2022 brought many healthcare advances and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.
So here, in case you missed them, are the most sought-after articles, white papers, webinars, and more produced by Calyx scientific, technical, and regulatory experts this year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.
This blog series addresses the trigger points for unintentional unblinding, how partial unblinding can become full unblinding, and some controversial issues related to unintentional and partial unblinding in clinical trials.
In 2021, Calyx advanced its strategy of partnering with best-in-class technology providers to offer innovative imaging biomarkers required to find new treatments for unmet medical needs. Our groundbreaking partnership with Qynapse enables our clients to more confidently assess the full potential of treatments in development for Multiple Sclerosis, Parkinson’s, Alzheimer’s, and Huntington’s disease, as well as other neurodegenerative disorders. And our partnership with Neosoma delivers novel, improved AI-based neuro-oncology imaging assessment to clinical trial sponsors developing new treatments for gliobastoma and other life-threatening neuro-oncological diseases.
The Journal for ImmunoTherapy of Cancer recently published ‘Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival,’ marking the first time immune-related criteria show correlation with Overall Survival as its most meaningful endpoint in the treatment of cancer patients.
The publication demonstrates the benefit to a subgroup of patients who otherwise would have foregone treatment and survival benefit when relying solely on RECIST 1.1 instead of irRECIST, as irRECIST takes the entire tumor burden including new tumor growth into consideration.
In this webinar, co-authors Peter Eggleton of Merck and Oliver Bohnsack of Calyx – leading experts on RECIST and irRECIST – discuss the implications of these findings, what it means for oncology clinical development and treatment decision-making, and why irRECIST easily can and shall replace outdated RECIST 1.1 on all solid tumor trials going forward.
In rare disease trials, it is critical that trial supplies are available when patients are identified, and that drug overage is minimized – a real challenge due to larger numbers of investigative sites typically required to meet trial enrollment levels. Which is why we’re honored that so many sponsors of orphan drug-designated trials have entrusted their RTSM needs to Calyx IRT and continue to rely on our expertise as they bring safe and effective treatments to patients in critical need. Learn more about Calyx IRT.
This blog series reviews the factors regulatory affairs professionals should consider as they prepare for eCTD 4.0 implementation, beginning with people and business processes, the impacts of new concepts and terminologies, and the challenges to be expected.
What are the consequences of deferring IRT functionality to meet clinical trial start dates? In this Applied Clinical Trials article, Calyx’s Craig Mooney reviews the inefficiencies and potential quality / regulatory risks likely to occur.
At Calyx, we have a long history as part of a CRO, so we know how a CRO functions, the challenges you’re up against, and the importance of keeping your customers satisfied. This inside knowledge affects every aspect of our CRO relationships and makes us more efficient and easier to work with.
Our Activate Solutions for CRO Partners Program enables CROs of all shapes and sizes to partner with Calyx and extend our advanced technology and proven services to drive success for their customers. In 2022 we added more CROs to the program – get to know some of them and learn how they’re partnering with Calyx to deliver more value.
80 sites enrolling 150 patients: How do you minimize overage without burdening your supply team? Learn how one of Calyx IRT’s advanced trial management options solved the complex in this case study.