Business

Intoinworld Co., Ltd; a company that always puts people first

CLINICAL TRIAL(FULL SERVICE)

  • SET UP

    Intoinworld Co., Ltd establishes and manages a comprehensive system for clinical trials, covering all stages from initiation to institutional IRB work, document preparation, and institutional contracts. Our dedicated team of professional staff ensures prompt and efficient service delivery, allowing our clients to quickly receive clinical trial and institutional contract services at every stage.

    • Protocol/CRF/ICF Development & Review
    • Study Material Management
    • Investigator’s Meeting
    • MFDS/IRB Submission & Approval
    • Study Material Management
  • MONITORING

    At Intoinworld Co., Ltd, we handle all necessary tasks for conducting clinical trials, including initiation visits, periodic monitoring, and close-out visits. Our specialized personnel conduct thorough monitoring to prevent potential problems and mitigate risks for our clients, providing the best clinical trial service based on reliable data.

    • Monitoring Plan
    • Investigator’s Meeting
    • Essential Document Management
    • Clinical Supply Management
    • Regular Monitoring/SDV
    • Close-out Monitoring
  • PROJECT MANAGEMENT

    Our experienced project managers and Clinical Research Associates (CRAs) oversee all phases of clinical trials, from Phase I to IV, including post-marketing surveillance. They deliver results that comply with relevant regulations, leveraging their extensive clinical practice expertise.

    • Project Management Plan
    • Study Personnel Training
    • Overall Management
    • Clinical Trial Report
    • AE/SAE Report
    • IP Handling
    • Site Management
  • REGULATORY AFFAIR (RA)

    Intoinworld Co., Ltd employs highly skilled professionals who strive to meet client needs by presenting efficient methods and strategic directions for the entire work process, from initial clinical development to new drug approval.

    • MFDS IND Approval
    • MFDS NDA Approval
    • IRB Affair
    • Regulatory Consultation
  • DATA MANAGEMENT

    Intoinworld Co., Ltd provides a full range of data management services, from Case Report Form (CRF) development to Clinical Data Management (CDM) setup, operation, and data lock. We offer comprehensive data management services across Phase I to IV trials, Observational Studies (OS), Investigator-Initiated Trials (IIT), and Post-Marketing Studies (PMS).

    • Data Management Plan
    • Database Design
    • Data Entry
    • Data Verification & Validation
    • Medical Coding
    • Data Locking
  • STATISTICAL ANALYSIS

    Our statistics experts at Intoinworld Co., Ltd deliver optimized clinical trial statistical analysis results that adhere to clinical trial management standards. By prioritizing effectiveness and stability in analysis design, data analysis, and statistical interpretation, our experts ensure high-quality outcomes based on their practical experience.

    • Statistical Analysis Plan
    • Programming & Analysis
    • Generating Tables & Figures
    • CSR Body & Translation
  • MEDICAL WRITING

    The Medical Writing team at Intoinworld Co., Ltd provides systematic services for research, encompassing task planning and support from Phase I through IV, essential for practical consulting and pharmaceutical product development.

    • Protocol
    • Informed Consent Forms
    • Clinical Study Reports
    • Common Technical Documents (CTD)
    • Clinical Sections of New Drug Applications (RA)
  • QUALITY ASSURANCE

    Our Quality Assurance (QA) team is dedicated to managing quality from Phase I to IV and post-marketing stages. They offer inspection and consulting services that meet regulatory agency requirements, drawing on extensive professional knowledge and experience.

    • Audit Plan
    • Audit Report
    • SOP Development & Management
    • Good Clinical Practice Auditing
    • Good Clinical Laboratory Practice Auditing
    • Good Pharmacovigilance Auditing
    • Due Diligence
    • Vendor / Sub-contractor Management
    • Audit CAPA Management
  • PHARMA COVIGILANCE

    With extensive experience in clinical trials and post-marketing surveillance, as well as practical expertise in medical and safety information management databases, Intoinworld Co., Ltd is committed to maintaining advanced drug safety in diverse regulatory and development environments. Our team leverages experience with regulatory agencies and continuous education to provide the best Pharmacovigilance (PV) services to our clients.

    • SAE Processing
    • Safety Report Production
    • SAE/SUSARs Reporting to Regulatory Authorities
    • SAEs Reconciliation
    • Suspected Unexpected Serious Adverse Reaction (SUSAR) Handling
    • Development and Maintenance of Pharmacovigilance
    • Management and Maintenance of Safety Database
    • Pharmacovigilance Training
    • Program Development
    • Safety Management Plan (SMP)
    • Risk Management Plan (RMP)

PMS/OS/IIT

  • POST MARKETING
    SURVEILLANCE (PMS)
    • Consulting
    • Study Design
    • Protocol/CRF Development & Review
    • IRB Submission & Approval
    • Personnel Training
    • Project Management
    • Data Collection & Monitoring
    • Safety Report & Management
    • Data Entry & Query Management
    • Statistical Analysis
  • OBSERVATION STUDY
    (OS)
    • Protocol/CRF Development & Review
    • IRB Submission & Approval
    • Study Material Development
    • Personnel Training
    • Project Management
    • Data Collection & Monitoring
    • Safety Report & Management
    • Data Entry & Query Management
    • Statistical Analysis
  • Investigator
    Initiated Trial (IIT)
    • IIT Study Design (Protocol & CRF)
    • Study Preparation & IRB Submission
    • Investigational Staff Training
    • Project Management
    • Monitoring (On-Site Education)
    • DCF Verification And Project Management
    • IIT Reporting