Intoinworld, a company that always puts people first


  • SET UP

    “intoinworld” establishes and manages a management system from the initiation stage of clinical trials to institutional IRB work, document preparation, institutional contracts, etc. through a dedicated team of professional staff, enabling prompt and efficient service provision. We ensure that our clients can quickly receive clinical trial work and institutional contract services at all stages.

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

    “intoinworld” performs overall tasks necessary for conducting clinical trials, such as clinical trial initiation visits, periodic monitoring, and close out visits, through monitoring conducted by specialized personnel, and prevents potential problem in advance to prevent risks to the client and provides the best clinical trial service based on reliable data results.

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

    “intoinworld”, project Managers and CRAs with years of clinical practice experience and expertise deliver all phases of clinical trials, from Phase I to IV, post-marketing surveillance use results investigation, to the client with results that comply with relevant regulations, based on their expertise.

    • Project Management Plan
    • Study Personnel Training
    • Overall Management
    • Clinical Trial Report
    • AE/SAE Report
    • IP Handling
    • Site Management

    “intoinworld”, highly skilled professionals are making efforts to derive results that meet the needs of the client by presenting efficient methods and strategic directions for the overall work process from initial clinical development to new drug approval.

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

    “intoinworld” advance professionals provide a full range of data management services from Case Report Form (CRF) development to CDM set-up, operation, and data lock, and provide data management services such as Phase I to IV, Observational Study (OS), Investigator-Initiated Trial (IIT), and Post-Marketing Study (PMS).

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

    “intoinworld” statistics experts provide optimized clinical trial statistical analysis results that meet the clinical trial management standards by prioritizing effectiveness and stability in analysis design, data analysis, and statistical analysis based on their practical experience.

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

    “intoinworld” Medical Writing team provides systematic services for research ranging from task planning to Phase I – IV, which is required 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)

    “intoinworld“ Quality Assurance (QA) team is responsible for quality management from Phase I to IV and post-marketing use results and provides inspection and consulting services based on the requirements of regulatory agencies based on 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

    “intoinworld” has extensive experience in clinical trials and post-marketing surveillance and practical experience in medical expertise and safety information management databases. It also strives to maintain advanced drug safety in various regulatory and development environments through work experience with regulatory agencies and continuous education and provides the best PV services to 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)


    • 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
    • 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