Money can be saved throughout early-stage and Phase II trials by using the Collect, Ready, Hold service in preemption of a central review of imaging data, according to WorldCare Clinical.
Nose-diving net income in Q4 brought PharmaNet’s torrid year to an end, with the CRO hoping what may be its last financial release as a public company marks the start of its revival.
Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Contract research firm Icon Clinical saw its revenues advance by nearly 22 per cent in the last quarter of 2008, but still saw its share price slide as investors got the jitters over the firm’s cautious predictions for 2009.
Kendle International posted a 22 per cent drop in net income to $5m, after a computer error led to problems with a clinical trial carried out for one of its customers.
The issue of transparency in clinical research has raised its head again with a new study suggesting the results of Phase I trials are less likely to be published compared to other types of studies.
Patheon says the $183m (€142m) buy-out proposal by private equity group JLL Patheon Holdings is “opportunistic” and designed to take advantage of the recent stock-market related fluctuation in its valuation.
Study site operators want greater use of EDC technologies and more pharma industry investment to boost patient recruitment and reduce delays in clinical trials, according to an industry report due to be published next week.
Despite going through a difficult period PharmaNet is continuing to expand through the opening of another office in Latin America, which reinforces its commitment to the region.
WIL Research Laboratories has expanded into protein and small molecule bioanalysis and genetic toxicology through the acquisition of Midwest BioResearch.
Contract research organisation Bio-Imaging Technologies posted a 48 per cent hike on revenues in the fourth quarter of 2008, but still made a small net loss on the back of its CapMed division, which was sold last month.
AstraZeneca has installed a customised version of Cytel’s East clinical trial design software, which the pharma giant is using to increase the efficiency and security of its clinical trials.
US software specialist etrials Worldwide has added Belgian rival Unithink to an ongoing lawsuit that accuses two former executives, Robert Sammis and Brendon Ball, of breaching confidentiality agreements.
eClinical specialist Phase Forward saw revenues top guidance with a 28 per cent increase to $48m in the fourth quarter of 2008, driven by growth in its InForm electronic data capture (EDC) system.
Pfizer has preempted the Sunshine Act by promising to disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials.
PPD has reached an agreement to buy AbCRO, which it hopes will strengthen its position in the thriving Central and Eastern European (CEE) clinical trials scene.
MDS has formed a special committee to improve shareholder value following poor results and pressure from investors to sell some of its business units, which include a CRO division.
Russia approved 615 clinical trials last year, a 9 per cent increase over 2007, lending weight to the notion that the country is becoming a global hub for clinical testing.
US company PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in Southeast Asia in order to tap the fast-growing clinical research market in the region.
Parexel’s eClinical subsidiary Perceptive Informatics has entered into an alliance with AG Mednet to improve the efficiency and quality of the electronic image transfer process.
Contract research organisation PharmaNet Development Group has found a buyer just a few weeks after saying it was considering placing itself on the block.
A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
US contract development firm Azopharma has begun offering microdosing at its AvivoClin facility in Daytona Beach, Florida, joining market leaders like Xeleron and Covance in the Phase 0 trial sector.
The world’s largest contract research organisation, Covance, has maintained its earnings guidance for 2009 despite a slowdown in revenue growth and lower profits in the fourth quarter of 2008.
Icon has brought its operations in line with new FDA guidelines by implementing an electronic system to accelerate the adjudication of cardiovascular events in diabetes trials.
Contract research company Parexel saw its share rocket more than 30 per cent yesterday after it reported a hike in its second quarter revenues and despite a fallback in net profits.
The US National Institutes of Health has awarded a series of new contracts to try to stimulate greater use of sophisticated data management software in small to medium-sized clinical trials.
The US Food and Drug Administration (FDA) gave the go-ahead to the first clinical trials of a stem cell-based therapy late last week, in a major boost to the development of the technology.
Two US companies specialising in sleep disorders - Rem Medical and PsyPharma Global, have pooled their resources to offer research services to the pharmaceutical industry.
An Indian doctor has slammed the nation’s clinical trials, claiming they use the vulnerable, the system is corrupt and that the country lacks high quality scientists.
Senator Richard Moore has criticised transparency laws in Massachusetts, US, which he claims allow pharmaceutical companies to hide payments made to physicians conducting clinical trials.
Drug contract services specialist inVentive Health has selected a new office in Somerset, New Jersey, US which will house its patient outcomes, clinical, health and commercial division.
The rise in international, multi-centre clinical trials has complicated reporting pathways and led to institutional review boards (IRBs) being overloaded with adverse events, according to FDA guidance.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
Cincinatti, US-based clinical research organization Kendle has cut back its revenue expectations for 2008, primarily as a result of the strengthening of the US dollar, in common with some of its peers in the CRO sector.
Contract research organisation Bio-Imaging Technologies has decided to sell off its CapMed subsidiary in order to focus its efforts on its core business, providing imaging series to clinical investigators.
The proportion of global clinical trials conducted In India is expected to more than double between 2007 and 2012, according to market research firm RNCOS.
Perceptive Informatics has gained the right to use EQ-5D, which will allow the company to offer clinical study sponsors the option to collect health-related quality of life outcomes using a telephone.
Simple preclinical experiments should be able to predict whether immunotherapeutic medicines are safe to advance to preclinical testing in humans and avoid the Northwick Park trial that left six healthy volunteers hospitalised.
Canadian contract services company MDS Pharma Services reported disappointing results in its fiscal fourth quarter, with revenues dropping 9 per cent to $112m.
Contract research organisation PharmaNet Development Group is considering a sale of the business as it tries to recover from a difficult year marked by shrinking revenues and cancelled contracts.
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