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CBER Unveils New Electronic Reporting System for Vaccine Adverse Events
| RAPS |  FDA's Center for Biologics Evaluation and Research has released an electronic submission system for companies to submit adverse events linked to vaccines. more

MolecularMatch Works to Commercialize Clinical-Trial-Matching Software
| Clinical Informatics News | MolecularMatch runs a free online search engine for clinical trials, with a registry that is beginning to rival clinicaltrials.gov. Now it wants to arm pathology labs with the same context-aware search engine to help interpret the results of molecular tests. more

Apple’s CareKit and the AI future of medical care
| Computerworld |  Apple's focus on personal health through connected devices ramps up a little more today with the release of the first four third party apps to integrate its newly announced open source CareKit technologies. more

Here Are Three Ways To Prevent Tragic Battles Between The FDA And Patients
| Forbes |  Last night, a panel of advisors to the Food and Drug Administration voted 7 to 3, with 3 abstentions, that the agency should not approve eteplirsen, a drug for a Duchenne muscular dystrophy, a rare, deadly, muscle-destroying disease, developed by Sarepta, a Cambridge, Mass.-based biotechnology firm. (On another vote, which [...] more

April Clinical News and Product Briefs
| Clinical Informatics News | The latest announcements and product releases from around the industry, including a major data sharing initiative for BRCA testing, and LifeMap Solutions' tailored service for smartphone-enabled research studies. more

Augmedix 'Rehumanizing’ Doctor Patient Relations Using Google Glass
| TechCrunch |  Augmedix, creator of a Google Glass platform for doctors to interact with medical data in real time, raised an additional $17 million this week. more

Sequencing Predicts Cancer Vaccine's Outcomes
| Clinical Informatics News | A new study by UCLA researchers demonstrates the use of next generation sequencing to predict survival of brain cancer patients treated with a cancer vaccine. The vaccine, an autologous dendritic cell therapy called DCVax-L, is under development by Northwest Biotherapeutics Inc., of Bethesda, Md., for glioblastoma multiforme (GBM). It is designed to activate the adaptive immune system, including T lymphocytes (T cells). more



Certara Launches New E-learning Platform for Biosimulation Education
| PRINCETON, NJ - Apr 28, 2016 - Certara®, the global biosimulation technology-enabled drug development company, today launched an e-learning platform through Certara University to satisfy the increased need for education in the burgeoning field of biosimulation or model-based drug development more

Oasmia Pharmaceutical Announces Positive Overall Survival Results from Phase III Study of Paclical/Apealea for Treatment of Ovarian Cancer
| NEW YORK, NY, UNITED STATES - Apr 27, 2016 - April 27, 2016 -- Oasmia Pharmaceutical AB (OASM), a developer of a new generation of drugs within human and veterinary oncology, today announced positive overall survival results for Paclical/Apealea in the Phase III study that included a total of 789 patients with epithelial ovarian cancer more

Montrium Releases eTMF Navigator to Provide Greater Business Intelligence in Clinical Trials
| MONTREAL, QC, CANADA - Apr 28, 2016 - Montrium, clinical trial technology specialists, and electronic content management software providers, today, announced the commercial release of the eTMF Navigator, an interactive intelligence dashboard integrated into eTMF Connect more

Queen’s University Belfast and Domainex Win Late-Stage Award to Progress Novel Lung Cancer Drug Candidate into the Clinic
| BELFAST AND CAMBRIDGE, UK - Apr 26, 2016 - Queen’s University Belfast and Domainex Ltd. announced today that they have secured a late-stage award from the Wellcome Trust Seeding Drug Discovery scheme to advance therapeutic candidate molecules into clinical evaluation for treatment of non-small cell lung carcinoma (NSCLC) more

Bracket Announces New Patient Engagement Tools for eCOA and RTSM Products
| WAYNE, PA, UNITED STATES - Apr 20, 2016 - A Bracket, a leading clinical trial specialty services provider, announced platform updates to Bracket eCOATM and Bracket RTSMTM to include native support for SMS messaging with patients and other stakeholders in clinical research programs more

Post-Authorization Study Develops Into Crucial Part of Drug Development Design
| BERLIN, GERMANY - Apr 20, 2016 - Post-authorization safety studies (PASS) are becoming an integral part of the medicines development. Planning the design of PASS in the early phases of a clinical trial will translate into significant time- and cost-efficiency of pre-approval research more

Rho to Highlight Clinical Trial Expertise, Recruit New Team Members During ACRP 2016 Global Conference
| CHAPEL HILL, NC - Apr 12, 2016 - Rho, a full-service contract research organization (CRO), is hiring a number of clinical research positions and will be looking to meet potential applicants in the field at the Association of Clinical Research Professionals (ACRP) during the group’s 2016 Global Conference, being held April 16-19 in Atlanta, Georgia more



 

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