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    • HOME
    • CONTACT US
    • SERVICES
    • Drug Safety & PV Training
    • SPONSORS & CRO PARTNERS
    • PATIENTS
    • 4C Certification Programs
  • HOME
  • CONTACT US
  • SERVICES
  • Drug Safety & PV Training
  • SPONSORS & CRO PARTNERS
  • PATIENTS
  • 4C Certification Programs

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Consultation Club (4Cs) Certification Programs

A. Certified Clinical Monitoring & Oversight Professional (CCMOP™)

This advanced certification program equips clinical professionals with the knowledge and practical tools required to perform high-quality monitoring and independent CRA oversight aligned with ICH-GCP R3 expectations. Participants gain hands-on experience in risk-based monitoring, inspection readiness, and cross-site consistency assessment. Designed for CRAs, CTMs, and sponsor oversight teams, this program strengthens governance and reduces regulatory risk.

Format:

 3 day intensive or 5-module virtual series 

Includes:

 

  • ICH-GCP R2 to R3 Practical Transition
     
  • Sponsor Oversight Responsibilities under ICH GCP
     
  • Risk-Based Monitoring & Targeted Oversight
     
  • Monitoring Report Quality & Consistency Review
     
  • Inspection Readiness & Common Findings
     
  • Case Studies and Scenario Workshops

Outcome:

 Participants receive a 4Cs Certificate in Clinical Monitoring & Oversight and practical tools they can apply immediately. 


B. Certified Sponsor Oversight & Governance Professional (CSOGP™)

Outsourcing does not transfer accountability. This certification program focuses on strengthening sponsor-level oversight of CROs and vendors. Participants learn governance frameworks, oversight metrics, inspection preparation strategies, and proactive risk identification techniques. Ideal for sponsor clinical operations and quality teams seeking inspection confidence.

Target Audience :

Sponsor Clinical Operations, QA, and Vendor Management 

Modules:

 

  • Regulatory Expectations for Sponsor Oversight
     
  • CRO Governance Frameworks
     
  • CRA Performance Assessment
     
  • Cross-Regional Consistency in GCP Application
     
  • Inspection Simulation Exercise

Focus:

 Strengthening sponsor-level oversight of outsourced CROs  

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Consultation Club (4Cs) Certification Programs

C. Certified Medical Monitoring & Safety Oversight Program (CMMSO™).

A physician-led program designed to strengthen medical monitoring capabilities, safety oversight processes, and regulatory alignment. This course provides practical guidance on signal detection, SAE review, escalation pathways, and collaboration with clinical operations.

Target Audience:

 Medical Monitors, Safety Physicians, PV Teams 

Includes:

  

  • Medical Monitor Roles & Responsibilities
     
  • Safety Signal Detection & Escalation
     
  • SAE & SUSAR Review Processes
     
  • Safety Oversight During Inspections
     
  • Collaboration with Clinical Operations

Outcome:

 Participants receive a 4Cs Certificate in Medical Monitoring & Safety Oversight and practical tools they can apply immediately. 


D. Clinical Research Excellence Foundation (CREF™)

A foundational program for clinical professionals entering or advancing within the industry. Covers GCP fundamentals, documentation excellence, communication standards, and global cultural awareness to ensure high-quality trial conduct.

Target Audience :

 Junior CRAs, Study Coordinators, New Clinical Staff 

Modules:

  

  • GCP Fundamentals
     
  • Monitoring Basics
     
  • Communication & Professional Etiquette
     
  • Documentation Excellence
     
  • Cultural Awareness in Global Trials
     

Focus:

 Strengthening the market with much needed CRAs  & CTCs

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