This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subje...

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Annex 2 introduces important considerations for applying GCP to decentralized trials, pragmatic study designs, and real-world data.

Intelligent Bio Solutions (Nasdaq: INBS) has completed its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. All clinical data collection across the company’s 510(k) clinical program is now finished.The ICH GCP-compliant study ran over three weeks at three independent U.S. sites with 135 participants and nine operator users, reflecting typical workplace screening staff. Specimens will be verified via LC-MS/MS, and data analysis is underway as INBS targets submission in the second half of 2026.

This comprehensive 8-week certification program is designed to equip Investigators, Clinical Research Associates (CRAs), Contract Research

Intelligent Bio Solutions (Nasdaq: INBS) announced completion of a Usability Study for its Intelligent Fingerprinting Drug Screening System, supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. The study, run with CenExel Clinical Research, followed FDA guidance and ICH GCP standards and assessed how effectively non-specialist operators could be trained and could then use the system in a workplace environment.Fifteen operators without specialist laboratory knowledge or prior system experience participated, and according to Intelligent Bio Solutions, results confirm the system can be administered accurately by users with no specialist background. The Usability Study is part of a broader 510(k) program that also includes Cut-off, Method Comparison, Interference, precision, and penetration studies. The company states it remains on track to submit its 510(k) package in calendar H2 2026 as it targets entry into the U.S. drug screening market.

Intelligent Bio Solutions (Nasdaq: INBS) announced completion of its Interference Study for the Intelligent Fingerprinting Drug Screening System, a key component of its planned FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine.The study, conducted with CenExel Clinical Research under FDA guidance and ICH GCP standards, evaluated whether everyday substances such as hand creams, alcohol-based products, oils, dirt, and water impact test accuracy. Data analysis, including independent LC-MS/MS verification, is underway. The Interference Study forms part of a broader program including a clinical Cut-off Study, Method Comparison Study, precision testing, and penetration testing, aimed at addressing safety, accuracy, usability, specificity, and precision requirements. INBS expects to submit its 510(k) package in H2 2026, supporting its planned entry into the multi-billion-dollar U.S. drug screening market.

Clinical trial testing EBV mRNA vaccine alone and with immunotherapy for advanced Epstein-Barr virus-associated cancers in patients who failed standard treatments. Study evaluates safety and effective...

Health Canada is offering sponsors a no-fault inspection before the new ICH GCP guideline goes into effect, and the bid reveals how regulatory oversight is becoming something of a recruiting tool.

Ein ehrlicher Blick darauf, was es bedeutet, 2026 Google Cloud Ambassador — Infrastructure zu werden: die echten Kriterien, die Community-Arbeit und wie produktionsreife GCP-Erfahrung auf diesem Niveau wirklich aussieht.