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Found 248 articles

  • Gentronix recognised with King’s award after recor

    Gentronix recognised with King’s award after record international growth

    • 7 May 2024
    • Editor

    UK-based Contract Research Organisation (CRO) Gentronix – a leading specialist toxicology firm based at Alderley Park – has been awarded the King’s Award for Enterprise after achieving a triple-figure revenue growth following rapid expansion in international markets.

  • Boehringer Ingelheim shares positive results from

    Boehringer Ingelheim shares positive results from the first study worldwide in diabetic macular ischemia​

    • 7 May 2024
    • Editor

    Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI).

  • Merck Announces Positive Data for V116, an Investi

    Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

    • 30 Apr 2024
    • Editor

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Barcelona, Spain.

  • Bitterroot Bio Announces Dosing of First Participa

    Bitterroot Bio Announces Dosing of First Participants in a Phase 1, First-in-Human Study of BRB-002 in Healthy Volunteers

    • 30 Apr 2024
    • Editor

    Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, today announced that the first human participants have been dosed in a Phase 1 study of BRB-002 in healthy volunteers.

  • Rilzabrutinib LUNA 3 phase 3 study met primary end

    Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia

    • 23 Apr 2024
    • Editor

    Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP).

  • Emerging Trends in Clinical Data Management and Th

    Emerging Trends in Clinical Data Management and Their Impact on Hiring Needs

    • 22 Apr 2024
    • Lucy Walters

    In the rapidly evolving landscape of clinical trials, the role of data manager stands ever more critical at the confluence of innovation, technology, and regulatory compliance.

  • New 48-week frexalimab phase 2 data support potent

    New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

    • 17 Apr 2024
    • Editor

    Sanofi’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis.

  • What Does a Clinical SAS Programmer Do?

    What Does a Clinical SAS Programmer Do?

    • 16 Apr 2024
    • Lucy Walters

    Within the realm of clinical research, a Statistical Analysis System (SAS) Programmer is responsible for managing, analysing, and interpreting clinical data utilising SAS software. This includes developing and applying statistical techniques to assess the efficacy, safety, and value of a pharmaceutical product or medical procedure.

  • Roche’s Columvi meets primary endpoint of overall

    Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study

    • 16 Apr 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival.

  • A Recruiter’s Guide to Hiring a Biostatistician

    A Recruiter’s Guide to Hiring a Biostatistician

    • 11 Apr 2024
    • Lucy Walters

    In this recruiter guide, we explore the essential considerations for you to keep in mind when hiring a Biostatistician. From understanding the unique demands of the role to identifying key competencies and conducting effective interviews, this guide will help you to focus your candidate search and engage your target audience of talent.

  • The Evolution of Clinical Data Management

    The Evolution of Clinical Data Management

    • 10 Apr 2024
    • Lucy Walters

    Clinical Data Management (CDM) has drastically transformed over the years, proactively adapting to technological advancements, changing regulations, and the growing complexity of clinical trials.

  • Labcorp Announces Expansion of Precision Oncology

    Labcorp Announces Expansion of Precision Oncology Portfolio to Support Pharmaceutical, Biopharma, and Clinical Research in Advancing Drug Development Programs

    • 9 Apr 2024
    • Editor

    Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the strategic expansion of its precision oncology portfolio, solidifying its commitment to advancing cancer research and patient care on a global scale.

  • 9 Clinical Data Management Career Paths

    9 Clinical Data Management Career Paths

    • 8 Apr 2024
    • Lucy Walters

    As the life science industry becomes increasingly data-driven, the field of clinical data management (CDM) is expanding, offering a wealth of career opportunities for those interested in leveraging data to improve patient outcomes and healthcare processes.

  • Results announced from EMPACT-MI phase III trial i

    Results announced from EMPACT-MI phase III trial investigating the effect of Jardiance® (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack

    • 8 Apr 2024
    • Editor

    The EMPACT-MI phase III clinical trial showed a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure or all-cause mortality for empagliflozin versus placebo, which did not reach statistical significance.

  • A Recruiter’s Guide to Hiring a Clinical Data Mana

    A Recruiter’s Guide to Hiring a Clinical Data Manager

    • 5 Apr 2024
    • Lucy Walters

    From understanding the unique demands of the role to identifying key competencies and conducting effective interviews, this guide will provide you with valuable tips to help you focus your candidate search and engage top talent.

  • Parexel Named “Best Contract Research Organization

    Parexel Named “Best Contract Research Organization” at 17th Annual Vaccine Industry Excellence (ViE) Awards

    • 5 Apr 2024
    • Editor

    Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced it has been named “Best Contract Research Organization” at the 17th Annual Vaccine Industry Excellence (ViE) Awards.

  • Artificial Intelligence and Machine Learning in Cl

    Artificial Intelligence and Machine Learning in Clinical Data Management: Opportunities and Ethical Considerations

    • 4 Apr 2024
    • Lucy Walters

    Artificial Intelligence (AI) and Machine Learning (ML) promise to revolutionise how clinical data is collected, analysed, and utilised, offering unprecedented opportunities for enhancing trial efficiency and patient outcomes.

  • Phase 1/2 Interim Data on Moderna’s mRNA-3927, an

    Phase 1/2 Interim Data on Moderna’s mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia, Published in Nature

    • 4 Apr 2024
    • Editor

    Moderna, Inc. (NASDAQ:MRNA) today announced that interim data for a first-in-human, phase 1/2, open-label, dose optimization study and extension study, evaluating the safety and efficacy of mRNA-3927, an investigational mRNA therapy for propionic acidemia (PA), has been published in Nature.

  • REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug D

    REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients With Platinum-Resistant Ovarian Cancer

    • 4 Apr 2024
    • Editor

    Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 Phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer.

  • What Does a Clinical Research Coordinator (CRC) Do

    What Does a Clinical Research Coordinator (CRC) Do?

    • 3 Apr 2024
    • Lucy Walters

    A Clinical Research Coordinator (CRC) is a specialised research professional who works under the direction of a Clinical Principal Investigator (PI). They play an important role in conducting and managing clinical trials, providing outcomes that shape medical advances in areas such as preventative care, cures for diseases, and immunisations.