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Clinical Trial Design Articles & Analysis
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Together, SOPHiA GENETICS and Boundless Bio pioneered the ecDNA Solution (ECS) algorithm to detect the presence of ecDNA using routine clinical next-generation sequencing (NGS) data. ECS is the first ecDNA clinical trial assay and was designed by SOPHiA GENETICS in alignment with FDA guidelines as an Investigational Use Only ...
The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims ...
ByBayer AG
Based on these data, a first-in-human trial with BAY 2965501 in patients with advanced solid tumors was initiated and is currently enrolling patients. ...
ByBayer AG
Biolojic uses its proprietary AI platform to design antibodies with new capabilities to cure disease, ushering in a new era of smart therapeutics Biolojic Tel Aviv to focus on computational design of antibodies; Boston location will focus on drug development Biolojic Design, a unique technology company pioneering computational ...
Airfinity announces today the launch of Airfinity IDA (Infectious Disease Analytics) 360, a new platform that will provide a comprehensive overview of vaccine and therapeutics candidates across the full infectious disease landscape. Airfinity IDA 360, a first-of-its-kind product in the health analytics market, will be a centralised source of competitive intelligence, providing clear and near ...
About the webinar 2020/21 led to significant clinical trial innovation in clinical trials in response to the Covid-19 pandemic with 2022 providing key insights, projects and lessons in the wider clinical trials space. 2023 will see these lessons merge with long-term trends and the lessons from ...
ByStatsol
About the webinar In this free webinar, we focus on some of the most popular trial design topics covered this year. To see video, please click here In this free webinar you will learn about: Guide to Sample Size Re-estimation in Clinical Trials Unblinded Sample Size Re-estimation Sample Size for Complex Endpoints Sample ...
ByStatsol
Phase 1 studies show improvement in cognitive factors, consistent with therapeutic potential of CY6463 to improve key features in neurological diseases CY6463 favorable tolerability and safety profile was confirmed Ariana Pharma, a leading Artificial Intelligence (AI) drug development company, in collaboration with Cyclerion Therapeutics, presented today safety and pharmacodynamic results ...
If the FDA has no further comments after the 30-day review period, BRIM will proceed to initiate the Phase 3 clinical trial in December. Based on its Preliminary Comments , the FDA has accepted the proposed Phase 3 clinical trial design submitted by BRIM for the End-of-Phase 2 (EOP2) meeting. The Phase 3 ...
About the webinar We explore common challenges faced when designing and conducting clinical trials with sample size re-estimation (SSR). ...
ByStatsol
(“BRIM,” TPEx 6885) is pleased to announce that it has received agreement from the US Food and Drug Administration (FDA) on the Phase 3 clinical trial design for its lead candidate for Dry Eye Disease (DED), BRM421, at the End of Phase 2 Meeting. ...
Ariana Pharma, the leading Al-driven precision medicine company, has announced the first comprehensive blarcamesine pathway analysis impact using extensive data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) clinical study. Initial results were presented by Ariana Pharma at the Alzheimer’s Association International Conference (AAIC 2022) in San Diego, in ...
(BRIM, TPEx 6885) reports that the Company’s Board of Directors has approved a proposal for a seasoned equity offering, following its recent emerging stock market (ESM) listing, to increase capital and advance its lead drug candidate, BRM421, to late-stage clinical trials for dry eye syndrome (DES). The Board of Directors gathered for an interim meeting ...
About Flamingo-01 and GLSI-100 Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant ...
Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. ...
Ariana Pharma, the leading eXplainable Artificial Intelligence (xAI) drug development company, announce the appointments of Dr. Marion Soto as Vice President, Business Development and Bertrand Lellouche as Chief Financial Officer. The financial and commercial experience of Marion and Bertrand will further drive Ariana’s accelerated growth. Marion and Bertrand will be bringing their ...
Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure ...
Jiajun and Mike strengthen our clinical development team and, working with Chief Medical Officer Dr. Brett Lauring, will help drive our continued progress. ...
FDA Orphan Drug Designation reflects urgent need for new therapies for glioblastoma (GBM) patients Next steps for development of VBI-1901 : Q3 2022: Expected initiation of randomized, controlled clinical study in recurrent GBM patients with potential to support accelerated approval application Q4 2022: Expected initiation of randomized, controlled ...
Ariana Pharma and OmiCure announce their collaboration with the renowned CLB Cancer Center to apply OmiCure and Ariana Artificial Intelligence (AI) capabilities to find more efficient treatments for cancer patients. The data were communicated at ASCO 2022 last week and showed that Artificial Intelligence RNA-based therapeutic recommendations have the potential to expand personalized cancer ...