PHARMA TECH
PR Newswire | January 23, 2024
CGI, one of the largest business and IT consulting companies in the world, today announced a partnership with Körber aimed at enabling pharmaceutical and life sciences companies to improve their production processes by combining CGI's end-to-end services with Körber's Werum PAS-X Manufacturing Execution System (MES) Suite. The global partnership is designed to help clients increase efficiency, accuracy, and safety in pharma products and enhance decision-making through access to real-time data.
"CGI works side-by-side with clients to transform data into actionable insights to drive smart, sustainable and resilient operations," said Tim Hurlebaus President, U.S. Commercial & State Government operations and global executive sponsor for CGI's health and life sciences business. "This includes combining the benefits of MES and Industry 5.0 to gather rich insights to enable operational excellence. Our partnership with Körber complements our offerings portfolio, enabling us to deliver innovative new services and solutions to support the needs of our pharma and life sciences clients."
Körber's platform serves as a digital, real-time process controller to shorten time-to-market, lower production costs and enable a more patient-centric approach, improving outcomes and leading to improved health. Compliant with Good Manufacturing Practices, PAS-X MES presents a comprehensive view of data from diverse integrated systems, enabling faster and more informed decisions, which can be a critical advantage in an industry where timing and accuracy are paramount.
"Our PAS-X Products and Service Suites facilitate seamless digital transformation projects at our customers globally. By combining forces with CGI's global presence, expertise and complementary service portfolio in pharma and life sciences, we can offer a unique and compelling value proposition. CGI is one of the key partners to continue to expand our offering to our global customers" says Jan-Henrik Dieckert, COO Software, Körber Business Area Pharma.
Embedding robust IT and operational technology (OT) security, CGI's business consulting and MES services expertise enables faster, more seamless, and operationally integrated implementation of the platform, including transformation through technical integration, data migration, and organizational change management and adoption.
"In our global client insights research, pharma and life sciences executives said optimizing operations is their top business priority. CGI serves as a trusted advisor to help them achieve this priority through ROI-led digitization investments," said Maiken Lykke, Senior Vice-President, CGI Denmark. "We work collaboratively with clients to build solutions that tailor the right mix of services and technologies for their needs. We are pleased to partner with Körber to address the unique client challenges in this industry."
CGI delivers clinical and IT solutions for 11 of the top 20 global biotech and pharmaceutical companies, including helping these organizations optimize their processes; launch new therapies for cancer and rare diseases; and drive digital transformation across their research & development, manufacturing and commercial functions globally.
About CGI
Founded in 1976, CGI is among the largest independent IT and business consulting services firms in the world. With 91,500 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2023 reported revenue is C$14.30 billion.
About Körber
We are Körber – an international technology group with more than 12,000 employees at over 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, and Technologies, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.
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PHARMA TECH
PR Newswire | January 03, 2024
ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a leading Spanish pharmaceutical company selected ValGenesis VLMS – the industry's most trusted electronic validation lifecycle management system – to digitize its corporate validation process.
Founded in Spain over eight decades ago, the company focuses on developing over the counter (OTC) drugs and products. Since then, it has grown its production to include prescription (RX) drugs and launched its first generic product on the Spanish market.
The company's decision to transition from conventional paper-based methods signifies its move toward 100% digital operations, marking a new era in efficiency and traceability in manufacturing operations. The ValGenesis VLMS provides an all-encompassing digital solution to fully manage their validation lifecycle, ensuring accuracy, data integrity, and compliance with worldwide regulatory standards.
"We are pleased to onboard our first Spanish customer and first partner deal in the region," says Steve Reynolds, Chief Revenue Officer at ValGenesis. "This win represents a step-change in the way ValGenesis and its partners collaboratively address the industry's needs. We look forward to helping our customer leverage cutting-edge digital validation technology on their path to digital transformation, balancing speed with strict adherence to regulatory compliance."
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
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RESEARCH
PR Newswire | January 09, 2024
DotLab, a medical diagnostics company, announced top-tier pharmaceutical research clients for its DotEndo platform. The customers include global companies with interests in diagnosing or monitoring endometriosis on a Research Use Only basis in clinical trial subjects to support the development of new medicines.
"We're proud to share the news of our global pharmaceutical partners, which are complementary to our planned, large clinical offering for commercial endometriosis tests based on our technologies," said DotLab's founder, Heather Bowerman. "Our pharma partners conducted rigorous diligence of our science and intellectual property prior to the execution of our contracts, and they view our platform as the first of its kind and the leader in this space."
The DotEndo™ platform's AI/ML technology was developed via DotLab's EMPOWER clinical trial, a prospective, observational, multi-center study run at endometriosis centers of excellence across the United States. EMPOWER is the most robust clinical study of its type ever performed for diagnosing and monitoring endometriosis, making it an excellent foundation for the platform. Based on these successes, DotLab announced Morgan Stanley as a new investor in late 2023.
"We intend to continue to offer our pharma clients – and, ultimately, clinicians – a comprehensive endometriosis menu of tests and tools. Endometriosis is notorious for its complex biology, and there has long been a need for tests and tools to diagnose and monitor endometriosis – and ultimately, to improve endpoints for the disease in therapeutic trials," said Bowerman.
About DotLab
Dot Laboratories, Inc. ("DotLab") is solving some of the world's most significant diagnostic challenges via the latest advancements in multiomics and computational biology. The company delivers clinical innovations to areas of significant unmet need via novel, cutting-edge biomarkers and the power of machine learning to deliver non-invasive tests. The company has driven a paradigm shift in the identification and management of endometriosis. DotLab is female-founded and female-led.
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