• The Emerging Role Of Pharmacists In Clinical Research

    Jan 27 | Clinical Research News | The role pharmacists play in the community is the same one they should be playing in clinical research, according to Gerald Finken, founder and CEO of RxE2 whose mission it is to help make that happen. His belief is that “community-based clinical trials” in general can be better for patient care, the pharmacy as a profession, and study sponsors who have long had trouble recruiting enough patients into their studies. More

  • Looking Forward to EU Regulation (EU) No 536/2014

    Jan 26 | Clinical Research News | The EU Clinical Trials Register will be implemented on 31 January 2022, with the launch of the harmonized Clinical Trials Information System (CTIS) in all EU and EEA Member States. It is one of the most fundamental changes in the regulatory landscape for clinical trials in Europe. It is both historic and exciting. More

  • Canadian Brain Institute Opens Data Sharing on Alzheimer’s, Parkinson’s, More

    Jan 25 | Clinical Research News | After a decade of methodical preparation, Canada’s Ontario Brain Institute's (OBI) neuroinformatics platform, Brain-CODE, launched its open data sharing feature for global brain disorder research. More

  • Logistical Challenges Of The ‘Reverse Supply Chain’ For Biospecimens

    Jan 24 | Clinical Research News | The pandemic has served to highlight shortcomings of traditional practices around the cold-chain transport of biospecimens for clinical trials—including no backup plans when airports, borders, and study sites unexpectedly close. Even in normal times, default choices such as contracting mostly if not exclusively with premium couriers, can “artificially increase the cost of clinical trial conduct,” in the view of Thomas McDonald, associate director of biospecimen logistics for Bristol Myers Squibb Co. (BMS). More

  • Where AI Can Add Efficiencies To Clinical Trials

    Jan 20 | Clinical Research News | Acceptance of artificial intelligence (AI) in clinical research is on the rise thanks, in part, to its pairing with human expert oversight. The result is faster, more efficient clinical trials with less of the bias associated with purely manual evaluations while sidestepping the potential risks of AI. More

  • Trials@Home Exploring European Experience With Decentralized Model

    Jan 18 | Clinical Research News | Next year, a pan-European pilot study gets underway comparing the performance of hybrid and fully decentralized clinical trial models with conventional brick-and-mortar settings where the endpoints are operational metrics such as recruitment speed and diversity of enrolled populations. The focus of the study—the cornerstone of the broader Trials@Home project—is to see what decentralized approaches are possible across a continent with a mix of different languages, regulatory authorities, and privacy laws. More

  • Parallelization Now Proven Approach in Clinical Trials

    Jan 14 | Clinical Research News | Technology will continue to play a large role in how we conduct trials, but new ways of working will have to be implemented to truly drive change. During the COVID-19 vaccine trials, several new approaches emerged that helped speed the trials and bring the vaccines to market in record time. One such approach is fast-tracking, or parallelization. More

  • 2022 Participant Engagement Award Finalists Announced

    Jan 13 | Clinical Research News | Finalists have been named for the sixth annual Participant Engagement Award. Their work will be highlighted, and a winner will be named at the upcoming 2022 Summit for Clinical Ops Executives (SCOPE), February 7-10 in Orlando, Fla. More

  • Seqster, National Pancreas Foundation, Launch Pancreatic Disease Patient Registry

    Jan 11 | Clinical Research News | Seqster announced today a multi-year partnership with The National Pancreas Foundation, a nonprofit organization that provides hope for those suffering from pancreatitis and pancreatic cancer, to create the country’s largest, most inclusive pancreatic disease patient registry. The registry uses Seqster technology to connect to any EHR, genomic DNA test, and wearable/remote monitoring device, providing patients with a complete longitudinal health record in real-time. More

  • Bayer Pilots Platform Turning Surplus Clinical Trial Kits Into Donations

    Jan 11 | Clinical Research News | The scalable, not-for-profit technology platform Kits4Life is helping the clinical trial community divert unused and excess study supplies to healthcare organizations around the world that are qualified to accept humanitarian aid. In doing so, the cross-sector initiative has turned the “meaningless act” of destroying the surplus into an impactful gesture of corporate social responsibility and sustainability. More
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