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Headlines > November 2012

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Sponsor oversight of CROs is lacking according to report; ACRO responds

29-Nov-2012 - Pharmaceutical sponsors are not doing enough to ensure the CROs they work with conduct trials safely and ethically, according to a new report.

SGS and blue inspection body to be excipact trained

29-Nov-2012 - The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

Selecta to discover food allergy drugs for Sanofi

28-Nov-2012 - Selecta Biosciences will provide Sanofi with discovery services in a deal that could be worth up to $900m.

No job cuts planned at SAFC post Sigma-Aldrich realignment, says president

28-Nov-2012 - No job cuts or facility divestitures are planned at SAFC under reorganisation announced by parent company Sigma-Aldrich.

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.

Merck Millipore wants to lead bioavailability solutions market

27-Nov-2012 - The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap with new lab.

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.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 - Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

People on the move: outsourcing jobs

26-Nov-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceutical outsourcing, including news from Onyx, Pacific Biomarker and Rx&D.

FDA stresses importance of IRB role in new draft guidelines

22-Nov-2012 - The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for...

News from CPhI

Single-use lets some Pharmas make own potent drugs but outsourcing demand still strong: Alkermes

22-Nov-2012 - Single-use technology will see more HP production brought in-house but contract manufacturers will still win-out, according to Alkermes.

News in brief

SAFC to be renamed under Sigma-Aldrich business rejig

22-Nov-2012 - Sigma-Aldrich has announced a plan to realign its business operations along regional and customer-focused lines.  

People on the move: jobs in pharma

22-Nov-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest career climbers including news from CTI, AndersonBrecon and CIS.

News from PCT

CRA turnover in China too high: PCT discussion

21-Nov-2012 - High CRA turnover in China often hinders trials, according to an Oxford University expert.

Poll results

CRO should stand for contract research organisation say readers

21-Nov-2012 - Outsourcing-pharma.com readers want the acronym CRO to stand for 'contract research organisation' according to the results of a snap poll we ran yesterday.

Catalent's Swindon cuts are result of decline in Zydis demand

21-Nov-2012 - Catalent will cut 45 staff from its Swindon facility after customers reduce Zydis order volumes.

QPS opens expanded Phase I unit in the Netherlands

21-Nov-2012 - CRO QPS has added another 24 beds to its Phase I site in the Netherlands, citing increasing demand for complex, early-phase research.

Poll

What’s in a name? Confusion, apparently

20-Nov-2012 - Outsourcing-pharma.com witnessed a fascinating debate on the definition of ‘CRO’ yesterday with terms like 'collaboration' and 'release' being suggested as potential alternatives.

Contract sales market on the rise thanks to wider range of services from CSOs

20-Nov-2012 - The contract sales market is set to hit $3.9bn in 2013, according to visiongain.

NMR culture anlaysis complies with ICH Q2A and B, says Spinnovation

20-Nov-2012 - CRO Spinnovation Biologics says its cell culture optimization technique complies with analytical methods detailed in ICH Q2A and Q2B guidelines.

Medpace boost EU device offering through Meditech takeover

20-Nov-2012 - Medpace has acquired Meditech Strategic Consulting in a bid to expand its European clinical trial services.

Sponsors waste millions collecting 'non-core' data says study

19-Nov-2012 - More analysis suggests that collecting data for non-core endpoints costs individual sponsors millions per clinical trial and the industry billions each year.

News from PCT Europe

CROs will swipe the "lion's share" of clinical development work: predicts PCT panel

19-Nov-2012 - CROs must swipe the lion’s share of clinical development work from Big Pharma for innovation to happen, according to a PCT panel.

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