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Articles

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success. 

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

Sponsors are beginning to make their study protocols public as pressure for a COVID-19 vaccine rises.

COVID Advances Clinical Trial Transparency

While not all clinical trial assessments can be done virtually, there are many that can be adapted for virtual use. 

What Clinical Trial Assessments Can Be Done Virtually?

This article highlights how C2N Diagnostics and Firma Clinical Research teamed up to create a successful Alzheimer's diagnostic clinical trial while allowing participants to remain in their homes.

Key Points to Success in Decentralized Alzheimer’s Diagnostic Clinical Trial

Vice President of Global Technology and Product Management, Chris Dailey, and Enterprise Architect at Cenduit LLC, Chris Driver, encourage all sponsors and CROs to take a strategic view of how to make an eClinical ecosystem function at its highest level.

Re-Imagining Integration for Quality Clinical Trials

Forming strategic alliances and collaborating to optimize study design can significantly improve pediatric drug development.

A United Front for Better Pediatric Clinical Trials

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.

Master Protocols in Oncology: A Review of the Landscape

Amid industry feedback that the growing volume and diversity of eClinical data collected for studies is taxing cycle times, two studies highlight the need to optimize protocol design and executional complexity to overcome these data management burdens. 

Surmounting eClinical Data Volume and Diversity

Sponsors should be aware of the significant implications the Addendum is likely to have on clinical trial planning, conduct, statistical analysis, and interpretation.

Estimands and Implications for Sponsors as ICH E9 (R1) Addendum Progresses

Rob DiCicco, VP of Clinical Innovation and Digital Platforms at GSK, will discuss the TransCelerate protocol template initiative in this interview. 

Protocol Design