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.
24-Jul-2014 - WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.
07-Jul-2014 - Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.
14-Apr-2014 - Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.
09-Apr-2014 - Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.
26-Mar-2014 - BioReliance has updated its big blue assay for the second time in six months by creating a version of the drug genotoxicity test that can be used in rats.
11-Mar-2014 - Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
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.