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IBM, KPMG, Merck and Walmart to collaborate as part of FDA’s program to evaluate the use of blockchain to protect pharmaceutical product integrity
Jun 19, 2019, 14:28 PM by Michael CroftNEW YORK, NY, UNITED STATES - Jun 13, 2019 - IBM (NYSE:IBM), KPMG, Merck (NYSE:MRK), and Walmart (NYSE: WMT) today announced that the companies have been selected by the United States Food and Drug Administration (FDA) to be included in a program in support of the UFull story -
Shimmer and ClearSky Announce Partnership to Improve Analysis of Wearable Sensor Data for CNS Diseases
Jun 19, 2019, 08:17 AM by Michael CroftCAMBRIDGE, MA - Jun 19, 2019 - Shimmer Research, a global leader in wearable technology for research applications, and ClearSky Medical Diagnostics, a leader in analyzing wearable data for medical applications, today announced they are partnering to bring a new level of analytic capabilities to the use of wearable sensors in clinical researchFull story -
IDBS E-WorkBook chosen by Solvay for global R&I digital transformation
Jun 19, 2019, 05:43 AM by Michael CroftGUILDFORD, UNITED KINGDOM - Jun 19, 2019 - IDBS' E-WorkBook has been implemented by Solvay, an advanced materials and specialty chemicals company, as part of a digital transformation project that has removed paper-based processes across the organizationFull story -
Aircuity Announces Project with Net Zero Wilde Lake Middle School
Jun 18, 2019, 11:02 AM by Michael Croft, N/A - Jun 18, 2019 - NEWTON, Mass., USA - Aircuity (www.aircuity.com), creator of measurably better environments, announced the installation of its platform at Wilde Lake Middle School in Howard County, MarylandFull story -
Parexel Strengthens Risk-Based Monitoring Offering with CluePoints’ New Advanced Statistical Capabilities
Jun 18, 2019, 09:52 AM by Michael CroftWAYNE, 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 worlds 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 trialsFull 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 CroftFull storyBio-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.
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Deep Genomics Identifies Rare Disease Targets Using AI System
Jun 14, 2019, 13:25 PM by Michael CroftFull storyBio-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.
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Rho Facilitates Conversation on Change and Collaboration at DIA 2019
Jun 13, 2019, 19:41 PM by Michael CroftDURHAM, 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 FranciscoFull story -
OncoSec to Present Immunological Data at World Pharma Week 2019
Jun 13, 2019, 12:34 PM by Michael CroftSAN 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 GFull story -
Biobanking: A Thing Of The Past?
Jun 13, 2019, 09:15 AM by Michael CroftFull storyBio-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.
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Signant Health Appoints Lawrence Miller as Chief Technology Officer
Jun 13, 2019, 09:10 AM by Michael CroftPLYMOUTH 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 industrys most comprehensive patient-centric suite of technology solutions and servicesFull 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 CroftCAMBRIDGE, 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 programFull 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 CroftPRINCETON, 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 agencys abbreviated new drug application (ANDA) pathwayFull story -
Amsterdam University Medical Center wins MR Solutions’ newly launched Image of the Year Award
Jun 11, 2019, 12:52 PM by Michael CroftGUILDFORD, 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 imageFull story -
Quanticate Expands Presence in North America with New Toronto Office
Jun 11, 2019, 04:04 AM by Michael CroftTORONTO, 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 TorontoFull 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 CroftNEW 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)xFull story -
Golden Helix Releases Cancer Add-On To VSClinical
Jun 10, 2019, 11:35 AM by Michael CroftFull storyBio-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.
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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 CroftPRINCETON, 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 MeetingFull 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 CroftPHILADELPHIA, PA, UNITED STATES - Jun 10, 2019 - CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealthFull story -
Organoids And Their Impact On Pre-Clinical Drug Discovery
Jun 7, 2019, 12:40 PM by Michael CroftFull storyBio-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.