Top 10 Reasons Why You Need a CTMS

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  • 1. Top 10 Reasons WhyYou Need a CTMSParam Singh

2. Welcome & IntroductionsParam SinghVice President ofClinical Trial Management Solutions 10+ years of experienceimplementing Siebel Clinical Managed over a dozen Siebel Clinicalimplementations 3. Welcome & IntroductionsCTMS Practice ServicesImplementationManage implementationsof Siebel Clinical, whethercustom builds or ourout-of-the-boxaccelerator, ASCEND.IntegrationBuild interfaces betweenSiebel Clinical and otherclinical systems.TrainingDevelop and/or deliverstandard and customtraining classes andmaterialsProcess GuidanceProvide insight, advice,and solutions to specificCTMS issues based onindustry best practices. 4. Todays AgendaTime (CDT) Topic9:00-9:05 Welcome and Introductions9:05-9:30 Count Down of Top 10 ReasonsWhy You Need a CTMS9:30-9:45 Live Demonstration of 2 Features,Voted on by You9:45-10:00 Q&A 5. Reason #10Simpler MaintenanceMaintain one commercial system,usually with support from the vendor,rather than multiple spreadsheetsand/or home-grown databases. 6. Reason #10: Why? Minimal duplicate data entry anderror resolution No confusion about the storedlocation or most current version No need to maintain expertise inhouse; rely on vendor Vendor supplies updates, patches, andbug fixes Hosting makes it even simpler; noneed to maintain IT infrastructure 7. Reason #9Centralized Investigator DatabaseStore past, present, and futureinvestigator information in a centrallocation that can bequeried duringsite selection. 8. Reason #9: Why? One master record with multipleread-only associations People, organizations, and addresses arestored separately and then associated toone another as appropriate Centralized maintenance = cleanerdata Can capture additional metadatafrom standardized dropdown lists Easier to query 9. Reason #8Transparent Financial TrackingMonitor planned costs vs. actual spendvs. outstanding balances forinvestigators, sites, sponsors, andvendors. 10. Reason #8: Why? Investigator payments, IRB fees,vendor expenses, etc. in one placeprovides a comprehensive picture Enforces business rules and SOXcompliance through paymentstatuses that can only be updated byauthorized users Helps to identify potential costsavings and to plan better for futuretrials 11. Reason #7Streamlined Document TrackingCreate standardized lists of documentsto be collected over the course ofvarious types of trials, and trackstandardized dates andother informationagainst those lists. 12. Reason #7: Why? Enforces standardization andconsistency in the informationgathered and the method forgathering it Allows users to update multipledocument records and/or fieldssimultaneously Enables quick identification ofdocuments that are still outstanding,expired, about to expire, etc. 13. Reason #6Increased Recruitment VisibilityTrack subject enrollmentacross studies andclinical programsagainst planned targets. 14. Reason #6: Why? Identify high- vs. low-performinginvestigators Learn which sites are experiencingthe greatest number of screenfailures and early terminations and why Capture metrics on planned vs.actual recruitment Accurately plan monitoring resources 15. Reason #5Ability to IntegrateStreamline processes even furtherthrough automated interfaceswith other clinicalsystems. 16. Reason #5: Why? One source system for each kind ofclinical data Fewer data entry/maintenanceresources needed Less data investigation andcorrection needed No need to log into multiple systemsto find answers Processes are completed consistentlyand quickly 17. Reason #4Greater ComplianceAdhere to regulatory requirements andguidelines through user accesscontrols, enforced processes, andbehind-the-scenestracking, such asaudit trails. 18. Reason #4: Why? Much easier to validate and keepvalidated/controlled thanspreadsheets Much easier to control access:system as a whole and specificrecords Fewer deviations Greater data integrity Smoother audits 19. Reason #3Robust ReportingAnswer questions quickly and easilywith ad hoc and canned reportsthat query onecentralized database. 20. Reason #3: Why? Stores historical and current data Stores ALL clinical trial data, fromsubject recruitment to vendorpayments to investigator information Offers high level and detailedreporting capabilities Provides access to real-time data,especially with integrations; no moreout-dated reports 21. Reason #2Informed Decision-MakingIdentify trends and inconsistenciesacross investigators,trials, and businessunits. 22. Reason #2: Why? Real-time, comprehensive dataenables nimble, smart decision-making Identify strengths and weaknessesin PIs, vendors, and even your ownorganization Identify areas of risk and putprocesses in place to mitigate Make changes to current trials andplan better for future trials 23. Reason #1Scalable GrowthIncrease the number and size of thetrials you manage with fewer additionalresources. 24. Reason #1: Why? No organization can afford to spendexponentially to grow exponentially Scalable software solutions are theanswer CTMS consolidates and streamlinessubject tracking, investigatorpayments, document tracking,financial tracking, site monitoring,and more, allowing you to managemore and larger trials with less 25. Top 10 Reasons Why YouNeed a CTMS10. Simpler Maintenance9. Centralized Investigator Database8. Transparent Financial Tracking7. Streamlined Document Tracking6. Increased Recruitment Visibility5. Ability to Integrate4. Greater Compliance3. Robust Reporting2. Informed Decision-Making1. Scalable Growth 26. Cast Your Vote!Possible Choices: Clinical Administration - Study Setup Investigator Payments Protocol Expense Tracking Document Tracking and Document Packages Investigator Database Site Setup Site Management Subject Tracking and Recruitment Visibility SOP Compliance and Templates System Reporting 27. Siebel Clinical ASCEND 28. Q&A 29. ClosingThank you for attending!This webinar will be posted onwww.biopharm.comwithin 24 hourspsingh@biopharm.com+1 877-654-0033+44 (0) 1865 910200