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We Creates
Value For
Human Life

intoinworld was established in 2015 and is a Contract Research Organization (CRO) to promote the growthof the clinical trial field through the gathering of experts who have been engaged in clinical trials for many years.

  • SET UP
    • Protocol/CRF/ICF Development & Review
    • Study Material Development
    • Investigator’s Meeting
    • MFDS/IRB Submission & Approval
    • Feasibility Interview & Reporting
  • MONITORING
    • Monitoring Plan
    • Initiation Meeting
    • Essential Document Management
    • Clinical Supply Management
    • Regular Monitoring/SDV
    • Close-out Monitoring
  • PROJECT MANAGEMENT
    • Project Management Plan
    • Study Personnel Training
    • Overall Management
    • Clinical Trial Report
    • AE/SAE Report
    • IP Handling
    • Site Management
  • REGULATORY AFFAIR
    • MFDS IND Approval
    • MFDS NDA Approval
    • IRB Affair
    • Regulatory Consultation
  • DATA MANAGEMENT
    • Data Management Plan
    • Database Design
    • Data Entry
    • Data Verification & Validation
    • Medical Coding
    • Data Locking
  • STATISTICAL ANALYSIS
    • Statistical Analysis Plan
    • Programming & Analysis
    • Generating Tables & Figures
    • CSR Body & Translation
  • MEDICAL WRITING
    • Protocol
    • Informed Consent Forms
    • Clinical Study Reports
    • Common Technical Documents (CTD)
    • Clinical Sections of New Drug Applications (RA)
  • QUALITY ASSURANCE
    • Audit Plan
    • Audit Report
    • SOP Development & Management
    • Good Clinical Practice Auditing
    • Good Clinical Laboratory Practice Auditing
    • Good Pharmacovigilance Auditing
    • Due Diligence
    • Vendor-Contractor Management
    • Audit CAPA Management
  • PHARMACOVIGILANCE
    • SAE Processing
    • Safety Report Production
    • SAE/SUSARs Reporting to Regulatory Authorities
    • SAEs Reconciliation
    • SUSAR (Suspected Unexpected Serious Adverse Reaction)
    • Handling
    • Development and Maintenance of Pharmacovigilance
    • Management and Maintenance of Safety Database
    • Pharmacovigilance Training
    • Program Development
    • SMP (Safety Management Plan)
    • RMP (Risk Management Plan)

We Creates
Value For
Human Life

intoinworld was established in 2015 and is a Contract Research Organization (CRO) to promote the growthof the clinical trial field through the gathering of experts who have been engaged in clinical trials for many years.

SET UP
  • Protocol/CRF/ICF Development & Review
  • Study Material development
  • Investigator’s Meeting
  • MFDS/IRB Submission & Approval
  • Feasibility Interview & Reporting
MONITORING
  • Monitoring Plan
  • Initiation Meeting
  • Essential Document Management
  • Clinical Supply Management
  • Regular Monitoring/SDV
  • Close-out Monitoring
PROJECT MANAGEMENT
  • Project Management Plan
  • Study Personnel Training
  • Overall Management
  • Clinical Trial Report
  • AE/SAE Report
  • IP Handling
  • Site Management
REGULATORY AFFAIR (RA)
  • MFDS IND Approval
  • MFDS NDA Approval
  • IRB Affair
  • Regulatory Consultation
DATA MANAGEMENT
  • Data Management Plan
  • Database Design
  • Data Entry
  • Data Verification & Validation
  • Medical Coding
  • Data Locking
STATISTICAL ANALYSIS
  • Statistical Analysis Plan
  • Programming & Analysis
  • Generating Tables & Figures
  • CSR Body & Translation
MEDICAL WRITING
  • Protocol
  • Informed Consent Forms
  • Clinical Study Reports
  • Common Technical Documents (CTD)
  • Clinical Sections of New Drug Applications (RA)
QUALITY ASSURANCE
  • Audit Plan
  • Audit Report
  • SOP Development & Management
  • Good Clinical Practice Auditing
  • Good Clinical Laboratory Practice Auditing
  • Good Pharmacovigilance Auditing
  • Due Diligence
  • Vendor-Contractor Management
  • Audit CAPA Management
PHARMACOVIGILANCE
  • SAE Processing
  • Safety Report Production
  • SAE/SUSARs Reporting to Regulatory Authorities
  • SAEs Reconciliation
  • SUSAR (Suspected Unexpected Serious Adverse Reaction)
  • Handling
  • Development and Maintenance of Pharmacovigilance
  • Management and Maintenance of Safety Database
  • Pharmacovigilance Training
  • Program Development
  • SMP (Safety Management Plan)
  • RMP (Risk Management Plan)

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