Press Releases
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Wasdell Group granted HPRA licence at new EU headquarters
- Jan 24, 2019 - The Wasdell Group (Wasdell), a leading outsourcing partner for companies in the pharmaceutical and clinical trials industries, has been granted its Health Products Regulatory Authority (HPRA) licence for its new EU headquarters in Dundalk, Ireland
Jan 24, 2019
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IDDI starts Collaborative Research on Ground-Breaking Statistical Method for individualization of Therapy
, BELGIUM - Jan 23, 2019 - The treatment of patients in clinical practice relies on the results of randomized clinical trials. The statistical methods currently used to test the treatment effects in such trials take into account a single criterion called "primary endpoint"
Jan 23, 2019
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Niche Biometric CRO launches dedicated pharmacovigilance business
LONDON, UNITED KINGDOM - Jan 15, 2019 - LONDON (UK) - Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services
Jan 22, 2019
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ERT Achieves Milestone in Contributing to its Communities
PHILADELPHIA, PA, UNITED STATES - Jan 22, 2019 - ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it reached a new charitable contribution milestone in 2018
Jan 22, 2019
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PHARMASEAL Launches Engility CTMS, an Innovative Clinical Trial Management Platform for Unified Governance
NOTTINGHAM, UK - Jan 22, 2019 - PHARMASEAL, a new provider of clinical trial management and governance solutions to enter the market, has launched EngilityÔ CTMS, the first product to be released from its Engility B2B platform
Jan 22, 2019
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Integra Connect Announces Record Growth In 2018, With Nearly 1,100 Community Oncology Providers Now on Its IntegraCloud Platform
WEST PALM BEACH, FL - Jan 16, 2019 - Integra Connect, the leading provider of technologies and services for value-based specialty care, today announced that it nearly doubled the number of community oncology providers utilizing solutions connected by its IntegraCloud platform in 2018
Jan 16, 2019
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Lipotype announces “Lipidomics Excellence Award” for Breakthrough Lipidomics Projects
DRESDEN, GERMANY - Jan 16, 2019 - Call for Applications open till 30 March, 2019The international scientific community is called to submit applications for the premiere of the world's first award for cutting edge contributions to the progress of life sciences through lipidomics, the 2019 "Lipidomics Excellence Award" (LEA) until 30 March, 2019
Jan 16, 2019
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Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Fourth Consecutive Year
PRINCETON, NJ - Jan 15, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2018 were supported by Certara software or services
Jan 15, 2019
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PAREXEL Introduces New Dedicated Division to Help Emerging Biotech Companies Reach their Goals Quickly and Cost-Effectively
BOSTON, MA - Jan 7, 2019 - PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today introduced a new, dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively
Jan 7, 2019
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Certara Publishes New Report Investigating Success Factors for Outcomes-based Contracting, Giving Guidelines to Pharma and Payers
PRINCETON, NJ - Dec 19, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced a new research report that investigates the potential of pharmaceutical outcomes-based contracting
Dec 19, 2018
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Rho Announces New Regulatory Strategy and Submissions Business Segment
CHAPEL HILL, NC, UNITED STATES - Dec 10, 2018 - Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, today announced a new Regulatory Strategy and Submissions business segment
Dec 11, 2018
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FairJourney Biologics ‘Future-Proofs’ Therapeutic Antibody Discovery with Geneious Biologics
AUCKLAND CITY, NEW ZEALAND - Dec 10, 2018 - AUCKLAND, NZ – December 10, 2018 – Geneious Biologics, an enterprise software solution for companies engaged in screening of antibodies and antibody-like molecules, has been selected by FairJourney Biologics, a leading contract research organization (CRO), to support the companys growth as it incorporates increasingly large Sanger data sets and next-generation sequencing (NGS) into its discovery programs
Dec 10, 2018
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Rho Experts Explore Right-to-Try Legislation and Existing Expanded Access Programs in Free Webinar
CHAPEL HILL, NC - Dec 7, 2018 - Rho Experts Explore Right-to-Try Legislation and ExistingExpanded Access Programs in Free Webinar WHAT: The impact of Right-to-Try legislation has been in the news a lot recently, but what does the legislation mean for product sponsors? Rho, a full-service contract research organization (CRO), will explore both Right-to-Try legislation and existing Expanded Access Programs in a new free webinar, including:o Understanding sponsor responsibilities under these programs and when products may be eligibleo Evaluating options such as treatment protocols, treatment INDs, and emergency useo Discussing development risks associated with participation in these programs The webinar, "Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA's Expanded Access," will take place on Tuesday, Dec
Dec 7, 2018
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Industry Leaders Join Forces to Discuss Optimizing eConsent for Patient Centricity
PLYMOUTH MEETING, PA - Dec 6, 2018 - Clinical research and technology leaders from across the industry will share their data and expertise at an upcoming webinar hosted by CRF Health, a CRF Bracket company, to discuss how to improve patient centricity through electronic informed consent (eConsent)
Dec 6, 2018
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Certara Launches BaseCase Toolkits to Facilitate Pharmaceutical and Medical Device Field Teams’ HCP and Payer Presentations
PRINCETON, NJ - Dec 5, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced the launch of its BaseCase Toolkits, an add-on to BaseCase Interactive which helps pharmaceutical and medical device field representatives better manage and utilize their resources for use during customer presentations
Dec 5, 2018
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Cenduit LLC to Present Webinar Case Study on How to Help Biopharma Sponsors and CROs Navigate IRT System Change Requests (SCRs)
DURHAM, NC, UNITED STATES - Nov 27, 2018 - On Wednesday, December 12, Cenduit subject matter experts Andrew Rohrbaugh, Director of Client Delivery; and Chris Gent, Associate Director of Operational Excellence, will present a case study, in a free educational webinar on how sponsors and CROs can successfully steer through the rising tide of Protocol Amendments and System Change Requests (SCRs) utilizing a patient centric approach
Nov 30, 2018
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Greenphire Named to Deloitte's 2018 Technology Fast 500™ for Fifth Consecutive Year
KING OF PRUSSIA, PA, UNITED STATES - Nov 27, 2018 - Greenphire, the global leader in financial technology for clinical trials, announced today that it has been ranked as 391 on Deloitte's 2018 Technology Fast 500
Nov 29, 2018
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Certara Launches Trial Simulator 2.3 to Improve Clinical Trial Success
PRINCETON, NJ - Nov 28, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced the launch of version 2
Nov 28, 2018
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FDA Selects ArisGlobal Next-Generation Safety Platform to Implement New Integrated Safety Platform
MIAMI, FL, UNITED STATES - Nov 27, 2018 - The U.S. Food and Drug Administration (FDA) has selected Booz Allen Hamilton to support development, modernization, and enhancement of the FDA Adverse Event Reporting System (FAERS)
Nov 27, 2018
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The Pistoia Alliance Announces Major Milestone in Unified Data Model Project to Promote Life Sciences Collaboration
BOSTON, MA - Nov 27, 2018 - The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D, today announced the latest release of its Unified Data Model (UDM) file format, v5
Nov 26, 2018