Making the Move to an EnterpriseCTMS for Organizations of Any SizeAugust 23, 2012Param SinghVice President ofClinical Trial Management SolutionsBioPharm Systems, Inc.
Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm Systems, Inc.• CTMS practice director since 2007– Expertise in managing all phases and styles of clinical trials– Leads the team that implements, supports, and enhances Oracle’s LabPasand Siebel Clinical solutions• Extensive Siebel Clinical implementation experience– 11+ years of experience implementing Siebel Clinical– 15+ implementations– Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND
Welcome & IntroductionsCTMS Practice ServicesImplementationsManage implementations of SiebelClinical, Siebel Clinical ASCEND, andOracle Health Sciences LabPas.IntegrationsBuild interfaces between Siebel Clinicalor LabPas and other clinical and non-clinical systems.TrainingDevelop and/or deliver standard andcustom training classes and materials.Process GuidanceProvide insight, advice, and solutionsto specific clinical trial managementissues.
Today’s Agenda• Welcome and Introductions• What Is an Enterprise CTMS• Key Indicators for a CTMS• Internal Analysis and Preparation• CTMS Selection Checklist• Q&A
What Is an Enterprise CTMS?• A single clinical trial management system that can be used bymultiple business units or clinical research divisions within acompany– Beneficial for sponsors, CROs and academic medical centers– Can be implemented organization-wide using a big bang approach or canbe rolled out using a phased approach• A centralized system for the management of all clinical trials– Eliminates disparate spreadsheets and databases across trials– Provides access to clinical trial information in real-time– Enforces consistency of administrative, operational and financial aspectsof trials across an organization
Could Your Company Benefit from an Enterprise CTMS?• Key indicators that a CTMS is needed– Rapid organizational growth– Increased clinical trial pipeline• Recent or planned merger of two organizations• Increased number, size and/or complexity of trials• Introduction or increased participation in global trials– Increased need for real-time trial information and reporting– Increased use of outsourcing to manage various trial activities– Inability to compare similar trials due to disparate methods of studytracking between trials
Could Your Company Benefit from an Enterprise CTMS?• Key indicators that a CTMS is needed (cont.)– Lack of a comprehensive investigator/site database with historical trialparticipation information– Desire to integrate trial management with other applications• Internal customer master systems, document management systems, EDC,IVRS, CDMS, safety, financial systems• External vendor systems– And much more…
Internal Analysis and Preparation• Current Trial Management Processes– Identify all divisions or business units currently performingclinical trials– Identify average number, size and length of on-going trials– Review how trials are being managed within the samedivision and across divisions• What types of worksheets and databases utilized?• Are standard management processes followed?• What documentation and reporting methods are used?• How are investigator and site payments tracked?
Internal Analysis and Preparation• Identify Stakeholders– What groups of individuals and functional areas will beaffected by the implementation of a CTMS?– Identify key business and IT resources for the CTMS projectcore team– Document roles and responsibilities of each member ofthe project team– Make sure that each team member will be able to devotethe amount of time necessary to make the projectsuccessful– Develop good communication tools
Internal Analysis and Preparation• Identify Critical Needs and System Requirements– Develop a comprehensive list of requirements for the organization’s CTMS• Solicit input from each group of stakeholders– Prioritize each requirement• Create a scorecard with each requirement listed as a 1, 2 or 3• Identify ‘Needs’ and ‘Must Haves’ vs. ‘Wants’
Internal Analysis and Preparation• Where Will the Money Come From?– Create a business case for presentation to upper management and otherstakeholders• Cost and time justifications• Key benefits of a CTMS• How the CTMS will be selected• How the CTMS will be implemented• An estimated timeline• Post-implementation costs– Obtain funding approval and management buy-in before moving forward
CTMS Selection Checklist System Identification– Become familiar with basic CTMS functionality and terminology• Internet search, webinars– Make a list of potential vendors and research their CTMS• Industry recommendations, conferences• Vendor websites, product data sheets– Narrow down the list of vendors• Phone conversations, remote demos, feature comparisons– Create and distribute an RFP– Based on responses, invite top 2-3 vendors to demo on-site
CTMS Selection Checklist Performance– Day-to-day routine use– Querying– Reporting– Large number of concurrent users Scalability– System needs to be able to handle increasedamounts of data as the company grows– Must be able to handle large numbers ofconcurrent users
Key Considerations in Choosing a CTMS Robustness– Select a CTMS with a wide range of capabilities that supports most if notall study management tasks Customization Options– Is the system an out-of-the box solution or can it be customized to meetthe company’s needs?– What types of customizations or configurations are possible?• New fields, label changes, workflows, additional functionality, etc.– Weigh the pros and cons of any customization↑ customization = ↑ cost– Affect on implementation timeline
Key Considerations in Choosing a CTMS Technical Considerations– Each CTMS vendor should be able to provide details regarding:• Technical architecture• Hardware and software specifications• Database sizing• Load balancing• Use of server virtualization• Performance tuning• Server monitoring• Database back-up and restore• Disaster recovery
Key Considerations in Choosing a CTMS Implementation Options– On-premises– Dedicated hosting– Shared hosting– SaaS Data Migration Analysis– Determine what data (if any) will be migrated from current systems orspreadsheets– Need for data cleansing– Data standardization across multiple sources– Cost analysis (programmatic migration vs. manual entry)
Key Considerations in Choosing a CTMS Integration Options– Identify the most useful and cost effectiveintegrations– Analyze integration methods– Perform cost – benefit analysis– Determine timing of integrations Implementation Partner– Software vendor– Implementation specialists
Key Considerations in Choosing a CTMS Training– Process/SOP revisions– Application training– Training tools Post-Implementation Support– Phone and e-mail support– Remote access– Knowledge base
Enterprise CTMS Conclusions• Key Indicators for a CTMS– Rapid organizational growth and/or increased clinical trial pipeline– Increased need for real-time trial information, a comprehensiveinvestigator database and the ability to compare similar trials– Desire to integrate with other applications• Internal Analysis and Preparation for a CTMS– Analyze current trial management processes– Identify critical needs and system requirements– Present business case and obtain funding
Enterprise CTMS Conclusions (cont.)• Considerations for CTMS Selection– System identification– Performance, scalability and robustness– Customization options– Technical considerations– Implementation options– Data migration analysis– Integration options– Implementation partner selection– Training and post-implementation support