ACT Online

Applied Clinical TrialsApplied Clinical Trials-09-01-2020
Volume 29
Issue 9

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


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.

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