Clinical Development

  • Medical Writing
  • Clinical Operation
  • Late Phase Study
  • Data Management
  • Biostatistics
  • Regulatory Affairs

  • About Service

    Our medical writers have strong scientific knowledge in most major therapeutic areas and develop clinical study design and protocols, document clinical study reports in compliance with guidelines such as MFDS, FDA, ICH-GCP/KGCP and EMA.
    We offer medical support, in close collaboration with our Clinical Operation, Biostatistics and Data management teams to ensure high-quality data and on-time reporting of study deliverables.

    Service scope
    • Preparation of clinical trial documentation
    • Study synopsis and protocol development
    • Investigator brochures
    • Informed consent forms and other patient material
    • Preparation/adaptation of clinical documentation
    • Clinical study reports
    • CTD (Common Technical Document)
    • Conference Presentation Support
    • Medical and scientific literature reviews
    Service process
    Protocol development
    • discuss with client
    • research the paper
    • design and development
    • internal QC
    • client review and approval
    • develop the protocol
    CSR development
    • Study
      assignment
    • review
      the protocol
    • statistical analysis protocol
      and collected data
    • writing the CSR
    • internal QC
    • client review
      and approval
    • CSR finalization

  • About Service

    HYUNDAI ADM BIO provides excellent clinical trial-field service in the global standards of all the phases, serving the best quality that has reduced risk and the cost within your desired project milestone.

    1) Comply with ICH-GCP and KGCP guidelines.
    2) Have extensive global and local clinical research experience.
    3) Have a high quality of infrastructure.

    • Project Management

      Serving the best quality and speedy- progress throughout the Proactive Risk Management and Issue & Quality Management by the experts over 10 years careers in the fields of clinical trials.

    • Clinical Monitoring and Site Management

      Serving the professionalized Clinical Monitoring and Site Management Services by CRAs perfectly trained by CRA Line Managers practice accredited internal Clinical Trial Monitoring Education Courses and CRA Training Programs.

    • Study Start-Up

      Serving the best clinical trial set-up with the prompt systematic plans by the specialized team that has wide experience with the diverse Clinical Trial Sites.

    • Quality Control

      Carrying out regular Quality Controls for qualifying the projects to be complied with protocols, SOPs and GCPs by project-QC visits of specialized QC team.

    Service Scope
    • Investigator’s meeting
    • Feasibility
    • Site Qualification Visit
    • IRB Submission
    • Site Contract
    • PMP, MP, DoMP, SRP etc.
      development
    • Initiation, interim monitoring,
      and study close-out visits
    • Essential document management
      (collection, review, archive, etc.)
    • Clinical Supply management
    • Communication with site staffs
    • Study specific training to site personnel
    • Safety Management
    • Pharmacy monitoring
    • Query Management
    • Inspection Preparation
      & Correspondence
    Service process
    a big view

  • About Service

    HYUNDAI ADM BIO has experts with extensive experience in the operation and audit of local and global projects and various therapeutic areas and has expertise through internal learning management systems to provide optimal service to customers based on a high level of understanding of the project.

    Strength
    • HYUNDAI ADM BIO has a separate SOP with a dedicated business unit for Late Phase Study to provide LPS-specific services and good business support.
    • HYUNDAI ADM BIO provides fast and high-quality services through experts with extensive experience in the operation and audit of local and global projects and various therapeutic areas.
    • HYUNDAI ADM BIO provides the most optimized services to meet the specific and varied needs of clients in accordance with the latest regulations and guidelines for study.
    • Our learning management systems, including regulations and guidelines, work-related and disease training, provide the best service for your needs based on a high level of understanding of your projects.
    Service Scope
    • Late Phase Study Operation
      • Project Management
      • Feasibility Activities
      • IRB Affairs
      • Site Contract and Payment
      • Site Visits
      • Safety Management
      • Site Management
      • Document Management
    • Medical Writing for LPS
      • Protocol Development
      • ICF Development
      • CSR Writing
      • Periodic/Re-examination Report Writing

  • About Service

    The HYUNDAI ADM BIO Data Management Team provides professional and reliable services from CRF Development, Clinical Trial System Set-up, Data Management, Centralized Statistical Monitoring and CDISC standards based on extensive practical experience and efficient process in various Clinical Study such as Post Marketing Surveillance and Medical Devices as well as clinical trials and therapeutic area. Especially, personnel with experience in R&D of clinical trial solutions provide qualified service by performing EDC Build and Data Validation Programming using C# and SAS Programming.

    (Clinical Data Management System:
    - CRScube: cubeCDMS, cubePRO
    - Medidata: Rave EDC, RTSM, eCOA)

    Service Scope
    • CRF/CRF Completion
      Guideline Development
    • Data Management Plan
    • Customized Database
      Design and Validation
    • Data Validation and
      Query Management
    • Data Review Listings for
      study whole data
    • Medical Coding (MedDRA, WHOATC,
      WHODrug Global etc.)
    • SAE Reconciliation
    • External Data Management
    • Protocol Deviation List Generation
    • Database Quality Control
    • Database Lock
    • Data Management Report
    • Electronic Data Transfer
    • CDISC SDTM
      (Study Data Tabulation Model)
    • CSM (Centralized Statistical Monitoring)
      based RBM
    Service process
    a big view

  • About Service

    The HYUNDAI ADM BIO Biostatistics Team provides professional and reliable services from Study design, Sample size Calculation, Randomization, Statistical analysis plan, statistical Analysis Result, Statistical Analysis Report to CDISC standards based on extensive practical experience and efficient process in various Clinical Study such as Clinical Trial, Post Marketing Surveillance and Medical Devices, etc. and therapeutic area.

    Service Scope
    • Statistical Study Design and
      Sample Size Calculation
    • Statistical Analysis Strategies
    • Randomization
    • Statistical Analysis Plan
    • Dry-Run Process
    • Statistical Analysis Programing
    • Tables, Figures and Listings
    • Statistical Analysis Report
    • CDISC ADaM (Analysis Data Model)
    • RWD/RWE Studies
    Service process
    a big view

  • About Service

    HYUNDAI ADM BIO offers superior quality regulatory services so that product development can be carried out efficiently and effectively. ADM regulatory experts with experience in a variety of fields from the initial development of pharmaceutical/medical device to approval and high regulatory understanding suggest the proper regulatory strategy to help clients register product efficiently.

    Service Scope
    • Strategic and Regulatory Drug
      Development Consulting
    • Preparation and Document
      Validation of Registration Dossier
    • IND & NDA Application Support
    • Scientific and Medical
      Communication with
      Regulatory Authorities
    • Post-Approval Maintenance Support
    Service process
    • Regulatory Strategy for
      Drug development
    • Package Preparation
    • Submission
    • Regulatory
      authority review
    • Follow up during regulatory
      authority review process
    • Approval & Post-Approval
      management