Mar 23, 2020, 15:27 by

Rho, a full-service contract research organization (CRO) that helps pharmaceutical and biotechnology companies bring their products to market through high-quality clinical research services, will outline and provide tips on the U.S. Food and Drug Administration (FDA)’s new sponsor responsibilities for managing risks in clinical trials in an upcoming webinar, “Managing the Risks of Implementing E6R2.” The webinar will take place on Wednesday, March 25, from 1-2 p.m. EST.

Mar 23, 2020, 09:41 by User Not Found

Clinical Research News | A growing body of evidence suggests there are multiple health benefits to working with, rather than against, the body’s natural circadian rhythms—starting with when we eat, sleep, and take our medicines. Basic science research and observational studies have long dominated the literature, but more interventional trials are now getting underway aimed at correcting disturbances in biological timing triggered by disease, advancing age, and always-on modern lifestyles, as well as optimizing outcomes based on treatment timing.

Mar 18, 2020, 09:16 by

Coronavirus could be detected using Iceni Diagnostics’ rapid, point-of-care screening technology, and distinguish between different viral strains

Mar 18, 2020, 09:14 by User Not Found

Clinical Research News Contributed Commentary | New methods for collecting, analyzing, and sharing clinical trial data are needed in the era of personalized medicine. Beginning this year, we’ll see new trial designs being introduced that recognize a larger, broader section of the patient population.

Mar 12, 2020, 13:06 by

MR Solutions has installed a 3T PET-MR preclinical imaging system at Western University’s one of a kind ImPaKT Laboratory in Ontario.

Mar 12, 2020, 08:17 by User Not Found

Clinical Research News | How to assess the quality of real-world data (RWD) for research purposes and apply it in real-world scenarios to add efficiencies to clinical trials and support claims about drug product effectiveness were top topics of interest at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando. Many providers in the fast-growing RWD landscape are focused on a specific therapeutic area, including Flatiron Health. In addition to offering an oncology-specific electronic health record (EHR), the company has partnered with the U.S. Food and Drug Administration (FDA) to find ways to integrate EHR-derived evidence into regulatory decision-making.

Mar 11, 2020, 08:54 by User Not Found

Clinical Research News | Novel digital endpoints, including motion-detecting sensors and electronic patient-reported outcomes, hold tremendous promise for advancing precision medicine, expanding the reach of clinical research and reducing the burden of study participation. But adoption is being slowed by the abundance of tools and measures, sponsor inexperience with the technologies, and unfamiliar risks that software introduces into trials.

Mar 10, 2020, 13:38 by

Coronavirus News: Longhorn’s PrimeStore MTM is the Only FDA Cleared Nucleic Transport Device that Inactivates Microbes Within the Device Allowing for Safe Transport and Testing

Mar 10, 2020, 09:12 by User Not Found

Clinical Research News | Agencies around the world hold highly consistent views on the use of real-world data (RWD) to support regulatory decision-making—especially when it comes to synthetic control arms in rare disease studies. The barriers have less to do with regulators than data access, quality, and completeness and the technical skills required to harmonize, link and enrich disparate datasets, based on a pair of case study presentations made at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

Mar 9, 2020, 12:46 by User Not Found

Clinical Research News | Pfizer has teamed up with digital training company Gronstedt Group to bring virtual reality (VR) simulations to investigative sites as a way of improving compliance with clinical trial protocols, including the way study drugs get compounded. The VR solution was demonstrated live during a recent co-presentation at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

Mar 9, 2020, 12:38 by

WIRB-Copernicus IRB will give priority to the institutional review board (IRB) review of potentially life-saving COVID-19 vaccines and medications and waive their initial protocol review fees. 

Mar 6, 2020, 09:38 by User Not Found

Clinical Research News | ORLANDO—“We’re really heading toward a pathway that’s unsustainable for clinical development,” said Jacob LaPorte, co-founder, VP, and Global Head of BIOME—Novartis’ Digital Innovation Lab. “You look at ROI for R&D and every year it drops, and I think there some real macro-picture issues that are challenging. Solving this problem around clinical development is one of the biggest grand challenges for R&D now.”

Mar 5, 2020, 09:39 by User Not Found

Clinical Research News | A surge in innovative pharmaceutical drug discovery has coincided with a decline in a return on investment (ROI) in pharmaceutical R&D. But, according to a new research report, a remedy is readily available.

Mar 4, 2020, 15:41 by

First taxonomy branch focuses on acupuncture, and will open up new resources to modern biomedical sciences as global interest in Traditional Chinese Medicine grows

Mar 4, 2020, 10:05 by

Mar 4, 2020, 09:51 by User Not Found

Clinical Research News | The medical and pharma industries, not the patients, are the cause of low clinical trial participation, says one patient advocate. The remedy is available but requires these industries to forego rigid paradigms, to re-examine their thinking on patient participation, and to refocus their priorities.

Mar 3, 2020, 10:41 by

Mar 3, 2020, 10:41 by

Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, announced today that it is developing several new products that could help advance precision medicine research by expanding the capabilities and applications of its CELLSEARCH and DEPArray technologies, for rare cells isolation and single cell analysis.

Mar 3, 2020, 10:41 by

Please find attached a press release on our big win at the North West Coast Research and Innovation Awards.

Mar 3, 2020, 10:40 by

Ubiquitome has developed Liberty 16, a mobile app connected device that can test for COVID-19 within 40 minutes at the factory, school or anywhere.