BUSINESS INSIGHTS, PHARMACY MARKET
prnewswire | April 21, 2023
ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere®, today announces the completion of its acquisition of Amplexor Life Sciences. This deal will deliver the most intelligent, connected, and comprehensive regulatory platform available, bringing increased efficiency for life sciences organizations as they bring new therapies to market.
A key development is the introduction of LifeSphere Quality Management, marking ArisGlobal's entry into the continuous quality improvement and risk management aspects of drug development.
LifeSphere Quality represents an expansion of ArisGlobal's interconnected drug development platform that spans the pharmaceutical product lifecycle including Clinical, Regulatory, Medical Affairs and Safety. Robust quality management system (QMS) capabilities, including automated workflows and analytics, are now available to support customers' global regulatory compliance needs.
The acquisition also rounds out the end-to-end LifeSphere Regulatory platform with the addition of a labeling management solution and accelerates the Regulatory product roadmap through the integration of enhanced global submission publishing capabilities.
ArisGlobal's intent to purchase was previously announced in late February 2023, and brings two new office locations in Croatia and Slovenia into ArisGlobal's geographic footprint.
About ArisGlobal
ArisGlobal is the creator of LifeSphere, a market leader in drug development technology solutions worldwide that is transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States.
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BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 03, 2023
ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems, and MEPHARMA, a strategic regulatory consulting services company, have partnered to provide a range of regulatory intelligence, compliance, and validation and automation solutions for companies in the United Arab Emirates (UAE) and the Middle East and North Africa (MENA).
MEPHARMA provides high-quality regulatory consulting services in addition to a host of other specialized services, including pharmacovigilance, GxP, due diligence and auditing for pharmaceutical, biotechnology and contract research organizations (CRO).
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world's leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.
Combining their extensive experience, MEPHARMA and ValGenesis are poised to expand next-generation digital validation and compliance solutions into countries in the MENA region.
"We are excited to partner with MEPHARMA and empower companies in this region with cutting-edge digital transformation tools that advance them on their Pharma 4.0 journey," says Bo Olsen, ValGenesis' SVP of Partners. "Together we provide well-defined, robust validation lifecycle management strategies and solutions that enable companies adhere to the most stringent global regulatory requirements."
"We are thrilled to collaborate with ValGenesis, the enterprise Validation Lifecycle Management Systems leader, to bring comprehensive regulatory intelligence, compliance, and validation solutions to local manufacturing companies in the UAE and MENA region," says Dr. Ayman Mahmoud, Managing Director at MEPHARMA. "Our partnership with ValGenesis will empower regional life sciences companies to streamline their validation processes and achieve maximum compliance with the highest GMP regional and global standards. Together, we are committed to delivering exceptional value to our clients and supporting their digital transformation journey towards Pharma 4.0."
ABOUT VALGENESIS
ValGenesis, Inc. is the creator of an innovative software platform that serves as 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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BUSINESS INSIGHTS, PHARMA TECH
prnewswire | April 11, 2023
Cerner Enviza, an Oracle company, along with John Snow Labs, are now helping support the U.S. Food and Drug Administration's drug safety Sentinel Initiative. By developing artificial intelligence (AI) tools aimed at extracting critical information from clinical notes within electronic health records (EHR), Oracle and John Snow will aid the FDA in better understanding the effects of medicines on large populations. Looking at the asthma drug, montelukast, and its possibility of mental health side effects, this two-year project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured data may help fill gaps in knowledge.
Cerner Enviza leverages decades of life sciences expertise spanning commercial, real world, clinical and regulatory research. This includes working with a broad range of Oracle provider networks to help accelerate the discovery, development, and deployment of health insights and therapies. John Snow Labs is known for its AI and NLP in healthcare and is the developer of the Spark NLP library. Together, Cerner Enviza and John Snow Labs will develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology.
Cerner Enviza, who will lead the team, was chosen by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute.
"Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center. We look forward to this new relationship and exciting initiative led by Cerner Enviza," said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center.
Traditional manual methods for analyzing clinician notes often can be a bottleneck for fully understanding the symptoms and outcomes that patients experience at the population level. However, advances in AI offer a scalable and transportable NLP processes.
"This is an incredible opportunity to work with these exceptional leaders to use Oracle's de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers," said Mike Kelly, global head, Cerner Enviza. "Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients."
"We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project," said David Talby, CTO, John Snow Labs. "We're honored by the Sentinel Innovation Center's vote of confidence in our joint ability to help investigate this use case. Together, Cerner Enviza and John Snow Labs have all the right expertise, data, and technology to make it happen."
The project known as the Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP) is also supported by the participation of Children's Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute who will provide clinical expertise and consulting.
About John Snow Labs
John Snow Labs is an AI and NLP company that provides software, models, and data to help healthcare and life science organizations put AI to good use. The company is the developer of Spark NLP and host of the NLP Summit.
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