Survey: Outsourcing R&D services pain points are numerous

Monday, September 18, 2017

More than 100 biotechnology and drug development leaders who responded to surveys conducted during industry conferences earlier this year reported a wide range of barriers to the outsourcing of research and development (R&D) services, including the contracts review process, intellectual property (IP) security concerns and service provider qualification. The surveys were conducted by Science Exchange, a secure platform for outsourced research and development (R&D), during the 2017 Biotechnology Innovation Organization (BIO) International Convention and 2017 Drug Industry Association (DIA) Global Annual Meeting. 

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Is eConsent adoption poised to grow?

Friday, September 1, 2017

Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

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The CenterWatch Monthly Industry Close-Up, July 2017

Saturday, July 1, 2017

Healthcare stakeholders recognize that there is a clear, ethical rationale to support patient engagement in clinical trials. Setting standards that describe how patient engagement is achieved will lead to research findings that are more pertinent to patients’ concerns and dilemmas.1 However, as there are limited comparative analytic studies to recommend a particular method that improves understanding of patients’ concerns1 and enables comparisons of the methods employed, it is unclear how to best engage patients and how to measure the success of engagement.

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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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Study: 65% of pharma and biotech invest in patient-centric initiatives

Wednesday, November 2, 2016

DIA, a professional community and knowledge exchange for global healthcare product development, announced results of its Study of Patient-Centric Initiatives in Drug Development, reporting that the majority of pharmaceutical and biotech companies surveys have adopted patient-centric initiatives in drug development.

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DIA forms educational partnership with Cardiac Safety Research Consortium

Monday, June 22, 2015

The Drug Information Association (DIA) announced an educational partnership with the Cardiac Safety Research Consortium (CSRC) called the Cardiac Safety Education Collaborative. The mission of the new collaborative is to improve the pharmaceutical, medical and academic communities’ understanding of cardiac safety, the leading cause of mar­keted drug recalls and drug development program terminations.

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