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I'm spending some time going through the Draft Guidance for Industry Oversight--A Risk-Based Approach to Monitoring, August 2011 vs. the Guidance for Industry--Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring, August 2013,

ICON plc, (NASDAQ: ICLR)a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and the National Clinical Trials and Research Centre (NCTRC) at theNational Taiwan University Hospital, today announced a collaboration agreement to enhance the set-up and management of clinical studies in Taiwan.

MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, and Heart Imaging Technologies (Heart IT), an industry leader in web-based medical image viewing and management solutions, are pleased to announce their strategic partnership and the integration of Heart IT?s WebPAX technology with MedNet?s eClinical solutions.

In July, at a meeting called by the U.S. Department of Health and Human Services on Human Research Protections, I reviewed the fascinating results of a randomized study that recently compared paper-based informed consent to electronic informed consent.

We?re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year?s near-record of 39 new molecular entities (NMEs) brought to market.

No matter how long you?ve been in the clinical trials business, the mantra is always the same: not enough investigators, not enough patients, enrollment falling behind, need for rescue sites, study budget overspend.

The clinical trial industry often believes that the costs of supplying drugs to clinical trials are a less significant contributor to the overall costs of running clinical trials.

Everyone is looking to rev up the biopharmaceutical development pipeline, and the FDA is working hard to do its part.

The implementation of best practices for clinical study and development conduct can streamline administrative burdens for investigator staff as well as study teams, and hopefully yield reduced costs in conducting global clinical development.

Simulator helps sponsors to assess arrhythmia risk before a candidate enters clinical trials; determine safe drug doses for specific patient populations.

Are clinical trial data shared sufficiently today?

Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring.

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Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring

Register now for the Risk-Based Monitoring Conference! October 24-25, 2013 | Philadelphia, Pennsylvania More on the Risk-Based Monitoring Conference

IMS Health

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Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring

Industry news focusing on the people and organizations who work in the clinical trials profession.

Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring.

Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring

Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry

Crown Bioscience, Inc., a leading global drug discovery and development service company, today announces that it has acquired the shares of Preclinical Oncology Services Limited (PRECOS), a leading pre-clinical research and development service provider with a specific focus on oncology.

Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry

Craig Wozniak, Head Americas Region, Clinical Operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring

A recent Twitter follower asked in regard to RBM technology, "Is there any experience w/regulators utilizing tool data as a roadmap to ID trouble sites during inspections?"

CRF Health, the leading electronic Clinical Outcome Assessment (eCOA) solutions provider announced several innovative enhancements to their TrialMax eCOA solutions.

Collaboration greatly reduces cost and administrative burden in clinical research.

Accessing and engaging patients is a very difficult task in today’s environment, as there is a bombardment of numerous media vehicles, including digital media, with varying intensities that penetrate patients’ senses, emotions, and thoughts.