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Medidata: Prepare to embrace digital biomarkers in trials or lose competitiveness

The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.

Wearable tech, Big Data and Digital Biomarkers

AMRI re-opens troubled sterile injectable facility in New Mexico

AMRI’s Albuquerque, New Mexico sterile injectable facility has resumed full manufacturing operations following an environmental deviation. 

CROs mostly positive on proposed rule to make clinical trials more transparent

As part of a major transparency effort, the NIH (National Institutes of Health) and FDA are proposing to require the release of summary results of clinical trials for products that are unapproved or unlicensed.

More details on Cetero/PRACS implosion come to light

Lachman Consultants has revealed more of the story behind the decline of the now bankrupt CRO Cetero/PRACS, which even though it’s shuttered, is still dealing with the fallout from its data integrity issues.

German CMO looks to grow US biz through rise in SMEs and virtual pharma

Rottendorf is looking to break from being “the best kept secret in the CMO world” by targeting the thousands of virtual and SME pharma firms in the US, according to its CEO.

Spotlight

Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona

Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona

Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from...

In-house manufacturing ‘trounces’ outsourcing spend, report finds

In-house manufacturing investments ‘trounce’ outsourcing spend, report finds

Biopharma companies are not likely to outsource a larger chunk of their manufacturing than they have in...

Top 7 CROs soon to exceed 50% market share, Parexel CFO says

Top 7 CROs soon to exceed 50% market share, Parexel CFO says

As PRA Health Services goes public this week, nearly all of the top CROs are now public...

China sets new requirements for hospitals running clinical trials

China sets new requirements for hospitals running clinical trials

The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals...

INC stock launches up almost 10% as CEO says business as usual
Exclusive interview

INC stock launches up almost 10% as CEO says business as usual

The IPO boom for CROs is kicking off with INC Research’s stock offering, which as of Friday...