Kevin Burges Email & Phone Number

Radnor, Pennsylvania, Us

Leading the continued advancement of the ryze metadata repository platform and its integration into the wider Certara / Pinnacle 21 product suite.

Burlington, Ma, Us

Led the Product Management function at Formedix. Responsible for defining the near term goals and long term vision for Formedix products and their successful transition to a modern SAAS web platform, ryze. Worked with customers and industry experts to determine their needs and to deliver these needs within the ryze platform. Defined products, business-focused capabilities, user-focused requirements, customer journeys and user experience. Oversaw lightweight concept designs. Delivered an SDTM automation solution providing daily SDTM datasets from first patient in, used to expedite multiple Covid vaccine trials through rapid safety and efficacy insights.Member of a number of working groups and teams in the Clinical Data Interchange Standards Consortium (CDISC), including the XML Technology Governance Team which led the strategic development and data architecture of XML-based industry standards.

Burlington, Ma, Us

Established a robust Product function at Formedix. Major input in the evolution of the Development of the Professional Services functions. Continued building the IT function. Started the transformation of Formedix products from desktop applications to modern web applications, enabling their use anytime, anywhere.

Burlington, Ma, Us

Built and managed Development and Professional Services teams to deliver high quality CDISC-based products and services to streamline the pharmaceutical, medical device and biotechnology industries. Build and managed a robust IT infrastructure to support the growing organisation.Designed and managed the delivery of an enterprise software suite to streamline clinical trials through enabling the definition, standardisation, visualisation, maintenance and reuse of metadata describing those trials using industry standards.Designed, developed and managed the delivery of plugins allowing customers to work with several major 3rd party Electronic Data Capture (EDC) systems and implement custom workflows and data models.Defined and led Professional Services projects to bring the benefits of CDISC to organisations looking to embrace standards. Extensive business process analysis and re-engineering, creation and delivery of training, and proving the end-to-end benefits of standards-based metadata-driven clinical trials using our unique products. Close contact with customers to define and manage projects.

Burlington, Ma, Us

Conceived, architected, developed and brought to market:- the industry’s first CDISC Define-XML authoring tool, utilising Define-XML and SDTM to allow rapid generation of CDISC-compliant dataset specifications.- the industry’s first standards-based metadata-driven data transformation engine for clinical trials. - a unique plugin framework that allows integration with any 3rd party EDC system and any customer-specific workflow processes, enabling a “design once, run anywhere” capability unique in the industry.

Burlington, Ma, Us

Researched the clinical trials industry to understand its inefficiencies and how these could be overcome through technology.Conceived, architected, developed and brought to market:- the industry’s first CDISC ODM authoring tool allowing the definition, standardisation, visualisation, maintenance and reuse of clinical trial metadata in an industry standard format.- the industry’s first standards-based metadata-driven EDC system for clinical trials, supporting multiple sites, online/offline/concurrent data entry and remote monitoring.Pioneered the auto-generation of EDC databases from CDISC ODM specifications, dramatically reducing setup time while simultaneously increasing quality by removing human error.

Worked on developing a replacement for an old Hewlett Packard communications product for testing telephone networks. Designed and developed a compiler to migrate obscure binary network protocol definitions to a novel text-based structure developed in-house. This enabled reuse of existing protocol definitions and provided a way for users to learn how to use the new structure.

Armonk, New York, Ny, Us

Developed and tested a thin-client Network Computer. Analysed performance to determine optimal configuration. Administered the network.

Armonk, New York, Ny, Us

Developed and performed detailed structured tests for networking software including determining if faults were software-based or hardware-based. Set up and delivered customer demonstrations. Redesigned an ageing build process to remove manual steps and vastly decrease build time. Set up a video-conferencing facility.

Armonk, New York, Ny, Us

Developed hardware and software. Formed part of the hardware prototyping team, which built and tested cosmetic and functional models of new products. Set up customer demonstrations.

Beng Hons, Computer And Electronic Systems

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