SERVICE SCOPE

㈜프로메디스는 ICH GCP 및 KGCP 규정을 준수하여 고객에게 최적화된 수준 높은 임상시험 전략과 설계를 제공하고
숙련된 임상시험 전문가들과 최적의 임상시험 서비스를 제공하여 고객과 윈윈 할 수 있는 임상 연구 분야에서 최고의 CRO가 될 것입니다.

01 CORE SERVICE FIELDS

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02 MEDICAL & REGULATORY AFFAIR

  • Medical writers with master’s and Ph.D. with various experience in clinical trials fields develop clinical documents such as Protocol and Clinical Study Report through cooperation with clinical operation team and DM team. Experienced Statisticians support statistical work such as sample size calculation and statistical methodology technology.

  • Study Document Development and Validation

  • Clinical Study Reports

  • Protocol, ICF, Publications, Posters

03 CLINICAL OPERATIONS

Experts from multinational/domestic pharmaceutical companies and CRO provide high-quality clinical trial service based on ICH-Guideline and KGCP.

  • 포인트

    Project Strategic Planning

  • 포인트

    Project Management

  • 포인트

    Feasibility & Investigator Site Selection

  • 포인트

    Budget Negotiation & Management

  • 포인트

    Investigator Meeting

  • 포인트

    Initial IRB Submission

  • 포인트

    Site Contract

  • 포인트

    Site Initiation Activities

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    Site Monitoring Activities

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    Close Out Activities

  • 포인트

    MFDS Inspection Support

  • 포인트

    Quality Control

04 DATA MANAGEMENT

Based on accumulated knowledge from long working experience, we provide the highest quality of DM service through statistical development planning, analysis, and data management.

  • 포인트

    Data Management Plan Development

  • 포인트

    Case Report Form Development

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    Data Dictionary Development

  • 포인트

    Data Validation Specification Development

  • 포인트

    Electronic Data Capture Setup and Validation

  • 포인트

    Electronic Data Capture Management

  • 포인트

    Paper-based CRF Management with Data Entry

  • 포인트

    External Data Management

  • 포인트

    DSMBs Participation

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    Clinical Data Review

  • 포인트

    Medical Coding using MedDRA, WHOART, WHODD etc.

  • 포인트

    Database Quality Check

  • 포인트

    Serious Adverse Event Reconciliation

  • 포인트

    Database Lock

  • 포인트

    Protocol Violation List Generation

  • 포인트

    Data Transfer

  • 포인트

    Archiving

05 STAT TEAM(BIOSTATISTICS)

Biostatistics supports the design of clinical research, determining the sample size, random, CDSIC ADaM support, statistical analysis (double programming), statistical reports, and statistical consultation.

  • 포인트

    Consulting on Statistical Epidemiology and Statistical Methodology

  • 포인트

    Sample Size Estimation

  • 포인트

    Statistical Method Design

  • 포인트

    Randomization Plan Development

  • 포인트

    Statistical Analysis Plan Development

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    Statistical Analysis Programming

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    Statistical Analysis Results(TFLs) Preparation with Interim, DSMBs, Final

  • 포인트

    Subject Listing

  • 포인트

    Archiving

06 QA/QC

  • Quality improvement and quality assurance of clinical trials are provided through Audit and SOP management by QA/QC team. Overall quality management through thorough SOP management is also provided.

  • Quality assurance and management is considered more important than ever in clinical trials. Promedies provides accurate and reliable quality assurance in response to ICH GCP and KGCP.

  • 포인트

    In-house Audit

  • 포인트

    On-site Audit

  • 포인트

    Sponsor Audit

  • 포인트

    For-cause Audit

  • 포인트

    System Audit

  • 포인트

    Vendor Assessment

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