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.
A new draft guidance stating the level of insurance cover required for trial participants in the UK will accelerate ethics committees’ approval process, according to experts.
Regulation of clinical trials in emerging markets is now too strict and is prompting sponsors and CROs to adopt “one-size-fits-all” designs, according to a new study.
Quanticate says it will eliminate unnecessarily “complicated spreadsheets” in clinical trial data analysis after integrating a new simplified web-based program into its own.
US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.
