A compilation of ACT's most popular content from the previous month plus a look at upcoming webcasts.
How Does FSP Models Complement eSource Implementation?
A Competency-Based Approach to Combating the Talent Wars in BioPharma
Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical Trial
Adapting Monitoring Models During COVID-19
Decentralized Trials: Opening New Opportunities in Clinical Research
Prioritizing in the New Normal
Throughout the global COVID-19 pandemic, clinical research activity has morphed and changed through the shut down and eventual reopening of research sites and studies. During this webcast, experts will discuss how to prioritize in this “new normal”, whether that involves reopening sites, catching up on a backlog of work, or fully implementing remote capabilities. In addition, we plan to discuss some of the important aspects of clinical trial management from a sponsor/CRO level and what mindset shifts may need to occur to proactively create study plans. A few areas of focus will include resuming activity for ongoing studies, planning upcoming studies, and adjusting budgets for sites and CRO teams.
Information Systems in Clinical Trials: Pragmatic Validation of EDC Systems
Computer System Validation is a key regulatory requirement and one which challenges the understanding and resources of many research organizations. Achieving the validated state means managing an ever-changing environment of servers, operating systems, EDC software, security patches etc, some or all of which may be outside the direct control of the organization. And all this needs consideration before you have even started developing your study database. GCP expects a risk-proportionate approach, but how can this be approached pragmatically? During this webcast, experts will explore the scope of EDC system validation and offer practical ways of dealing with change overload and surviving a visit from the inspectors.
The Future of Precision Medicine: How Biomarkers Have Influenced Clinical Trial Designs and Outcomes
Precision medicine has proven to be successful in treating cancers as it is tailored to a patient’s specific needs. Because of this custom approach to treatment, however, planning a clinical trial for precision medicine is markedly more challenging than more conventional treatments, as it must consider patients’ variability in genes. As a result, biomarker use in precision medicine has been critical for defining patient segments, selecting trial locations, and measuring trial success.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.