Sharing CTMS DataBetween Sponsors and CROsJune 21, 2012Param SinghVice President ofClinical Trial Management SolutionsBioPharm Systems, Inc.
Welcome & IntroductionsParam SinghVice President ofClinical Trial Management Solutions• 4+ years with BioPharm• 11+ years of experienceimplementing Siebel Clinical• 15+ Siebel Clinical implementations
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 AgendaTime (CDT) Topic9:00-9:10 Welcome and Introductions9:10-9:15 Clinical Trial Management Outsourcing Trend9:15-9:20 Key Considerations for Data Sharing Methods9:20-9:40 Discussion of Data Sharing Methods:1. CRO Export / Sponsor Import2. CRO Access to Sponsor CTMS3. CRO-Sponsor CTMS Integration9:40-9:45 Scenario-Based Analysis of Data Sharing Methods9:45-10:00 Q&A
Current Industry Trends• Rising costs of drug development– Average $4 billion per approved drug• Government pressure to lower health care costs– One of the priorities of the Obama Administration• Increased FDA scrutiny for product safety and uniqueness– Must be unquestionably safe and significantly different• Greater demand for post-market studies– Long, complex, and expensive• Competition from generics– Several expiring patents
Clinical Trial Management Outsourcing Trend• Largest expense in drug development process:clinical trials– Account for nearly 70% of the total research anddevelopment costs• Most effective ways to lower costs:1. Implement technology solutions2. Outsource• As of 2010, 50% of clinical trial activities are beingoutsourced
Clinical Trial Management Outsourcing Trend• Total spending on CROs:– $9.8 billion in 2001– $15 billion in 2007– $24 billion in 2010• Increasingly important role of CROs results in needfor greater collaboration between sponsors andCROs– “A balance that includes ongoing communication, timelyaccess to data by sponsors, and project updates must bemaintained in order to achieve successful relationships.”-- Frost & Sullivan Research Analyst, Rinat Ariely
Choosing a Data Sharing Method: Key Considerations• Data Turnaround– How quickly sponsor needs clean data available to them• Resources– Sponsor/CRO resources available for scrubbing and/or converting data– Sponsor resources available for training CRO users of CTMS• Budget– Human resources, software licenses, system integrations• Work Volume– Number of CROs involved, number of resources involved at each CRO,number of studies being outsourced, complexity of studies
Method 1: CRO Export / Sponsor ImportData is entered into the CRO CTMS, scrubbed by the CRO, exportedfrom the CRO CTMS, converted to fit the sponsor CTMSrequirements, and imported into the sponsor CTMS.**Process takes place for each data update for each outsourced studyData Entry inCRO CTMSData Scrubbing byCROExport fromCRO CTMSDataConversionData Import intoSponsor CTMS
Method 1: CRO Export / Sponsor ImportBenefits• Inexpensive• Easy to modify export/import formats• Minimal technical skills required• Low risk of sharing unclean data• Low risk of sharing confidential data
Method 1: CRO Export / Sponsor ImportDrawbacks• Data updates depend on clear communication between sponsorand CRO in an often hectic environment• Mostly manual process– Need personnel and time to scrub and convert data before each importfor each outsourced study• No automated data validation prior to importing– Potential for large number of errors to be investigated and corrected• Data availability to sponsor can have long turnaround times• Never any real-time data in sponsor CTMS
Method 2: CRO Access to Sponsor CTMSCreate Roles• Create user roles in sponsor CTMS• For each type of contracted resource performing data entryCreateAccounts• Create accounts and assign roles to accounts• For each contractor; at each CROProvideCredentials• Provide usernames and passwords• To each contractor; at each CRODirect DataEntry• Each CRO contractor enters data directly into sponsor CTMS
Method 2: CRO Access to Sponsor CTMSBenefits• No technical skills required; only the ability to usethe sponsor CTMS• No export/import necessary• No integration costs to incur• No error logs to investigate and resolve• All data is real-time in sponsor CTMS
Method 2: CRO Access to Sponsor CTMSDrawbacks• Requires time and resources to train personnel at each CRO• Per-user license costs can be quite expensive• Increases burden on CTMS Administrators to manage user rolesand accounts• Data standards can be difficult to enforce• No opportunity for CRO to review data before it is madeavailable to sponsor• No error logs generated; errors must be found manually• Mistakes must be corrected in sponsor’s production CTMS
Method 3: CRO-Sponsor CTMS Integration• Sponsor defines desired:– Data points– Business rules• Sponsor CTMS integrated with each CRO CTMSCRO CTMS’s•Data entryIntegration Interface•Pre-defined data points•Business rulesSponsor CTMS•Auto-populated•No human intervention
Method 3: CRO-Sponsor CTMS IntegrationBenefits• Scalable solution– No need to train CRO personnel on CTMS use; CRO resources can scaleup, scale down, or change as needed without impacting data sharing– If designed in standard format, can be used with as many CROs as desired• Saves time otherwise spent on data entry, data conversions, etc.• Ensures higher data quality across all studies and integrated CROpartners• Automatically checks for errors; sends notifications when found• Provides clean data to sponsor as quickly as desired– Interface schedule is determined by sponsor
Method 3: CRO-Sponsor CTMS IntegrationDrawbacks• Can be expensive to implement• CRO and sponsor resources still required to address errors• Requires CRO agreement and cooperation• If not designed using a standard format, could lock sponsor intousing specific CROs
Scenario-Based Analysis of Data Sharing MethodsScenario“Superdrug” is a medium-sized pharmaceutical company with twoproducts in the market and a handful of promising compounds inthe pipeline. They currently manage all of their clinical trialsin-house using Siebel Clinical, but they realized a few months agothat that model will not support their anticipated growth. So theyunderwent the process of identifying and qualifying CROs, and theyhave selected 3 finalists. They are now trying to decide the bestmethod for collecting their CTMS data from these new partners.
Scenario-Based Analysis of Data Sharing MethodsAnalysis of Key ConsiderationsConsideration Superdrug’s SituationData Turnaround Need data within 48 hours, but prefer to have it sooner.Resources Limited internal resources available to deliver training; not avery tech savvy group; minimal support from IT department.Budget Modest budget available, but required to provide air-tightbusiness case for every major expenditure.Work Volume All pipeline drugs are first-in-science, so upcoming trials willbe long and complex; anticipating needing intense, lengthysupport from CRO partners.
Scenario-Based Analysis of Data Sharing MethodsSelected Method: CRO-Sponsor CTMS Integration• Send RFPs to 3 finalist CROs– Integration plan– Reduced rates for long-term, exclusive contracts– Include SLAs• Use best proposal to draft business case for integration– Include savings projections– Emphasize scalability, efficiencies, and data quality• Once approved, choose an integration vendor who will build theintegration in a standard format that can be used with any CRO