BlueCloudX® Industry Standards Multilingual Regulatory Downloads

 

Training for Researchers

 

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®.

 

“Synopsis from Regulatory Agencies, Sponsors, CROs, Universities, IRBs and other Life and Health Sciences Industry Stakeholders – How Following Proper Standards Can Minimize and Ultimately Eliminate Warning Letters from the FDA”

Synopsis-FollowingProperStandards

 

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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:

DOWNLOADABLE “AUDIT READY” GLOBALLY STANDARDIZED TRAINING & CERTIFICATION PROCESSES FOR HEALTHCARE & CLINICAL RESEARCH PROFESSIONALS, SPONSORS, CROs, SITES, HOSPITALS AND ALL OTHER LIFE SCIENCES BASED STAKEHOLDERS

Self Manage Self Test (SMST)
National Institutes of Health Stroke Scale (NIHSS)
Modified Rankin Scale (mRS)
Columbia-Suicide Severity Rating Scale  (C-SSRS)
Barthel Index (BI)
Fugl Meyer Arm/Leg Scales (FMA / FML)
Rankin Focused Assessment (RFA)
Action Research Arm Test  (ARAT)
Gait Velocity (GV)
Motricity Index (MI)
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs (FDA Guidance)
Additional Industry Guidances
New Guidance on the Conduct of Clinical Trials during Public Health Emergencies in the EU