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.
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.
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.
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.
A lobby group has filed a complaint alleging illegal discrimination by airlines refusing to transport lab animals – a battle that will be difficult to win, says an industry expert.
The Asia-Pacific CRO Novotech has grown its operations in South Korea, a market that has seen greater interest from North American and European companies, says exec.
ABL named a successor to its previous CEO, Syneos has two new hires, and BTS Research appointed a VP to push its growth model. These, among other people on the move this month.
WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.
Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
As sponsors drive CROs to consolidate, building a firm the size of Iqvia would take more than 20 years organically, says consultant – who shares the stuff of nightmares (and dreams).
The predictive value of animal models is less than 50%, which makes them less informative than a coin flip, says AAPS speaker – who also argues that clinical trial participants are not fully aware of the risks.
