Presented at the CBI Conference; August 20, 2013 by Manny Tzavlakis, Joseph Morrell, and Ben Yao.
Text of Clinical Data Capture
1. Clinical Data Capture CBI Conference; August 20, 2013
2. Speakers Ben Yao Associate Huron Life Sciences Manny Tzavlakis Managing Director Huron Life Sciences 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Joseph Morrell Manager Huron Life Sciences
3. Agenda Considerations for Capturing Clinical Data from Third Parties Using Technology to Facilitate Data Capture New Possibilities Q&A 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
4. Considerations for Capturing Clinical Trial Payment Data
5. 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Capturing clinical data from third parties: Contract Research Organizations (CROs), Academic Research Organizations (AROs), Site Management Organizations (SMOs), is a challenge for many manufacturers. Considerations for successful clinical spend data capture: Establish Business Requirements Work with internal compliance/legal to determine baseline requirements for capture of clinical trial payment data. Confer with relevant functional units (e.g. various therapeutic areas, global vs. US, etc.) to determine data formats across units as well as additional data to be gathered for business purposes. Finalize Technical Requirements Determine which systems will be impacted by the clinical trial business requirements. Document technical requirements for existing (e.g. Accounts Payable, Customer Master, Reporting Warehouse) and new (e.g. CRO data capture system) systems. Develop Business Processes Identify resources to provide CROs with updated trial information and to manage error resolution. Update business processes to ensure that all necessary data are included in site agreements or other study startup documentation. Ensure that resources and processes for reviewing data and managing disputes are in place. Considerations for Capturing Clinical Trial Data DEVELOPING REQUIREMENTS AND UPDATING PROCESSES
6. 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Considerations for Capturing Clinical Trial Data DEVELOPING REQUIREMENTS AND UPDATING PROCESSES When developing requirements for capturing clinical trial payment aggregate spend data, one of the primary goals should be to enhance data consistency across all third parties and internal Accounts Payable. Consistent identification of investigators, sites, trials, and compound codes will be essential for efficient generation of aggregate spend reports.
7. 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Considerations for Capturing Clinical Trial Data DEVELOPING REQUIREMENTS AND UPDATING PROCESSES When developing business and technical requirements, a manufacturer should consider that different business units may: Have different formats for data such as site number, protocol/trial number, etc., or may or may not use some of these data elements consistently In limited cases such as certain post-marketing studies, have more than one principal investigator Utilize different types of healthcare professionals (e.g. doctors, PhDs, dieticians, or others) as investigators Issue payments to investigators via investigator sponsored trial payments When developing processes, consider that: Different business units may contract with sites in different ways (e.g. directly or via CROs or other contracting vendors) Processes must be established to account for when a principal investigator at a given study site changes
8. Using Technology to Facilitate Data Capture: One Solution
9. 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Using Technology to Facilitate Data Capture DEVELOPING ONE SOURCE OF CLINICAL TRIAL SITE PAYMENT DATA In general, clinical trial site payment data will be housed in a variety of systems across: Manufacturers should consider deploying one system to consolidate this data to promote: The data consistency described previously. The ability to aggregate, review, and analyze data by investigator, site, or compound. The ability to monitor the compliance of CROs with the manufacturers reporting deadlines. A single source of clinical trial payment data for integration into the manufacturers existing aggregate spend reporting architecture.
10. 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Using Technology to Facilitate Data Capture Principles of the CRO Data Capture System Develop standard Excel/flat file templates that are acceptable to all business and geographic regions; deploy this template to all CROs and mandate compliance with the data requirements. Establish a consistent reporting and error resolution schedule across all CROs. Validate data against business rules prior to processing into the aggregate spend architecture. Provide a single source of clinical trial site payment data for aggregate spend reporting purposes. BENEFITS OF CENTRALIZED CLINICAL TRIAL PAYMENT DATA
11. Using Technology to Facilitate Data Capture If a CRO submits a record that does not match your master list of: Trials Compounds Investigators Sites That record will be returned to the relevant CRO for correction. This validation will help reduce data errors within a manufacturers aggregate spend architecture. The CRO Data Capture System will also monitor to ensure that CROs submit data in accordance with the manufacturers guidelines. CROs that do not meet timing guidelines will be alerted by the System. BENEFITS OF CENTRALIZED CLINICAL TRIAL PAYMENT DATA: VALIDATION
12. Using Technology to Facilitate Data Capture OPTIONAL CUSTOMER STANDARDIZATION AND MATCHING FUNCTIONALITY If a CRO submits a record that does not match your master list of: Investigators Sites (Organizations) That record can be automatically standardized and matched against your master list and either assigned to an existing master unique ID or sent for manual resolution. CROs are notified of resolved records to reduce subsequent errors. Records that are of very low quality will be returned to the CRO for correction and re- submission. Customer matching will reduce the volume of errors going back to the CROs when a unique ID has not been provided
13. Key Challenges & Best Practices CAPTURING CLINICAL PAYMENTS 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. Selected Key Challenges Navigation of the complexity of reporting relationships (e.g. research chain scenarios with downstream payments) Engagement with third parties who utilize non-traditional research methods (e.g. SMOs and AROs); getting buyoff and cooperation with frequent and accurate reporting Integration of third party systems, data structure and processes to align with reporting process Best Practices Data capture in upstream business processes to accommodate consistent business rules at a later stage Creation and utilization of a centralized customer master to track both HCP and HCO spend across the organization; shared customer IDs with third party partners Early and frequent onboarding for third party partners to ensure buy-in, organizational support, and solution identification. Continuous and open communication amongst stakeholders
14. New Possibilities
15. Healthcare Practitioners (HCPs) involved in Clinical Trials are expected to decrease between 25 50% due to the Open Payments Act according to ASCO With limited Clinical Key Opinion Leaders (KOLs), manufacturers will be competing for a smaller number of investigators and specialists Utilizing the data store created by capturing Clinical Transparency information, manufacturers can build new data models to determine where KOLs can be more effectively utilized within an organization, particularly in various specialty markets Clean data is t