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.
30-Jan-2014 - The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released...
23-Jan-2014 - The need to improve efficiency and comply with regulatory and geographical demands is driving the third-party clinical payment industry, say Greenphire, CFS and Clinverse.
22-Jan-2014 - Novo Nordisk has selected patient recruitment firm Trialbee to boost participant numbers in diabetes studies using its web-based platform.
16-Jan-2014 - As part of its shift to cut costs, Covance has demolished an unfinished $175m (€128m) toxicology laboratory it was building in Manassas, Virginia.
09-Jan-2014 - Davita Clinical Research (DCR) has said increasing client demand for adaptive trial designs in early Phase research prompted its partnership with Pacific Pharma Group study expert, Jon Ruckle.
07-Jan-2014 - Theorem has partnered with BioTelemetry in order to offer its clients cardiovascular testing services.
20-Dec-2013 - Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.
17-Dec-2013 - German electronics firm Siemens has been contracted to develop and commercialize companion diagnostics by US drug giant Pfizer.
16-Dec-2013 - Fewer animals were used to test the safety of life saving drugs in Europe in 2011 than in previous years according to the sixth edition of a research report by...
11-Dec-2013 - Italian CRO Centro Ricerche Cliniche di Verona (CRC) has become the first firm to be awarded a new early phase accreditation from the European CROs Federation (EUCROF).
05-Dec-2013 - CMO Ben Venue Laboratories has asked Bank of America Merrill Lynch to try and find a buyer for its generic injectables business, Bedford Labs.
02-Dec-2013 - The US FDA has defined compounding pharmacies as ‘outsourcing facilities’ in new guidance issued days after the Drug Quality and Security Act (DQSA) became law .
25-Nov-2013 - Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.
20-Nov-2013 - CRA Assessments says its standardised simulation approach to clinical trial monitors is a novel way for CROs and pharma firms to save costs and ensure quality.
19-Nov-2013 - CROs from across Europe and beyond have gathered in Vienna, Austria this week for Partnerships in Clinical Trials' (PCT) European congress. Outsourcing-pharma.com will be covering the show live.
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.