BlueCloudX® Industry Standards Multilingual Regulatory Downloads

Committed to Evidence-Based Medicine, Gold-Standard Science and Common Sense Approach to Patient, Subject and Public Safety

Over the last 20+ years, BlueCloudX® has developed “National and International Industry Standards Through Crowd Sourcing”.  These global standards  have now proven to minimize fraud, waste, abuse, and redundancies for healthcare and clinical research professionals, national and international industry stakeholders, including but not limited to governments, research sites, hospitals, pharma, medical device, biotech, digital sponsors, universities as well as technology companies.  The standards minimize data variance in clinical trials, with an overarching goal to develop a globally interconnected system that provides access to patients no matter race, religion, socio-economic status, political affiliation or geographical location. A global system that leaves no patient behind®.

FDA 2025 Investigations Operations Manual (IOM)

FDA Remote Regulatory Assessments (RRAs)

WHO Guidance for Best Practices for Clinical Trials

Global Visionaries, Compliance, Privacy and Scientific Key Opinion Leaders (KOLs) Video Interviews

European Medicines Agency (EMA) – Clinical Trial Information System (CTIS) User Guidance on the Sponsor’s Workspace

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Below are some of the industry standards which have now become globally accepted by over 2.6+ million healthcare and clinical research professionals from over 550,000 organizations in 193 countries:

GLOBALLY STANDARDIZED TRAINING & CERTIFICATION PROCESSES FOR HEALTHCARE & CLINICAL RESEARCH PROFESSIONALS