• The Path To TMF Inspection-Readiness

    Clinical Research News | Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection.

    May 9, 2025

  • ALS Research Getting a Big Boost from Open Science Initiative

    Clinical Research News | A diagnosis of amyotrophic lateral sclerosis (ALS) is devastating news given to about 5,000 people in the U.S. each year. It is a rare central nervous system disease without a cure that relentlessly progresses, although death variably occurs anywhere from a few months to many years after symptoms first become noticeable.

    May 8, 2025

  • Joan Chambers on the Impact of Decentralized Clinical Trials

    Clinical Research News | At last month’s Bio-IT World Conference & Expo, Joan Chambers, Senior Consultant at Tufts Center for the Study of Drug Development (CDSS), spoke extensively about the future of clinical trials, particularly on the impact of decentralized clinical trials (DCTs), approaches that improve accessibility and convenience for the trial process, and insights on solutions for patient recruitment and retention.

    May 6, 2025

  • Mayo Clinic New Research, BioProcess360’s New Biotech Company, Flatiron Health, Massive Bio Partnership, More

    Clinical Research News | FYR announced a collaboration with Mayo Clinic seeking to advance the use of blood-based biomarkers in Parkinson’s disease research and clinical applications; BioProcess360 Partners announced the formation of ChromaGenix, a new biotechnology company focused on advancing downstream purification technologies for emerging biotherapeutics; Flatiron Health announced a strategic partnership with Massive Bio to expand patient identification capabilities and improve clinical trial enrollment across the US; and more.

    Apr 30, 2025

  • Follow the Money: AIRNA’s RNA Editor, Rare Disease Trial, More

    Clinical Research News | AIRNA will further develop its AIR-001 to address AATD by targeting and repairing the SERPINA1 mutation in the RNA transcript; Glycomine will advance its lead candidate, GLM101, into a Phase 2b clinical trial for a rare and life-threatening genetic disorder with no approved treatments; and more.

    Apr 29, 2025

  • Patient-Focused Clinical Trial Design Using Net Treatment Benefit

    Clinical Research News | Pharmaceutical companies and regulators are increasingly aligning around the need to better incorporate patient preferences into clinical trial design. This shift stems from a broader movement to measure whether treatments are efficacious on terms that are also valuable from the patient’s perspective.

    Apr 25, 2025