March 2017

Collaborative definition of patient centricity by AstraZeneca, patients and carers

Friday, March 31, 2017

AstraZeneca has announced that BMJ Innovations has published the first collaborative definition of patient centricity for the pharmaceutical industry. The definition was co-developed with patients and caregivers using research led by AstraZeneca and patient community advocates to ensure a deep understanding of patient needs and values. Ten associated patient-centric principles were also identified and published in BMJ Innovations to provide the pharmaceutical industry with a consistent reference point to sustain meaningful and mutually beneficial engagement with patients. Wider testing of these outputs among U.S. and European patient communities confirmed their validity.

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INC Research adds James Featherstone, Janet Baldwin, Nathalie Doize & Alastair MacDonald to team

Friday, March 31, 2017

INC Research Holdings, a global phase I to IV CRO, has appointed several new senior leaders to strengthen its Real World & Late Phase (RWLP) and Global Consulting offerings to biopharmaceutical customers worldwide. INC’s RWLP team is dedicated to real world, evidence-based data collection and works in close collaboration with the Company’s Global Consulting business to support customers at every stage of their product and portfolio development. INC’s expanded team will help maximize value for sponsors throughout the product lifecycle, from concept to commercialization, by providing consultative and operational expertise in the delivery of real-world evidence. The appointments reinforce INC’s continued focus on providing customers with strategic consulting services along with the right evidence to make the best clinical decisions in this rapidly expanding segment of the clinical research environment.

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KCR’s ethical assessment of clinical trials following EU CTR implementation

Thursday, March 30, 2017

Since the publication of the EU Clinical Trial Regulation (CTR) 536/2014 in the Official Journal, a new scheme of Clinical Trial Application (CTA) has been developed. Although certain rules for timelines, coordinated assessment and IT infrastructure are detailed, it remains up to each Member State how to organize ethical assessment and the cooperation of the Ethics Committee(s) (ECs) with National Competent Authorities (NCAs). KCR’s Anna Kubik, director Regulatory Affairs, who is a speaker at the DIA EuroMeeting this year, presented an overview of the current status focusing on the development of local requirements in terms of ethical assessment as well as proposed schemes respectively.

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Burst Biologics initiates multicenter study in spinal fusion

Wednesday, March 29, 2017

Burst Biologics has received IRB approval to begin a multicenter prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has shown very promising results in spinal fusion procedures. Fifteen clinical sites will participate throughout the U.S., with a total enrollment of 450 patients.

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