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Search Results for "Workflow In Clinical Trial Company Approval"

07:21 EDT 23rd May 2013 | BioPortfolio

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Clinical Approvals - news, views, reports and blogs

Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and eff...

Clinical Trials Phase News

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will norma...

ATX-MS-1467 for patients with multiple sclerosis (MS)

ATX-MS-1467 is a novel treatment that was developed with the aim of working with the immune system to treat the underlying cause of disease rather than just treating the symptoms or suppressing the...

Abiraterone Acetate - Zytiga

On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...

Siemens

Siemens Healthcare is the second largest medical devices company in the world (based on annual sales), with sales of $17.4 billion. Specializing in the imaging, IT, diagnostics and workflow soluti...

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Proteonomix wins IRB approval for clinical trial of UMK-121

Proteonomix, a biotechnology company, has announced Institutional Review Board (IRB) approval for its clinical trial of UMK-121 in patients with end stage liver disease.

ACT’s Clinical Partner Receives FDA Approval to Initiate Clinical Trial Using the Company’s ...

UCLA’s Investigator IND Application for Embryonic Stem Cell-Based Clinical Trial to Evaluate Safety and Tolerability in Patients with Severe Myopia, or Nearsightedness, Approved by FDA

Ampio Pharmaceuticals receives FDA IND approval to start clinical trial of Ampion

Ampio Pharmaceuticals, Inc. today announced FDA acceptance of its IND and the treatment of the first fifteen (15) patients in its clinical trial using Ampion™ to treat osteoarthritis of the knee.

ERT introduces enhanced platform to streamline clinical trial data collection

Philadelphia-based ERT, a global provider of health outcomes services, has launched an enhanced clinical research workflow technology designed to streamline data collection, analysis and processing in...

Clinical trial of Echo Therapeutics' Symphony CGM System receives IRB approval

Echo Therapeutics, Inc., a company developing its needle-free Symphony CGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, announced today that the Company's clin...

Clinical trial design supports original accelerated approval of sunitinib for GIST

(American Association for Cancer Research) Patients benefitted from an important design element in the pivotal phase III clinical trial that led to Food and Drug Administration and worldwide regulator...

Neuralstem receives approval to begin ischemic stroke clinical trial in China

Neuralstem, Inc. has received approval to commence a clinical trial to treat motor deficits due to ischemic stroke with its spinal cord stem cells (NSI─566) at BaYi Brain Hospital, in Beijing, China...

BRIEF-Tissue Regenix's acute wounds trial approved

LONDON, April 16 (Reuters) - Tissue Regenix Group PLC : * Approval for start of clinical research trial * Approval given for start of clinical research trial to examine the effectiveness of Tissue Reg...

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Post-approval trials of new medicines: widening use or deepening knowledge? Analysis of 10 years of etanercept.

Objective: To investigate the main aims of the post-approval randomized controlled trials (RCTs) on etanercept and the extent to which they were designed to gain more comparative information. Methods:...

Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial.

A multicenter clinical trial conducted from 2005 to 2008 of a continuous flow left ventricular assist device (LVAD) resulted in Food and Drug Administration approval for bridge to transplantation. The...

Agile parallel bioinformatics workflow management using Pwrake.

ABSTRACT: BACKGROUND: In bioinformatics projects, scientific workflow systems are widely used to manage computational procedures. Full-featured workflow systems have been proposed to fulfil the demand...

Strategies for Personalized Medicine-Based Research and Implementation in the Clinical Workflow.

The decoding of the human genome, paralleled by the development of high-throughput technologies to obtain large-scale molecular data (e.g., information on genetic variations, transcription levels, and...

Could FDA Approval of Pre-exposure Prophylaxis Make a Difference? A Qualitative Study of PrEP Acceptability and FDA Perceptions Among Men Who Have Sex with Men.

The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 fo...

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