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Breaking News on Contract Research, Manufacturing & Clinical Trials

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US FDA to accept foreign trial data for approving medical devices

The FDA is releasing draft guidance articulating its current policy of accepting valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices. 

The US FDA will begin accepting foreign trial data for medical devices

CMOs earn €8.4m in EU grants to help scale-up manufacturing of thermo-stable vaccines

A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.

PPD pushes further into Asia with new Chinese central lab

CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there. 

INC joins with SCRS to create site advocacy group on investigator payments

Cash-strapped investigator sites seeking new ways to ensure they get paid promptly will find some new forms of relief in a recently formed Site Advocacy Group (SAG) created by INC Research and the Society for Clinical Research Sites (SCRS).

WCG calls on 1200 member institutions to adopt Accelerated Clinical Trial Agreement

As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage the 1,200 members of its research network to accept the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for...

HLS and Harlan create hairless mouse model

Huntingdon Life Sciences and Harlan Laboratories have launched a highly immunocompromised hairless mouse model for oncology and immunology research.

Spotlight

Outsourcing market’s recently IPO'd stock prices see early spike

Outsourcing market’s recently IPO'd stock prices see early spike

Between May 2013, when Quintiles went public , and this week, newly public companies’ stocks in the biopharma...

US FDA working to make clinical trials less wasteful

US FDA working to make clinical trials less wasteful

The US FDA is looking to set up master protocols that can continuously run and help cut...

Researchers enthusiastic over Obama’s new $215m precision medicine initiative

Researchers enthusiastic over Obama’s new $215m precision medicine initiative

In what was largely a pep rally for science, President Obama on Friday unveiled his $215m precision...

Strong USD to hit revenues but strategic CROs may see lower costs

Strong US Dollar to hit revenues but strategic CROs may see lower costs

The strengthening US Dollar will reduce CRO revenues, say analysts, but firms which have global strategic deals...

Quintiles, Parexel, PPD lead all CROs in US trial totals, review finds

Quintiles, Parexel, PPD lead all CROs in US trial totals, review finds

CROs (contract research organizations) continue to collaborate with sponsors on more clinical trials in the US, though...

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