Biotoxtech, South Korea To Deploy Comprehensive Suite of Preclinical Study Management and SEND Software Solutions from Instem

Instem Technology Selected to Streamline Preclinical Operations, Improve Productivity and Ensure SEND Compliance at South Korea’s Largest Preclinical R&D Facility

CONSHOHOCKEN, Pa.--(BUSINESS WIRE)-- Instem, a leading provider of IT solutions to the global life sciences market, announced today that South Korean Contract Research Organization (CRO), Biotoxtech Co., Ltd. (Biotoxtech) has purchased a comprehensive package of preclinical data collection, analysis and regulatory submissions management solutions to automate and optimize study related processes at its R&D facility in South Korea’s North Chungcheong Province.

Founded in August 2000, Biotoxtech boasts the largest R&D facility within South Korea and was the first CRO in the region to achieve GLP, AAALAC, Japan PMDA and US FDA certification. Biotoxtech performs around 800 experiments a year for its domestic and international clients; its extensive range of services includes Toxicology, Reproductive & Developmental, Ecotoxicological, Genetic Toxicology and Safety Pharmacology studies, as well as Pharmacokinetics testing and Biological Sample Analysis.

Biotoxtech sought to replace numerous disparate in-house and paper-based systems to harmonize preclinical data collection, management and reporting, streamline laboratory processes and meet growing client demand for SEND (Standard for Exchange of Nonclinical Data). Instem was selected following a comprehensive competitive vendor evaluation process that included detailed planning and discovery sessions, product demonstrations, portfolio review sessions and onsite visits to Instem offices in the UK and China.

This deal includes software and services from across Instem’s solution portfolio including Provantis®, the leading solution for preclinical study management, submit™, the most widely adopted software suite for creating, visualizing and managing SEND data, and Cyto Study Manager, for the management of genetic toxicology assays.

Key Facts

• Biotoxtech has purchased an extensive suite of Provantis modules including Inlife Toxicology, Pathology, Clinical Pathology, Dispense, Reproductive Toxicology, Report Assembly and Toxicology Resource Planning (TRP™)
• Biotoxtech to deploy Instem’s submit™ software solution for the creation and management of SEND compliant datasets
• Instem to assist Biotoxtech to reduce the amount of paper-based data used within their laboratory through the deployment of Instem’s Logbook technology
• Biotoxtech to harness the power of the Provantis Academy e-learning platform and a range of professional services, facilitating quick implementation and a rapid return on investment
• Biotoxtech has selected Cyto Study Manager to streamline their genetic toxicology study workflows into one comprehensive system. Cyto Study Manager will enable Biotoxtech to integrate genetox data acquisition, auditing, reporting, historical control data and study management into a single system, streamlining genetic toxicology operations, reducing costs, increasing efficiencies and improving regulatory compliance.

Dr. Jong-Koo Kang, CEO, Biotoxtech said “Our investment in Instem’s market leading solutions will deliver wide reaching, transformational benefits for our organization and our clients. We recognized that a deployment of this size will require a partner, not simply a vendor. Our combined commitment to this valuable project will vastly enrich our research processes and ensure even higher levels of service and faster response times for our clients.”

Jon Sparkes, Senior Director Sales, Europe & Asia, Instem, commented, “We are delighted to welcome Biotoxtech to our user community and are looking forward to delivering tangible business impact for them as their premier preclinical technology partner.”

About Biotoxtech

Established in August 2000, Biotoxtech Co., Ltd. (Biotoxtech) is a non-clinical Contract Research Organization based in Chungcheongbuk-do, South Korea.

Biotoxtech serves domestic and international clients and has submitted hundreds of documents to numerous international regulatory agencies including within the US, Japan and Europe for new compounds, as well as performing the most GLP certified non-clinical GLP studies in Korea.

Biotoxtech is the only CRO to be KOSDAQ listed in Korea and was the first organization in Asia to receive Full AAALAC Accreditation. Furthermore, Biotoxtech has received Korea’s first accreditations in safety pharmacology and alternatives to animal testing. In January 2015, Biotoxtech was the first domestic private non-clinical testing institution to receive GLP accreditation from the US FDA.

Biotoxtech established a joint venture company, SCAS-BTT Bioanalysis Co., Ltd. (SBB), with Japan’s Sumika Chemical Analysis Service to support the toxicokinetics/ pharmacokinetics sector.

For further information visit http://eng.biotoxtech.com/

About Instem

Instem is a global provider of leading software solutions and services that are helping over 500 clients bring their life enhancing products to market faster. We enable clients in the life sciences to more efficiently collect, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world.

Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making, leading to safer, more effective products.

Instem supports its global roster of clients through offices in the United States, United Kingdom, France, Japan, China and India.

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