News

  1. PAREXEL Launches Perceptive MyTrials® Data-Driven Monitoring To Increase Patient Safety And Reduce Clinical Trial Costs 5/20/2014

    PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services organization, today announced the launch of its Perceptive MyTrials® Data-Driven Monitoring solution. Developed by PAREXEL Informatics, it is a key component of the Perceptive MyTrials eClinical platform, an integrated suite of applications for managing clinical trials.

    On-site monitoring is a critical aspect of trial management, with the primary function of identifying and mitigating patient safety or data quality risks at investigative sites. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have issued guidance to assist sponsors in developing risk-based monitoring strategies that enhance patient protection and improve trial data quality through more effective study oversight. They have encouraged greater use of centralized monitoring methods to evaluate clinical trial conduct and progress.

  2. Takeda And Lundbeck Present Results From Pivotal Phase 3 Clinical Trials With Vortioxetine, An Investigational Compound For Major Depressive Disorder 5/20/2013

    Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). These data will be presented at the 2013 American Psychiatric Association Annual Meeting (APA) in San Francisco.

  3. NanoPass Technologies Supports A CDC-Sponsored Phase 3 Study Of Polio Vaccine In Infants As Part Of its Global Health Initiative 5/13/2013

    NanoPass Technologies Ltd. ("NanoPass"), a pioneer in intradermal (into-the-skin or ID) vaccine delivery solutions, is collaborating with the US Center of Disease Control and prevention (CDC) in conducting a large phase 3 trial of polio vaccine in infants in South East Asia.

  4. Aptalis Selects Transperfect's Trial Interactive Technology As Its Pharmacovigilance System Master File (Psmf) Solution 4/22/2013

    TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.

  5. Savara Pharmaceuticals Initiates Phase 2 Clinical Trial Of AeroVanc For MRSA Lung Infection In Cystic Fibrosis Patients 4/18/2013

    Savara Pharmaceuticals announced today that the first patient has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis (CF) patients.

  6. Cellular Biomedicine Group Marks The Launch Of Clinical Trial For Knee Osteoarthritis (KOA) 4/3/2013

    This week Cellular Biomedicine Group (OTCQB: CBMG) held a ceremony to mark the launch of their clinical trial for haMPC (Human Adipose-derived Mesenchymal Progenitor Cells) therapy for Knee Osteoarthritis (KOA).

  7. Bioclinica, Inc. To Demonstrate Technology-Enhanced Capabilities At Upcoming Global Industry Events 4/2/2013

    BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.

  8. Telormedix Enrols First Patient For Phase II In Bladder Cancer 3/11/2013

    Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.

  9. MMS Set To Expand Disclosure Services With Registry Reporting Software TrialAssure 3/1/2013

    MMS Holdings Inc. recently announced that it has successfully executed disclosure management services for several clients and is poised to make strides in this area with its proprietary software, TrialAssure.

  10. Isis Pharmaceuticals Initiates Phase 2 Study Of ISIS-CRP Rx In Patients With Atrial Fibrillation 2/26/2013

     Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-CRPRx in patients with paroxysmal atrial fibrillation.