Clinical CRO

SERVICES

Regulatory registration
    Regulatory strategy consulting
    Preparation and submission of CTA/IND/NDA/ANDA/BLA documents

    Review and organization of CTD format documents (Modules 1 to 5)

    Assistance in responding to review issues, organizing and reviewing supplementary materials for submission
    Pre-lND/NDA Meeting materials preparation/review and assistance in attending meetings

    Writing of non-clinical summaries, non-clinical text summaries, and list summaries

    Assessment of post-marketing changes during clinical research, organization and review of supplementary application     materials for submission
Medical Affairs
    Writing of clinical development plans and clinical summary documents

    Design and writing of Phase l, ll, lll clinical trial protocols

    Design and writing of llT/POC/Phase 0 clinical trial protocols

    Writing of Phase lV/RWS/PMS clinical trial protocols

    Writing of clinical study reports
    Design and production of investigator's brochures and informed consent forms Medical monitoring of Phase clinical     trials
    Translation and organization of medical materials and literature

    iDMC/CEC medical support
Clinical Operations

    Project management and monitoring of new drug clinical trials, including Phase l, ll, l, lV clinical trials

    Project management and monitoring of bioequivalence clinical trials

    Project management and monitoring of investigator-initiated clinical research

    Project management and monitoring of real-world clinical research

Quality Control
    GCP/GCLP audits
    GCP/GCLP training
    Supplier quality control GCP system alignment at clinical centers

Data Management/Statistics