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Hot Topics > Patient safety

Covance demolishes unfinished $175m lab in Virginia

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.

Big pharma demand for adaptive trials growing, says DaVita

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.

Theorem strengthens cardiovascular service with strategic alliance

07-Jan-2014 - Theorem has partnered with BioTelemetry in order to offer its clients cardiovascular testing services.

breaking news

EU MEPs plan to make drugmakers make trial data public

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.

Siemens wins Pfizer companion diagnostics deal

17-Dec-2013 - German electronics firm Siemens has been contracted to develop and commercialize companion diagnostics by US drug giant Pfizer.

Fewer animals used in drug R&D in 2011 says new EC report

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...

Italian CRO receives early phase accreditation in EUCROF pilot

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).

update

Boehringer Ingelheim looking for Bedford Labs buyer

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.

US FDA explains how compounders can register as outsourcing facilities

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 .

Dispatches from PCT

Pfizer: Active role for patients as smartphones lead way in virtual trials

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.

Simulation offers cheaper more objective monitoring of CRAs, firm says

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.

PCT - Day 2

Ultravox wrong: Vienna 'everything' to CROs this week

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.

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.

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