Veracity Logic Overview 2015 07-17

www.VeracityLogic.com Contact: David Goldston Based in Chapel Hill, NC Email: info@veracitylogic.com

Overview of Veracity Logic, LLC and

VLIRT® Features

Company History

•  Based in Research Triangle Park, NC, USA •  Incorporated and created 1st product in 2005 •  Deployed 1st project system in 2006 •  David Goldston, Computer System ValidaPon expert, joined company in 2008

•  Deployed 100th project system in 2014

•  Independent, management-‐owned, specialized provider of IRT systems for over 10 years

IRT Product Experience

•  VLIRT® CORE system used in over 100 clinical studies: – 20,000+ subjects – 3,500+ sites and 7,500+ users – 50+ countries and 45+ languages

•  MulPple therapeuPc areas •  Integrated web and voice capabiliPes •  Data IntegraPon with major EDC and ERP

Key VLIRT® Features

•  Subject Management – Screening and screen failure tracking – RandomizaPon (sta=c, stra=fied, dynamic, and adap=ve) – Drug assignment – DisconPnuaPon/early terminaPon – Cohort management – Dose level (PtraPon) management

Subject/PaPent Report The Subject/Patient Report captures all important data for each individual subject/patient including the Site ID, Patient ID, DOB, Initials, Randomization ID, Status within trial, Next Activity and corresponding Target Date.

Subject/PaPent “Rollup” Report

The Subject Rollup Report presents a chronological portrait of activities for each subject. It lists all important dates for each subject activity including screening, randomization, interim visits, and final activities such as completion or termination.

AcPviPes Report This Activities Report demonstrates the user’s ability to filter the report; in this case, the report has been filtered to show the all system activities for a single subject. Each screen contains relevant filtering and sorting options.

AcPviPes “Rollup” Report The Activities “Rollup” Report shows the real time enrollment status across all sites and all visit types. The report shows the data for each site and the total for all sites.

•  Clinical Trial Materials (CTM) Management –  StaPc, and PredicPve resupply models –  Automated and manual shipment requests –  Inventory tracking –  Temperature deviaPon/excursion tracking –  Individual and bulk kit management –  Drug accountability –  Expiry management –  Inventory reports – MulPple warehouse/depot configuraPons

CTM (e.g., Boeles) Report

This sample report was filtered to show all CTM assigned to subject 101001.

Inventory Report

This sample report was filtered to show counts of inventory located at site 101.

•  Diaries and electronic paPent-‐reported outcomes (ePRO) – Web and phone opPons – Flexible collecPon methods – Dynamic branching with single/mulPple choice quesPons

– Alerts and compliance reporPng

•  Outbound call/text/email capability

•  Standard funcPons: – Data IntegraPon with EDC, ERP, or Lab systems

•  Using real-‐Pme web services or batch interface

– Data on Demand: export any page to CSV file •  read with MS-‐Excel or other data analysis tools

– Context sensiPve menus – Full audit trail – Notes

ReporPng

•  VLIRT® is based on ‘Live Reports’ •  All screens (e.g., Subject, AcPvity, Site, etc.) are reports

•  All screens can be filtered •  Key reports include: –  Subject and acPvity reports –  Enrollment rollup report –  Shipment, CTM (e.g., Boeles), and inventory reports

•  All screens can be exported to CSV/Excel format

Electronic Data Capture Interface

•  Web services (real-‐Pme) XML-‐based interfaces •  Interfaces exist with mulPple EDC systems (e.g., Oracle, Medidata, Medrio, and OmniComm)

•  ExisPng templates for XML transacPons •  Bi-‐direcPonal transfers opPon •  Reduces redundancy and reconciliaPon costs

ERP Interface

•  SAP: VL has created web services (real-‐Pme) XML-‐based interface to SAP ERP System

•  Real-‐Pme communicaPons with inventory and supply management systems

•  Automated kit list loading •  Automated shipment requests

Easy to Manage

•  VLIRT® system is largely configurable – 80 – 90% of study acPviPes

•  Studies can be created without custom coding •  Clinical Project Managers can add sites and users, manage shipments, and update site resupply senngs

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

Site User Training

•  Face to face training at InvesPgator MeePng •  Train the trainer for CRAs •  Test / demo system available for training and user pracPce unPl project is decommissioned

•  Clinical Project Managers and CRAs can acPvate site users aoer training (when acPvaPng the clinical site)

Helpdesk

•  VL staff can act as first or second Per Helpdesk •  Historically we’ve averaged fewer than 1 help call per day across 20 acPve projects: –  IntuiPve user interface results in infrequent use of the Helpdesk aoer startup and training

– Ease of requesPng new password/passcode minimizes calls to Helpdesk (typically 85% of all help calls)

System Dashboard

•  System management feature •  Event logging •  Call logging •  Can view details of events or calls to assist with user support

•  Provides traceability for all system events

Startup Timeline

•  2 – 3 weeks, URS approval to UAT start – 1 – 2 weeks, Contract to User Requirements SpecificaPon (URS) approval

– 2 – 3 weeks, implementaPon and walk-‐through – 1 – 2 weeks, User Acceptance TesPng (UAT) – 1 business day, Release to ProducPon

CustomizaPon

•  Typically adds 2 – 4 weeks •  Complexity factors may include: –  Interfaces with 3rd party vendors

•  For example, imporPng lab values for randomizaPon qualificaPon

– Dynamic randomizaPon – Complex straPficaPon handling – Complex visit handling

ValidaPon

•  VLIRT® CORE system is validated – No need to re-‐validate configured elements for each study, reducing startup Pmeline

•  Project-‐specific customizaPons are fully tested •  Customer performs UAT to ensure system meets study needs –  Typically 1 – 2 weeks with 3 – 5 days of actual tesPng – Highly dependent on customer’s internal requirements

Company Infrastructure

•  Redundant Data Centers (Raleigh, NC and Atlanta, GA, USA)

•  TransacPon level redundancy •  Robust System Life Cycle, Disaster Recovery, and system validaPon procedures

•  21 CFR Part 11 compliance •  Documented change control procedures •  Toll-‐free hotlines in over 50 countries

Key Benefits

•  IntuiPve user interface •  Able to manage complex study regimens •  Ease of use for clinical sites, suppliers, and administraPve users

•  ApplicaPon speed •  Configurable system •  Fast startup (2 – 3 weeks URS to UAT) •  Cost effecPve

Partnering

•  Private (white label) branding •  PreferenPal pricing with referral incenPves •  Look and feel modificaPon via Cascading Style Sheets (CSS)

•  PM/Helpdesk access to system dashboard •  DemonstraPon/sales support •  One-‐day turnaround of RFPs

Request A Demo

Veracity Logic, LLC David Goldston, Managing Director Phone: +1-919-636-4780 Email: david@veracitylogic.com

Veracity Logic Overview 2015 07-17

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