The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.
The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.
Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.
Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.
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.
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.
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.
Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.
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.
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.
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 in December 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.
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.
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.
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 the European Commission last week.
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).
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.
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.
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.
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.
Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex.
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.
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.
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.
Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.
