The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.
Bracket has released several new mobile applications to support Bring Your Own Device, a clinical trial technology which allows patients to report symptoms using a smartphone.
Certara’s new consulting firm will rely on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.
Medidata expects to become a strategic partner to even more pharma firms as Boehringer Ingelheim becomes the latest to transition to its cloud technology platform.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
Reliance on third-party software vendors differentiates INC Research from its technology-investing peers but will not be a disadvantage, according to a Jefferies analyst.
Trilantic Capital Partners Europe has bought a majority stake in Doppel Farmaceutici, citing the growth potential of Europe’s contracting market as the driver.
Sterigenics will triple gamma sterilisation capacity at a site in Arkansas on the back of strong demand from pharmaceutical and medical device customers.
Standard & Poor has assigned a ‘stable’ rating to Greatbatch after the contract manufacturer secured $1.5bn to buy fellow medical devicemaker Lake Region Medical.
A Japanese company has filed the first US FDA application for a drug with an embedded sensor which can tell doctors if patients have taken their pills.
Increasing pharma R&D spending is helping grow revenues for Medidata, which has boosted its cloud-based clinical technology through a partnership with Validic.
Companies that recommission old single-use devices would have the same liability as the original device maker under draft guidelines proposed by the MHRA.
Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.
Biocorp has raised €8.9m ($9.8m) through an IPO during what it called a period of “deep macroeconomic uncertainty” and has underlined plans to grow its drug delivery tech business internationally.
Minerals used to manufacture two of Charles River Laboratories’ products may be derived from questionable sources in Africa, though following a review of suppliers, the company has yet to fully understand where exactly they’re coming from, according to...
As biotech cash continues to flood the coffers of CROs (contract research organizations), large pharma R&D is still relatively flat, which means CROs will see about 6% growth annually, Brendan Brennan, CFO of Icon, told investors last week at the...
Adaptive clinical trial designs can be used in medical device studies as long as they are for “prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity,” the FDA says.
West Pharmaceutical Services expects annual revenues of up to $5m following the US FDA approval of a client’s product which uses West’s Crystal Zenith delivery system.
CRO Quintiles’ recent purchases of oncology and medical device specialist Novella and EHR service firm Encore Health Resources are starting to reap new benefits for the world’s largest CRO, the company reported in its earnings call on Wednesday.
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.
CRO Icon has launched a new medical device and diagnostics research group following the combination of recently acquired Aptiv Solutions’ expertise with its own experts.
US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.
As pipelines dwindle in a post-blockbuster world, pharma and biotech R&D operations are looking for new ways to take on non-traditional product development strategies that allow for less internal resources and increased efficiency while reducing costs,...
In another sign that mobile health technology is beginning to take off, cloud-based solution provider Medidata is collaborating with Garmin to integrate its vívofit activity tracker with the Medidata Clinical Cloud.
CRO consolidation continues with Rockville, MD-based Accelovance expanding its footprint into Europe with the acquisition of Cambridge, UK-based Altair Clinical.
Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.
Big pharma and CROs looking to exploit wearable technology in clinical trials will need to overcome reliability and regulatory problems, says an expert.
Quintiles subsidiary Novella Clinical and the academic research arm of the Cardiovascular Research Foundation (CRF) are collaborating to offer pre-clinical to post-market trial services to developers of cardiovascular drugs and devices.
Japan was involved in fewer drug industry-sponsored multi-regional clinical trials (MRCT) in 2014 than any year since 2008 according to the Pharmaceuticals and Medical Devices Agency (PDMA).