A Great Divide: Sponsors Clash With FDA on Trial Data Excess
A new study, conducted collaboratively by the Tufts Center for the Study of Drug Development (Tufts CSDD), the FDA,...
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DCTs and Secrets To Securing Wearables Data
Decentralized Clinical Trials (DCTs) are pioneering a shift towards a more patient-centric approach in clinical research by leveraging the...
Decentralized Clinical Trials: Big Pharma’s New Frontier
In a recent webinar, industry luminaries including Harpreet Gill from ICON plc, Jane Twitchen from Biogen, Angela May from...
Clinical Trial Patient Engagement and Experience Data: Why It’s Vital
A significant shift towards prioritizing clinical trial patient engagement (PE) and patient experience data (PXD) is palpable in clinical...
CRO Performance: A Forgotten Voice of The Site’s Perspective
Contract Research Organizations (CROs) and vendors stand as pillars in clinical trials, with sponsors thoroughly building Key Performance Indicators...
Navigating Compassionate Use in Clinical Research: Unpacking FDA’s Latest Guidance
Compassionate use, also known as expanded access, is a critical pathway for patients with life-threatening conditions to access investigational...
The Role of Clinical Research Associates and the Site’s Responsibility in Regulatory Compliance for Clinical Trials
Clinical Research Associates (CRAs) are integral to the clinical trial process, overseeing that study sites comply with protocols, Good...