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Patient safety

Patient safety

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.

PPD’s Monitoring of Eliquis Trials ‘Adequate’ says US FDA

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.

Online Adverse Event Monitoring Could Guide Ph IV Spending say Researchers

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. 

Bioclinica Predicts Demand for TQT Trials in China

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.

UK ‘animal research’ labelling plan may have unintended consequences says Cyprotex

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. 

Rise of Russia as EMA Reports Global Stretch of Clinical Trials

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.

ICH Draft Guidance Aims to Help Stamp Out Drug Impurities

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.

CDSCO Moves to Speed UP Ethics and SAE Review Processes After Criticism

07-Mar-2013 - The CDSCO has started prescreening applications to register clinical trial ethics committees in a move designed to streamline the approval process.

New Guideline Lays Out Minimum Content of a Clinical Trial Protocol

15-Jan-2013 - Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols.

Public Citizen concerned about impact of 'lax' OHRP oversight on kids in trials

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.

Access to Medicines says outsourced clinical trials need to be codified

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.

News from PCT Europe

Post-approval service providers must collect less but more focussed data, says INC

28-Nov-2012 - Post-approval service providers must collect less but more focussed data for successful drug launches, according to INC Research.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

News from CPhI

India will stamp out "fly by night operators" in trial industry, says Gov

27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.

Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

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.


Strategic deals fit with regulators' risk-based site monitoring

08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.


PCT Europe 2012: Managing risk, emerging markets and industry criticism

08-Nov-2012 - 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.

Dispatches from AAPS

Bend Research hunting new partnerships to boost bioavailability offering

17-Oct-2012 - Bend Research is “actively” hunting new partnerships similar to its recent alliance with Dow.

Industry too afraid to include children in clinical trials, says expert

10-Oct-2012 - The pharma industry does not include children in clinical research for fear of mentally scarring them, according to

Quintiles set to boost Scotland's "promising" clinical trials market

02-Oct-2012 - Quintiles has forged a deal with the Scottish Government which it says will boost clinical trial activity in the country.

Children must be included in more trials to drive paediatric development: experts

01-Oct-2012 - Children are not included in enough clinical trials in the US, according to an FDA committee.

Quintiles makes trial management system more interactive

24-Sep-2012 - Quintiles says it has improved its trial management services with a new navigation platform for its Infosario programme.

Clinical trials should involve the elderly more, say experts

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.

Recruitment success in biosimilar trials relies on staff training: ISR

18-Sep-2012 - The key to improving patient recruitment in trials of biosimilar drugs is site staff training, according to ISR.

Online drug accountability systems will replace paper, says Cenduit

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.


New draft guidance on clinical trial insurance in the UK to accelerate ethics committees, says Government

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.

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