Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.
18-Jul-2013 - A US FDA investigation of CRO PPD did not uncover any violations that might prompt a Form 483 for its work related to Bristol-Myers Squibb’s approved drug, Eliquis.
24-Jun-2013 - Researchers behind a new automated adverse drug event monitoring method say it could act as an early warning system and guide Phase IV trials.
18-Jun-2013 - Bioclinica has partnered with a Chinese hospital citing growing regulatory pressure for cardiac safety studies in the country as the key driver.
16-May-2013 - Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex.
15-Apr-2013 - An EMA report says increased Russian participation in European submitted clinical trials is part of a trend away from traditional regions, yet fluctuating legislation may affect numbers.
15-Apr-2013 - The US FDA has opened for public comment a new ICH draft guideline that aims to help manufacturers identify and control mutagenic impurities during the development of new drugs.
07-Mar-2013 - The CDSCO has started prescreening applications to register clinical trial ethics committees in a move designed to streamline the approval process.
15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.
10-Jan-2013 - A US advocacy group says poor HHS oversight of an ongoing type-1 diabetes study could undermine rules designed to protect children in trials.
03-Dec-2012 - The group whose comments on sponsor oversight drew criticism from ACRO says the industry group's preferred ‘trust and verify’ model only works if verification efforts are robust.
28-Nov-2012 - Post-approval service providers must collect less but more focussed data for successful drug launches, according to INC Research.
27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.
27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.
12-Nov-2012 - Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.
08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.
08-Nov-2012 - Outsourcing-Pharma.com is in Hamburg,Germany this week to meet the CROs, sponsors and academics gathered at PCT Europe to discuss the future of partnerships in clinical trials.
17-Oct-2012 - Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.
10-Oct-2012 - The pharma industry does not include children in clinical research for fear of mentally scarring them, according to ResearchNurses.co.
02-Oct-2012 - Quintiles has forged a deal with the Scottish Government which it says will boost clinical trial activity in the country.
01-Oct-2012 - Children are not included in enough clinical trials in the US, according to an FDA committee.
24-Sep-2012 - Quintiles says it has improved its trial management services with a new navigation platform for its Infosario programme.
19-Sep-2012 - Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.
18-Sep-2012 - The key to improving patient recruitment in trials of biosimilar drugs is site staff training, according to ISR.
04-Sep-2012 - Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.
02-Jul-2012 - A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.