How to Optimize Your sIRB Experience
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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Regulatory Pathways: When to Submit a 505(b)(2) or an ANDA
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Empowering Patients Through Education and Advocacy in Cancer Care
In the evolving landscape of healthcare, the role of the patient has shifted from a passive recipient of care
The IND Journey Phase I – Navigating Success
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
The Clinical Development Plan: Executing the Clinical Strategy
This white paper outlines key elements of a CDP, including Treatment population, Demonstration of efficacy, Demonstration of safety, Clinical supplies, and Timing of activities.
Didn’t Expect That to Happen: Events That Must be Reported Promptly to the IRB
Learn what events need to be reported to the IRB after study approval and explore scenarios to help evaluate potentially reportable events.
The Role of Data in Optimizing Clinical Trials: Key Insights for Sites and Sponsors
In the fast-evolving landscape of clinical research, data collection and performance metrics are indispensable tools for enhancing the efficiency
Steps to Implementing a Quality Management System
Steps to Implementing a Quality Management System Making quality not just an expectation, but an intrinsic and foundational element of
The Critical Role Sites Play in the Evolution of Clinical Trials
Drawing on the perspectives of experts from Parexel and Advarra, this white paper explores the evolving role of technology in clinical research and its impact on research sites and study conduct.
Clinical Research in the COVID-19 Era: Methods for Continuity
The COVID-19 pandemic has led to a significant shift in day-to-day research operations. To keep research moving forward, sponsors need to build a solid foundation to support the virtualization of key components of clinical trials. In addition, the industry needs to maintain a participant-centric approach while ensuring participant safety and regulatory compliance throughout the trial.
Special Considerations for Pediatric Trials
Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.