프로메디스

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

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.

Project Strategic Planning
Project Management
Feasibility & Investigator Site Selection
Budget Negotiation & Management
Investigator Meeting
Initial IRB Submission
Site Contract
Site Initiation Activities
Site Monitoring Activities
Close Out Activities
MFDS Inspection Support
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.

Data Management Plan Development
Case Report Form Development
Data Dictionary Development
Data Validation Specification Development
Electronic Data Capture Setup and Validation
Electronic Data Capture Management
Paper-based CRF Management with Data Entry
External Data Management
DSMBs Participation
Clinical Data Review
Medical Coding using MedDRA, WHOART, WHODD etc.
Database Quality Check
Serious Adverse Event Reconciliation
Database Lock
Protocol Violation List Generation
Data Transfer
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.

Consulting on Statistical Epidemiology and Statistical Methodology
Sample Size Estimation
Statistical Method Design
Randomization Plan Development
Statistical Analysis Plan Development
Statistical Analysis Programming
Statistical Analysis Results(TFLs) Preparation with Interim, DSMBs, Final
Subject Listing
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.

In-house Audit
On-site Audit
Sponsor Audit
For-cause Audit
System Audit
Vendor Assessment

Service Scope