Why Sponsors Choose Veracity Logic

Why Sponsors Choose VL

Veracity Logic, LLC Mark Paul, Managing Partner Phone: +1-919-225-7850 Email: [email protected]

Client Onboarding Project Oversight VL takes on old fashioned approach to on-boarding and startup. We assign an experienced project manager, we listen, plan, and execute, and develop a deep understanding of our customer’s needs. Our PMs remain on the study from startup to archive. We don’t switch out project managers when moving from development to operational phases. When we have to switch, we consult with our clients about a good fit. On average, our PMs have 20 years of experience in clinical trials so we can provide a deep level of understanding and experience to meet our customer’s needs.

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Project Start-Up Approach VL takes an unusual approach to IRT system review and startup. Because our system setup is largely configuration (not custom programming), VL can provide a proof-of-concept system and a customer walkthrough within a few days of agreement on the User Requirements. This approach gives our customers a live system to use and explore while we finalize the system specifications before we do final validation and user acceptance testing. This approach enables earlier and better customer understanding and feedback, early training, and prevents costly re-work.


Technology Build Accelerated Start-Up During the development of the User Requirements Specification (URS), VL project managers work with the customer to determine their needs and make suggestions based on our industry experience. VL then performs the configuration and validation of the system based on the study needs. For many study types, no custom programming is required. Our configuration tools greatly accelerate the startup time for a study. For more complex study types like adaptive or dynamic randomization, VL can provide customized solutions for studies when the standard VLIRT™ functionality does not adequately address a particular study need.


Training Train and Refresh VL provides real time online training and thorough user documentation. We have translated our documentation into multiple languages. VL maintains a ‘test version’ of IRT system throughout the study for user training and to refresh their knowledge on system functions. This system and our User Guides are made available to new team members.


Operational Experience Project Manager Assignment Our team averages over 20 years experience in IWR, IVR, randomization, supplies management, packaging, and working with a wide variety of vendors common to clinical development teams. As noted above, VL prefers to assign one project manager for all stages of a project to facilitate deep understanding of the study and the customer’s needs. We do not switch PMs between the development and operational phases as many vendors do. The PM provides on-going support of the study as well.


Helpdesk 24/7 Support VL maintains a 24/7/365 Helpdesk that is staffed by our PMs within our US offices. Users can expect responses quickly by a knowledgeable PM. The VL global Helpdesk system tracks every call and email that comes into the Helpdesk and assigns a tracking number for future reference. VL provides the operational team feedback from the Helpdesk information on common questions and issues. Because our IRT platform has been tested and improved continuously for the last eight years and because it is engineered for ease of use, VL has a long history of receiving very few ‘Help Calls’ from system users. VL recently expanded its Helpdesk services and staff in response to growing demand for VL services.


Customization Flexible and Configurable VL has been developing customer IRT solutions for the past eight years. Our flexible, configurable architecture provides a solid foundation for system extensions and customizations. VL has a history of taking useful customizations and making them part of our standard validated core system. Examples of recent customization include managing direct to patient shipping, real time interfaces with numerous EDC partners (for example, Medidata, Datalabs, and Medrio), generation of outbound reminder text messages and phone calls, and many examples of conditional visit schedules and complex dosing regimens.


Short Start-Up Timelines RapidStart Veracity’s technology and process can significantly shorten the typical study startup timeline for IRT. VL’s combination of configurable technology, RapidStart proof of concept review, and standardized templates for documentation enable a study startup in as little as two to four weeks. VL offers a hands-on approach to a customer in need of a quick startup. VL offers on-site collaboration, 24 hour turnaround on a proof of concept system, hands-on assistance with user testing and training, and a set of templates for quickly gathering and uploading site and user information required for startup. VL can assist with generation of subject randomization and container randomization lists required for randomized double blind studies.


Reduced Site Burden Real-Time Interface The VLIRT system makes like easier for your sites. VLIRT is engineered for ease of use and simplicity. VL leverages role-based functionality and data access at its core. The user interface is modified in real time to adjust to a user’s role, the functions they can perform, and the data they can view and/or edit. Only valid menu and pull down options appear. Data entry fields are dynamically generated in response to user role and user choices. he site can randomize a subject or record a visit within one minute after logging into the system (with a reasonable internet connection). VL recognizes and plans the user interface according to the critical path activities of randomizing and dose dispensation of the site coordinators and investigators.


Improved Supply Control Real-Time Status The VLIRT system enables better control of your supply chain with complete transparency of the location and status of all supplies in your study, from warehouse to study site and back. The real time nature of IRT provides an informed up-to-minute status of all your supplies. VLIRT offers both static and predictive resupply models to ensure your study achieves the correct balance of study availability at the site while minimized wastage and shipping costs.


Integration Real-Time Web Interfaces IRT has evolved over the past few years into a powerful study integration platform. VL leverages its technological skills in building and maintaining real time web-services interfaces with most major EDC, ePRO, and CTMS providers. VL has developed real-time interfaces with lab providers and distribution and packaging partners. VL has implemented integration routines with in-house and vendors system for distribution and control systems like SAP.


Reduced IRT Costs Templates Save Time and Fees VL can reduce the cost of using IRT on a study with several proprietary methods. The VLIRT system architecture is largely composed of a set of configurable and pre-validated modules. VL can quickly implement many types of study using our modular technology. We eliminate costly and time consuming custom programming for each study. Our study documentation templates provide clear direction on developing key documents and reduce the time and cost of maintaining required documentation. Our rapid proof of concept system development methodology and early system walkthrough provide rapid implementation. The customer gets a chance to use the system and see its features before final validation occurs, preventing costly and time wasting rework.


Returns and Accountability Site, Depot, Warehouse Awareness With increasing pressure on study drug management, VL has developed a full suite of modules for drug return and drug accountability. VL can implement returns processes at a kit level or at the contents or pill level. VLIRT can provide full transparency of the returns process from the site, depot, and warehouse level.


Temperature Management VLIRT has standard modules for tracking temperature deviations within a shipment, quarantining a shipment with suspected excursion, and tracking the status of all kits across all sites, depots, and warehouses.

Simplify, Simplify, Simplify “Efficient Technology” – just like our tagline says VL recognizes the burdens placed on site staff during a clinical study. For this reason, VL has worked for the last eight years to simplify and refine its IRT interface. Upon entering the system, the IRT data is automatically filtered to just the appropriate data. Menu options are modified specific to the user role. Major activities such as randomization or next visit dispensing are available on the main screen without additional clicks through a waterfall of menus. Major activities can be recorded in a matter of seconds not minutes. The site coordinator can select a subject, record a next visit and be given a kit number to dispense within four clicks of the mouse in the IWR platform. This information can be sent to a companion EDC system without user intervention via our web services interface technology.


Why Sponsors Choose VL

Veracity Logic, LLC Mark Paul, Managing Partner Phone: +1-919-225-7850 Email: [email protected]

Health & Medicine

Why Sponsors Choose Veracity Logic