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

    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.

    Jan 26, 2022

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

    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.

    Jan 25, 2022

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

    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).

    Jan 24, 2022

  • Where AI Can Add Efficiencies To Clinical Trials

    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.

    Jan 20, 2022

  • Trials@Home Exploring European Experience With Decentralized Model

    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.

    Jan 18, 2022

  • Parallelization Now Proven Approach in Clinical Trials

    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.

    Jan 14, 2022

  • 2022 Participant Engagement Award Finalists Announced

    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.

    Jan 13, 2022

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

    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.

    Jan 11, 2022

  • Bayer Pilots Platform Turning Surplus Clinical Trial Kits Into Donations

    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.

    Jan 11, 2022

  • Trendspotting: Decentralized Trials Maintain Momentum, Additional Remote Solutions, AI and Reducing Bias

    Clinical Research News | We spoke with clinical research leaders to gain insights into expectations for the coming year. They predicted direct-to-patient drug shipments, supply chain digitization, payviders, and AI with wearables and other clinical data, and more.

    Jan 10, 2022