04/10/2023 Veracity Logic, LLC 1

Overview of Company and Product Features

23 January 2014

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Company History• Based in Research Triangle Park, NC, USA• Incorporated and created first product in 2005• Developed Integrated Response Technology (IRT - both web and voice) for clinical trial

randomization and clinical supply management• David Goldston, CSV expert, joined management team in 2007• Deployed 15th study in 2009• Deployed 50th study in 2011• Deployed 75th study in 2013• Added development, validation, and project management staff in 2012• Mark Paul, CRO executive, joined management team in 2013

• Independent, management-owned, specialized provider of IRT systems for over 8 years

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IRT Product Experience• Used in over 80 clinical studies including:

>15,000 subjects, >2,000 sites, and> 5,000 users

• 40 Countries• 45 Languages• Multiple therapeutic areas• Integrated web and voice capability• Interfaces built for major EDC and ERP systems

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Key Product Features• Subject Management:

- Screening and screen failure tracking- Randomization (static, dynamic, and adaptive)- Drug assignment- Discontinuation/early termination- Stratification- Cohort management- Dose level titration

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Key Product Features• Clinical Trial Supplies Management:

- Tools for managing batches, supply sources, regions and depots (both central and regional) for a study

- Predictive re-supply model- Automated and manual shipment requests- Inventory tracking with triggers levels- Temperature deviation/excursion tracking- Kit management- Drug accountability- Expiry management- Inventory reports

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Key Product Features• Patient diaries and electronic patient-reported

outcomes (ePRO)- Web and phone options- Flexible collections methods- Dynamic branching with single/multiple choice

questions- Alerting, compliance reporting, and reminders- Outbound call/text capability

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Key Product Features• Standard Functions

- Data integration with EDC, lab, or ERP systems- Using real time web services or batch interfaces

- Data-on-Demand: data reports on each page- Global export to CSV function

- Context sensitive menus - Notes- Audit trail for record

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Reporting• VL system is based on ‘Live Reports’• All entry screens are reports• All screens can be filtered• Key reports include:

- Subject level visit report- Enrollment rollup report- Inventory report

• All screens can be exported to CSV/Excel format

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Electronic Data Capture Interaction• Web services (real time) XML-based

interfaces• Medidata, DataLabs, and Medrio systems• Oracle Inform interface based on FTP file

interactions

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Enterprise Resource Planning Interface

• SAP interface based on web services interface• Real time communication with inventory and

supply management systems• Automated kit list loading• Automated shipment requests

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Ease of Management• VL system is largely configurable• Studies can be created without custom

programming• Project Managers can add users, sites, and kits,

manage shipments, and change re-supply settings

• All screens are live reports and can be exported to CSV/Excel format

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Site Training• Face to face training at Investigator Meeting• Webinars: recorded for playback• Site Monitors: training at site initiation visit • Test System: available for user practice and

training until project is decommissioned• Users activated after training

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Helpdesk• VL can be first or second tier Helpdesk• Helpdesk staff can make most system changes

during a study-mostly fixing data entry errors

• Low rate of HelpDesk usage given system ease of use

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Startup Time• 1-2 weeks: Contract to User Specification Document• 1 week: User Specification to Test System

- VL and Customer can review test system (a system ‘walk-through’ meeting) during finalization of User Specification

• 2-3 weeks: Test System to Customer Testing-VL validation

• 1-2 weeks: Customer testing• 4 - 8 weeks Overall• Average: 4 weeks from User Spec. to Customer Testing

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Customization• Typically adds 2- 4 weeks• Complexity factors

- Dynamic randomization- Stratification- Visit schedule- Interfaces with 3rd party vendors

(for example, importing lab value for randomization qualification)

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System Validation• CORE system is validated

-No need to re-validate configurable elements for each study, speeding time to delivery

• Project-specific customizations to CORE system are always fully tested -Typically 2-3 week turnaround

• Customer performs User Acceptance Testing to ensure system meets study needs-Typically 3-5 days of testing-Highly dependent upon customer’s internal requirements

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Company Infrastructure• Redundant Data Centers

(Raleigh, NC and Atlanta, GA)• Transaction level redundancy• Robust QA, SDLC and validation procedures• Part 11 compliance• Well-documented change control system• First line and second line Helpdesk• Global toll free hotlines in 45 countries• Real time translation (if needed)

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Key Benefits• Simple intuitive interface • Ability to manage complex study regimens• Ease of use for site and administrative users• Speed of application • Configurable system• Fast startup (4-8 weeks)• Customization experience• Cost effective

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Key ContactMark Paul Managing PartnerCustomer Relationship ManagementVeracity Logic+1.919.225.7860mark@veracitylogic.com