News & Analysis on Clinical Trial Services & Contract Research And Development
Cambrex is investing $1m at its High Point, NC-based site, marking the most recent in a series of investments which will see the addition of 1,300 square feet and 15 new employees.
The owners of Synteract, Amulet Capital Partners, have acquired a global health communications and market access group with plans to merge it with Peloton Advantage, which it purchased earlier this year.
Guest column
M&A is a huge part of the CRO space. Inorganic growth has long been the go-to strategy for any CRO and we’re never surprised to see this month’s latest deal. However, I’d like to challenge the idea that this is always the best way to grow a CRO business.
Women have seen deficits and gains in their attempts to be included in clinical research, but as 2019 approaches equality seems forthcoming.
ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.
It’s been 25 years since the NIH Revitalization Act, yet, the industry is only now approaching parity in clinical research, says researcher.
The new year will bring more data than the last 500 decades, information that will be used to improve clinical trial design and shorten drug development timelines, say industry experts.
Pfizer’s sterile drug manufacturing site in Kansas received eight observations during an FDA inspection.
The industry has a “tremendous opportunity” to build on its progress by further improving operational performance in the face of pricing and patient access challenges.
Throughout 2018 the industry worked to listen more closely to the voice of the patient, though to secure this data, it must navigate currently misunderstood GDPR requirements in the new year.
Potentially increasing costs and dropping returns from investing in innovative medicines and devices will be among the main challenges faced in 2019, says industry analyst.
While several companies touted the potential of AI to disrupt the drug development industry in 2018, what practical applications can the industry expect next year?
NEWS IN BRIEF
The FDA provided Fresenius Kabi helped with a Drug Shortage Assistance Award for providing IV saline solution during the Puerto Rico hurricane crisis.
Access to medicines across the English Channel could be ‘significantly’ reduced for up to six months, if the UK leaves the EU without a deal, according to MP.