News

Today, PSI CRO, a full-service contract research organization, announced their expansion to India and the appointment of Dr. Radhika Bobba as Regional Director for India and the Asia-Pacific region.

New legislation for transparency - currently underway for clinical trial data, national drug pricing rules, and personal privacy - is clearly not enough to satisfy the transparency hawks in Europe.

Woodley Equipment Company, a leading specialist medical and laboratory equipment supplier to the Clinical Trials industry has welcomed a new member to their Team.

When we hear about a new blockbuster drug coming to market, we usually think about a medical treatment.

A recent NY Times piece by Tara Parker-Pope reported on the recommendation by a group at the National Cancer Institute to change both the definition of cancer as well as treatment and detection techniques.

CROs utilizing more bonuses to attract and retain talent

Acquisition will further increase the depth of Certara?s early drug development analysis, modeling and simulation expertise

The Association of Clinical Research Professionals (ACRP) and the Alliance for Clinical Research Excellence and Safety (ACRES) have joined forces to address critical challenges facing the clinical research enterprise globally and to improve medical product development and delivery worldwide.

Theorem Clinical Research has announced the addition of RadMD, a cutting-edge medical imaging expertise company, to its roster of strategic alliances.

Enables secure global document sharing and community management tools for life sciences

CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM techniques, that have been developed to improve data quality in studies, have been cited by the FDA in the recent release of the final guidance document detailing the agency's stance on the "Oversight of Clinical Investigations".

JAMA recently announced a change in editorial policy whereby it will no longer have independent academic statisticians review industry-sponsored clinical trial data.

New Service Enables Combination Tumor Assessments using both RECIST and irRC

I'm spending some time going through the Draft Guidance for Industry Oversight--A Risk-Based Approach to Monitoring, August 2011 vs. the Guidance for Industry--Oversight of Clinical Investigations--A Risk-Based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

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

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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.