of Upgrading to the Latest Version of Siebel CTMS
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Because Siebel Innovation Pack (IP) 2016 was such a significant departure from previous Siebel versions, our clinical operations team devoted much of last year to beta testing it, helping Oracle identify and iron out the kinks. Now that we have finished our assessment of the risks and rewards of upgrading Siebel Clinical to IP2016, we are ready to share them with you. In this SlideShare, Param Singh, director of clinical operations solutions, highlights not only the features and benefits of IP2016, but the risks involved in upgrading, including a look at computer system validation (CSV) and regulatory compliance issues. We also provide a sneak preview of IP2017, based on the insider information we receive as an Oracle Platinum Partner.
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Risks & Rewards of Upgrading to the Latest Version of Siebel CTMS
- 1. Risks & Rewards of Upgrading to the Latest Version of Siebel CTMS April 27, 2017
- 2. 2 About Perficient Perficient is the leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting, and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
- 3. 3 Perficient Profile Founded in 1997 Public, NASDAQ: PRFT 2016 revenue $487 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India Nearly 3,000 colleagues Dedicated solution practices ~95% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards
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- 5. 5 Today’s Presenter Param Singh • Director, Life Sciences • Leads clinical operations and connected health initiatives • 9 years with Perficient • 15+ years in life sciences 5
- 6. 6 • Why Oracle Siebel CTMS • Brief History of Siebel CTMS • IP2016 Platform-Wide Updates • IP2016 CTMS Specific Features • IP2017 Preview • Compliance Impact • Next Steps • Additional Resources Agenda
- 7. 7 Why Oracle Siebel CTMS • Thousands of seats deployed, support trials worldwide • Enterprise application and integration architecture • Global, scalable, proven • Adopted by top pharma/med device/CROs • Rich in features • Global trial support • Centralized investigator database • Real-time subject enrollment • CRA site visit planning, tracking & visit reporting • Streamlined payment generation & tracking • Provides users with relevant and timely information • Delivers trial information to CRAs and managers • Facilitates communications to the study team • Benefits achieved Better trial results Faster enrollment Improved investigator relationships Increased clinical research associate productivity Lower trial costs
- 8. 8 Brief History of Siebel CTMS • Built on Siebel CRM platform • Robust investigator database functionality • Historically, browser-dependent (Internet Explorer only) • Relied on ActiveX controls for high interactivity • De-supported due to security concerns • In the 2012 release, Siebel became browser-agnostic, referred to as “OpenUI” • Move to OpenUI enabled: • Browser independence • Multi-device support (tablets, smartphones, etc.) • Mobile rendering of applications • Usability focused features • Drag and drop attachments • Simplified search • Development extends to use of JavaScript and open source controls • What’s new in IP2016? What’s coming in IP2017?
- 9. 9 Platform-wide Updates Business Agility • Continued cross-browser support • NPAPI depreciation • Desktop integration Siebel Agent (DISA) • Microsoft Outlook Siebel add-in • Siebel application usage pattern capture • Standards-based REST interface provision fully within Siebel CRM Customer Experience • Additional OpenUI themes • Full UX design capability • Allows for UI to adhere to corporate web standards • Expose Siebel calendar as CalDAV server • Enhanced simplified search • Office 2016 certification
- 10. 10 CTMS-Specific Updates • Accelerated decision making via enhanced productivity • Batch processing of activities and documents across sites within a study • Batch payment generation for sites within a study • Subject transfers from site to site • Ability to track satellite sites • Support for planning and tracking clinical training • Support for split payments and multi payees for a site • Enabled for integration with Oracle Inform for subject and subject visit information • Some basic risk-based monitoring capability
- 11. 11 IP2017 Preview Agile Development • Multiple path development • Code branching • Users preview configurations Developer Productivity • Developer setup tasks pre-IP2017 • Developer VM • Install Siebel tools • Dedicated web client • Database extract • Full “Get” • No longer needed in IP2017 Built-in Automated Testing Capability • Record a user scenario, using a tool bar with Start, Pause, Resume, Stop and Annotate features • Store and organize the recorded scenarios in the Siebel CRM database • Play back the recorded scenarios in single or batch mode
- 12. 12 Compliance Impact • Moving away from back-end development • SRF is going away! • Moving toward application-level development • Similar to current LOV administration • Easier/faster to make changes to the application • Harder to control the changes made to the application • Application migration functionality will help • Setup > Configure > Plan > Execute • Process is audit trailed • Need strong procedural controls, including • Validating the new application migration functionality • Creating a standardized change impact assessment (don’t forget to consider integrations!) • Defining change types and determining who needs to approve what type of change • Implementing a consistent change-tracking mechanism
- 13. 13 Next Steps • If you haven’t already seen IP2016, request a demo • If you’ve seen it and want it, request an upgrade plan • Can include a move from on-premises to the cloud, including integrations • Can include data migration • Can include decommissioning of old/existing system • If you’ve seen it and aren’t sure it’s right for you, request a strategic discussion • If you have questions about IP2017, schedule a call • If you don’t have Siebel CTMS at all, request a demo Contact Param Singh directly: Param.Singh@Perficient.com
- 14. 14 • Simplify Your Life with Siebel CTMS | Download • Quick Guide to Planning Your Clinical Trial Management System Implementation | Download • Leveraging Siebel CTMS for Risk-Based Monitoring | View On Demand • 99+ Siebel CTMS Best Practices You Should Follow | View On Demand • 3 Ways to Implement a Clinical Trial Management System | View On Demand Additional Resources • Perficient.com/SocialMedia • Facebook.com/Perficient • Twitter.com/Perficient_LS • Blogs.perficient.com/LifeSciences
Hinweis der Redaktion
- Welcome from Eugene
- Eugene
- Eugene
- Eugene
- Eugene turns it over to Param
- Because Siebel Innovation Pack (IP) 2016 was such a significant departure from previous Siebel versions, our clinical operations team devoted much of last year to beta testing it, helping Oracle identify and iron out the kinks. Now that we have finished our assessment of the risks and rewards of upgrading Siebel Clinical to IP2016, we are ready to share them with you. Lets look at today’s Agenda: First because some folks on this call are not familiar with Siebel CTMS, we want to give an overview of Oracle’s Siebel CTMS system and its place in the market and impact on our industry. I will then go into a brief history of Siebel CTMS and its evolution as one of the leading CTMS solutions in the world, and go into some features and functionality that have been introduced over time in the product. Next we will start to highlight some features and functionality that were provide in last years release IP2016 which is now starting to get active use across companies. First we will discuss some platform wide updates in IP2016 that address usability and overall development approach across the platform. Then we will go into some specific CTMS specific features that have been introduced to address key requirements from a clinical operations standpoint. Next, Since IP2017 is set to be released soon, we will offer a sneak peak to some of the features and functionality that has been communicated to be released with the next version. And with what is planned for that release with regards to development and deployment approach for implementations, we will look at a potential approach to compliance and how this new quick deployment capabilities can potentially lower the compliance risk and in turn the validation overhead for an implementation. Finaly, we will look at what the next steps will be for your organization depending where you are on your journey in either identifying your needs for an enterprise clinical trial management system like Siebel CTMS or performing an upgrade analysis on your existing Siebel CTMS application to take advantage of the features we will be discussing today. We will end today’s call with a listing of some additional resources on the topic of implementing or upgrading your CTMS solution among other related topics. With that lets get started.
- Discuss positioning, what makes it the industry leader, and the high level key features/functions Why has Oracle Siebel CTMS enjoyed a leadership position in the industry for many years? There are thousands of seats of Siebel CTMS that are deployed worldwide that support many global trials. The functionality that this solution has has been the standard to measure other clinical trial management systems. One of the reasons it has been so successful establishing its position as a leader, is its enterprise application and integration architecture. Since organizations in our industry grow quickly both organically as well as through acquisitions, companies are looking for application that not only meet the clinical operational needs of today, but can scale and grow as the organization and its needs grow. This solution can be easily implemented for large organizations, but it can also be deployed in smaller mid sized organizations to give the same benefits without the risk of needing a different system as that organization grows. This is why it has been adopted by not only the top Pharma, Medical Device, and CRO organizations, but in recent years with the advent of Accelerators for Siebel CTMS, has been widely adopted by small and mid size companies as well. The system is rich is features you would expect from an enterprise CTMS to support global studies. It Comes with an integrated centralize investigator database to manage investigator relationship. Realtime subject enrollment tracing, full planning, tracing and completion of site visits and visit reports, and a very robust investigator payments generation modules. Having a centralized enterprise CTMs provides users with relevant and timely information, and delivers trial information to CRA, managers and executives, and helps facilitate communication across the study team. You can see some of the key benefits clients have achieved in using this system, which continues to keep it as one of the leaders in the industry.
- Built on Siebel CRM, Siebel CTMS when it was built already had the framework and foundation of a robust investigator database functionality to help manage the critical relationship with the investigators and sites. Obtaining requirements from key industry thought leaders, Clinical modules such as Protocol Builder, Trip Reports, Investigator Payments, Contracts, and Document Tracking were added to complete out a robust CTMS solution. While it was the leader in terms of functionality, one of the main critiques of the system was its browser independence on Microsofts Intenet Explorer. The web based system had a innovative high interactivity mode which allowed many interactive capabilities not available on other web based systems at the time, but those features relied on Activex controls for that high interactivity. Activex was recently desupported by Microsoft, so in 2012 Oracles response was the release of OpenUI., which was a platform wide change to the Siebel product, and the application became both browser agnostic, but retained some high interactivity like features that users were accustomed to. The move to Open UI, enabled several platform wide enhancements, the biggest and more widely acclaimed of them was of course the Browser independence. The ability to support all major browsers was a huge step in the right direction. Along with that, OpenUI now had multidevice support, across Tablets, Smartphones, and similar devices. Now that tablets, and smartphones outnumber traditional laptops and desktops, this was a needed evolution. Oracle even added with OpenUI the ability to render applications differently depending on which device is accessing the application, just as many websites do. Oracle also focused on enhancing Usability features that in previous versions may have been cumbersome. And added features like drag and drop attachments, and simplified “google-type” search across the application. A major shift that started with this release was the approach to development itself. Oracle started to move away from traditional development which was solely Siebel Tools driven and started to push some aspects of development to the application administration layer. This also allowed development to extend to the use of Javascript and open source control being able to be incorporated in the Siebel Applications. We will see that this shift is more pronounced in recent versions, but again this evolution started with the release of OpenUI, which started to show the direction Oracle wanted to take this platform. So, how has the product evolved since this introduction on Open UI. Lets take a look at what has been introduced in Innovation Pack 2016, and we can also preview some of the items that have been communicated to be coming in IP 2017.
- With IP 2016, we see oracle making platform wide enhancements that continue with the innovations that were introduced with the initialrelease of OpenUI.
- Again, one of the reasons that this product sit on the leaderboard with other CTMS solutions, is that Oracle continues to invest into the application to bring more innovative functionality the increases efficiency for Clinical Operations. Now let’s look at some of the CTMS specific enhancements that were made in IP2016 release or Oracle CTMS. First area is around accelerated decision making via enhanced productivity. While previous versions of the application allowed us to perform many activities at the Site Management level, this version brings added flexibility to allow for batch processing for sites across the study. One area is the batch processing of Activities and Documents across sites within a study. This allows users at the study level to create these records and select multiple sites to auto-create documents and activities for without having to get down to each individual site. Another common request we got in the past was related to batch payment processing. Typically, you get approval to generate payments for all sites, but in the previous application you only had the payment generation option at the site level, and now they have included batch payment generation at the study level to make that much easier. Next, in IP2016, oracle has added functionality to allow for transfers of subjects from site to site, and a running tally of transfers with transfer history. Next, in this version, you also have the ability to track satellite sites, along with regular site. Another key addition in this version is the ability to planning and tracking clinical training for studies. Going back to Payments, IP2016 allows support for multiple payees per site and per contract, which also allows for split payments and automatically incorporates that into the payment generation functionality. In addition to the application functionality for clinical operations, another major part of IP2016 is the enhanced out of the box integration with Inform to automatically bring in Subject and Subject visit information from CDMS. Lastly, with relation to CTMS updates in IP 2016, oracle has added some basic Risk Based Monitoring capability in CTMS which has seen recent interest across the industry.
- Under the category of Agile Development. At AFT Jennifer is working on fixing some Siebel base product defects. She has finished her development in the DEV and is getting ready to promote the code the QA system. Meanwhile, AFT has asked for some further changes in their DEV environment which they don't want to be included in Jennifer's release. Rene can't do this until after Jennifer's code has been migrated, otherwise his code will also be included. IP 2017 solves this problem by supporting code branching and allowing changes to be previewed by users without it being included in a distribution package. These and other features really support agile development ways that Siebel has never in the past. Developer Productivity In the past, we used to have to budget for at least 1 day of each developer to get their developer environment setup. These tasks included, setting up a developer VM, installing Siebel Tools, and the dedicated web client, running a DB extract, and performing a full database "get". No more! The moment that the server is delivered by the IT team, development can start. There is no Tools to install, no developer web client, no local database. All is now done in a browser based development environment. This allows for easy support of multiple clients in a single VM. (Oracle states that at initial release there may be a few specialized tasks that may still need to be done in Siebel Tools but the hope is that they quickly move these into the composer). Built in support for automated testing Innovation Pack 2017 will provide abilities to record user scenarios in the UI and play it back within the application at anytime. The playback will recreate the functional flow in same manner as users would interact with application, and detect any unintended regression behaviors. The recording of tests can be stored within the Siebel CRM application and used for validation when required. The results of running the tests also would be stored for analysis. The primary goal of these features is to significantly lower the costs of application testing and maintenance. The complexity of programming UI automation, costs of maintaining tools, tests and skills are eliminated. Test Automation enables the business users to record automated scenarios and tests, for demo and training purposes or for regression testing before rolling out releases. Following are the key features and abilities: » Record a user scenario, using a tool bar with Start, Pause, Resume, Stop and Annotate features » Store and organize the recorded scenarios in the Siebel CRM database » Playback the recorded scenarios in single or batch mode
- Param, for the bullet in red, this is base functionality, so we COULD take the approach that we assume Oracle did its own testing and everything works right…but my gut says this functionality is too important to NOT specifically validate. I’ll leave it up to you whether you want to leave the bullet in (and make it gray) or take it out.