ACT Online
A compilation of ACT's most popular content from the previous month plus a look at upcoming webcasts.
Top 5 Social Media:
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
eLEARNING:
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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
