Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
The Association of Clinical Research Organisations (ACRO) has welcomed new trial inspection guidance released by India’s Central Drugs Standard Control Organisation.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
Outsourcing-Pharma reviews the latest financial reports from the eClinical sector with news from Datatrak International, Medidata Solutions and Perceptive Informatics.
An academic clinical research centre that claims CROs markedly increase costs and reduce trial monitoring to box ticking, statements disputed by ACRO, has described its adoption of an in-house system.
Patient recruitment is boosted by health condition awareness strategies and financial incentives, according to research, but various methods of randomisation and consent design have no impact.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
Kendle recorded a 64 per cent drop in Q3 operating income and expects its strategic review of early stage, which will establish a fair value and consider all options, to be complete next quarter.
Synteract is to hire up to 30 additional staff by the end of 2011 to work at its recently expanded site in Research Triangle Park (RTP), North Carolina, US.
Cost cutting measures helped Parexel to one of its most profitable quarters after taking lower-than-expected revenues on project delays and cancellations.
BioClinica’s Optimiser software has bagged the firm a new five-year deal with a “top-ten” pharma company which intends to use the tool for all its clinical trial operations.
ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
PPD signs clinical imaging and formulation development collaborations, reorganises reporting units and cites “improved performance in emerging markets” and spending controls as key to third quarter gains.
PPD is collaborating with the Himalayan Institute and Hospital Trust (HIHT University) to form a large investigator site and expand its network of investigators in Northern India.
Indian CRAs need knowledge of ethics, clinical trial execution and general topics, such as the drug development process, according to a survey into training needs.
Icon reported a two per cent rise in Q3 net revenue, but saw profits dwindle in its central lab business after a growing backlog of work failed to convert to revenue as quickly as expected.
Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.
BioClinica is launching its new Trident IVR/IWR platform, to provide a cheaper, quicker way to set up, monitor and maintain randomisation and supplies in clinical trials.
ShangPharma has raised $87m through an IPO on the New York Stock Exchange according to a Bloomberg report, beating the $46m to $53m the Chinese CRO forecast.
A strategic partnership between New England IRB (NEIRB) and Veritas IRB of Montreal will see their clients following a common protocol review for studies they conduct throughout the US and Canada.
Easily translatable and adaptable simplified clinical research ethic training guidelines have been created to support field workers in low-resource settings.
Oracle Health Sciences has strengthened its clinical trial analytics offering to reduce start up times and offer greater insight into screening, recruitment and retention.
Wipro Technologies has introduced Rapid Trials to provide clients with a data collection platform that can be deployed quickly and with minimal infrastructure investment.
Mark Weinstein, CEO of Bioclinica, has hit back at a public letter from Nicusa Capital CEO, Paul Johnson, claiming that the company's corporate strategy is 'flawed' and demanding the resignation of three top executives.
Parexel opens its third office in Japan to address rising demands for clinical development and regulation services, and to supplement the capabilities of its Tokyo office which opened in 1997.
Belgium-based biopharmaceutical company, ThromboGenics, has signed a ten-year supply agreement with MSD Biologics, to produce microplasmin for the treatment of retinal disorders.
BioClinica shareholder Nicusa Capital is calling for the resignation of CEO Mark Weinstein, CFO Ted Kaminer and Chairman David Nowiki, after describing the firm’s corporate strategy as “defective.”
Covance has added a 40,000 sq ft biotech laboratory to its site in Indiana, US site to support its relationship with Eli Lilly and boost capacity outside Europe.
From 2005 to 2009 61 per cent of US NIH registered trials included at least one study site outside North America. Outsourcing-Pharma presents this, the 2009 downturn in US trials and other data as an interactive visualisation.
Advanced cardiovascular and metabolic services will be provided to biopharm by a strategic collaboration between CROs Cardialysis and Sticares InterACT.
Trials initiated in CEE and Russia fell 18 per cent year-on-year in 2009, ending a period of growth. Outsourcing-Pharma presents this rise and fall as an interactive visualisation.
