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  • Parexel Strengthens Risk-Based Monitoring Offering with CluePoints’ New Advanced Statistical Capabilities

    Jun 18, 2019, 09:52 AM by Michael Croft
    WAYNE, PA - Jun 18, 2019 - Parexel, a leading provider of Clinical, Consulting and Commercial solutions to accelerate the development of innovative new therapies to improve the world’s health, today announced  its strategic collaboration with CluePoints, an industry-leading provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, to enhance overall data quality oversight and ensure regulatory compliance within clinical trials
    Full story
  • High-Confidence Characterization Of Small Molecule 'Unknowns': How Software Is Enabling Intelligent, High-Resolution Accurate Mass LC-MS/MS Data Acquisition

    Jun 17, 2019, 07:35 AM by Michael Croft

    Bio-IT World Contributed Commentary | Liquid chromatography-tandem mass spectrometry has proven to be a powerful tool for small molecule analysis. However, the identification of so-called "unknown-unknowns" is extremely challenging.

    Full story
  • Deep Genomics Identifies Rare Disease Targets Using AI System

    Jun 14, 2019, 13:25 PM by Michael Croft

    Bio-IT World News Brief | Deep Genomics' AI system has identified 1,600 rare disease targets that can be drugged using its splice-switching oligonucleotide technology.

    Full story
  • Rho Facilitates Conversation on Change and Collaboration at DIA 2019

    Jun 13, 2019, 19:41 PM by Michael Croft
    DURHAM, NC - Jun 14, 2019 - Rho Facilitates Conversation on Change and Collaboration at DIA 2019Experts fromCRO to share best practices and lessons learned on Change Management andEffective Stakeholder Collaboration   WHAT:                 Rho, a full-service contract research organization (CRO), will highlight its clinical trial expertise during the Drug Information Association (DIA) Annual Meeting, being held June 23-27 in San Francisco
    Full story
  • OncoSec to Present Immunological Data at World Pharma Week 2019

    Jun 13, 2019, 12:34 PM by Michael Croft
    SAN DIEGO AND PENNINGTON, NJ - Jun 13, 2019 - OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing late-stage intratumoral cancer immunotherapies, today announced that Christopher G
    Full story
  • Biobanking: A Thing Of The Past?

    Jun 13, 2019, 09:15 AM by Michael Croft

    Bio-IT World | Andrew Brooks, COO at RUCDR Infinite Biologics and Professor of Genetics at Rutgers University, discusses the changes he's seen in biobanking over the last decade, including the rapid changes direct to consumer applications are bringing to research biobanks, and whether or not traditional biobanks are a thing of the past.

    Full story
  • Signant Health Appoints Lawrence Miller as Chief Technology Officer

    Jun 13, 2019, 09:10 AM by Michael Croft
    PLYMOUTH MEETING, PA - Jun 13, 2019 - Signant Health, formerly CRF Bracket, has appointed Lawrence Miller as Chief Technology Officer.  Signant unites electronic Clinical Outcomes Assessment (eCOA), eConsent, Patient Engagement, Interactive Response Technology (IRT), Clinical Supply Management and Endpoint Quality into the industry’s most comprehensive patient-centric suite of technology solutions and services
    Full story
  • X4 Pharmaceuticals and Invitae Announce Partnership to Provide No-Cost Genetic Testing to Patients Suspected of Primary Immunodeficiency Disease

    Jun 12, 2019, 13:49 PM by Michael Croft
    CAMBRIDGE, MA, UNITED STATES - Jun 12, 0019 -   X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, and Invitae Corporation (NYSE: NVTA), a leader in medical genetics, today announced a partnership to provide genetic testing at no cost to patients through its collaborative PATH4WARD program
    Full story
  • Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

    Jun 12, 2019, 08:18 AM by Michael Croft
    PRINCETON, NJ - Jun 12, 2019 - Certara® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp® physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway
    Full story
  • Amsterdam University Medical Center wins MR Solutions’ newly launched Image of the Year Award

    Jun 11, 2019, 12:52 PM by Michael Croft
    GUILDFORD, UNITED KINGDOM - Jun 11, 2019 - The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular research image
    Full story
  • Quanticate Expands Presence in North America with New Toronto Office

    Jun 11, 2019, 04:04 AM by Michael Croft
    TORONTO, ON, CANADA - Jun 11, 2019 - Quanticate, a leading global data-focused clinical research organisation (CRO), has announced plans to expand its presence in North America with the opening of a new office in Toronto
    Full story
  • Calliditas Therapeutics and Everest Medicines Enter into an Agreement to Develop and Commercialize Nefecon for IgA Nephropathy in Greater China and Singapore

    Jun 10, 2019, 13:13 PM by Michael Croft
    NEW YORK, NY, UNITED STATES - Jun 10, 2019 - Calliditas Therapeutics AB ("Calliditas") and Everest Medicines II Limited ("Everest Medicines") announced today that they have entered into a license agreement to develop and commercialize Calliditas' leading drug candidateNefeconin Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN)x
    Full story
  • Golden Helix Releases Cancer Add-On To VSClinical

    Jun 10, 2019, 11:35 AM by Michael Croft

    Bio-IT World News Brief | Golden Helix has announced a cancer addition to their clinical analytics product, VSClinical. This new capability will guide clinicians through the clinical assessment of somatic variants, adding workflows modeled off the guidelines issued by the Association of Molecular Pathologists.

    Full story
  • Certara Scientists to Highlight Model-informed Drug Development, PBPK, MBMA and Quantitative Systems Pharmacology Progress at PAGE 2019

    Jun 10, 2019, 10:23 AM by Michael Croft
    PRINCETON, NJ - Jun 10, 2019 - Certara® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its scientists will participate in 28 sessions at the Population Approach Group in Europe (PAGE) 2019 Annual Meeting
    Full story
  • Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research

    Jun 10, 2019, 09:56 AM by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Jun 10, 2019 - CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealth
    Full story
  • Organoids And Their Impact On Pre-Clinical Drug Discovery

    Jun 7, 2019, 12:40 PM by Michael Croft

    Bio-IT World | Pharmaceutical companies are looking for ways to save time and money in the drug discovery process. If there was a way to determine a therapy's impact in the pre-clinical process, researchers would have a better understanding of where to focus their efforts. This is where organoids come in.

    Full story
  • Aalto Bio Reagents Launches World's First Commercially Available Venezuela Equine Encephalitis Virus (VEEV) Protein

    Jun 7, 2019, 07:01 AM by Michael Croft
    DUBLIN, IRELAND - Jun 7, 2019 - On the occasion of the 11th International Global Virus Network meeting, Aalto Bio Reagents launches the first commercially available protein for the detection and diagnosis of Venezuela Equine Encephalitis NSP2 TC83
    Full story
  • Rho Experts Discuss the Importance of Early Patient Involvement in Clinical Trial Design in Free Webinar

    Jun 5, 2019, 13:54 PM by Michael Croft
    DURHAM, NC - Jun 6, 2019 - Rho Experts Discuss the Importance of Early Patient Involvement inClinical Trial Design in Free Webinar WHAT:                 Patient-centricity gets a lot of buzz as an essential aspect in research, drug development and disease management
    Full story
  • The Future Of Blockchain: The Use Cases Set To Reshape Life Sciences

    Jun 5, 2019, 07:50 AM by Michael Croft

    Bio-IT World Contributed Commentary | Ever since blockchain burst onto the scene a decade ago, people have continually found new—and sometimes odd—applications for the technology. Yet when it comes to the life sciences, a lack of practical applications has resulted in blockchain being considered a "hammer in search of a nail."

    Full story
  • BINDING SITE OFFERS TICK-BORNE ENCEPHALITIS (TBE) ANTIGENS FOR RESEARCH & IVD MANUFACTURING APPLICATIONS

    Jun 4, 2019, 11:01 AM by Michael Croft
    SAN DIEGO, CA - Jun 4, 2019 - ~~San Diego, CA . . . . BINDING SITE’s IMMUNOLOGICALS GROUP is pleased to announce the addition of two (2) new native Tick-Borne Encephalitis (TBE) viral antigens to its broad offering of products for in-vitro diagnostic (IVD) manufacturing and research applications
    Full story
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