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Research Support

Traditional Korean medicine center clinical trials leading to the era of the 21st century, traditional Korean medicine

Salient Features

Management of Investigational Products

  • • Calculating and submitting estimates of IP management to clients

    • Checking the study protocol

    • Initiating meetings with the investigators and establishing an administration plan

    • IP code generation

    • Packaging and labeling as needed

    • Receipt, storage, and inventory control of IP

    • Preparation of prescription

    • Dispensing and administration of IP

    • Medication counseling and checking compliance

    • Preparing records and storing Trial Pharmacist Files

    • Periodic check-up on the related equipment

    • Preparing for various types of Monitoring, Audit and Inspection

    • Development and periodic revision of the pharmacy’s SOPs

Web-based Clinical Trial Management System

  • • High quality control on clinical data

    • Reduction of performance time of clinical trials

    • Less risk, more efficiency.

    • Prevention of data corruption or loss with a fully secured and backed up system.

    • Perfectly optimized electronic system for case report forms with individualization

    • Education for users (PI, sub-I, CRC, CRA, DM, Sponsor, pharmacist, etc.)

    • Wide range of solutions according to the clinical trials (iCReaT, cubeCDMS, cubeIWRS, cubePRO)

Statistical Support

  • • Clinical study design

    • Statistical analysis planning and advice

    • Sample size calculation

    • Randomization

    • Statistical analysis

    • Data handling and statistical programming

    • Interpretation of statistical results

    • Statistical reporting

    • Review and support for publications

Laboratory Support

    Biological analysis

  • • (Herbal medicine) Cell activity analysis

          - Cytokine/Chemokine
          - Nitric Oxide
          - Hormone

    • Evaluation of anti-bacterial and anti-inflammatory activity in biological material

    • Development and support of basic study for science research Real time PCR

          - Real time PCR
  • Chemical analysis

  • • Confirmation of molecular weight and structure for chemical compounds

    • Setting the quality standard and development of quality control (QC) in herbal medicine

    • Metabolites monitoring of herbal medicine

    • Quantification analysis of herbal medicine

    • Metabolites analysis of herbal medicine in biological material

  • Evaluation of herbal medicine-drug interaction

Monitoring

  • • Verification of the written informed consents

    • Verification of compliance with the approved protocol and amendments

    • Verification of case report forms and the source documents

    • Verification of serious adverse events (AE)

    • Verification of the IPs (storage, supply, and return)

    • Verification of sample managements process and results