Clinical Development & CRO Services
With expert personnel and a systematic operational framework based on KGCP and ICH-GCP standards, we provide integrated services across the entire clinical development lifecycle, from clinical trial planning, operations, data and statistics to quality management.
CORE SERVICE FIELDS
Core Clinical Service Fields
Backed by expert personnel with extensive experience in multinational and domestic pharmaceutical and CRO projects, we provide high-quality clinical trial services that comply with KGCP and ICH-GCP guidelines.
-
Medical Advisor
-
Medical Writer
-
Project Manager
-
Stat Advisor
-
Medical Writing
-
Clinical Operations
-
Data Management
-
Strategic Planning
MEDICAL & REGULATORY AFFAIRS
Medical Writing and Regulatory Approval Support
Through seamless collaboration between master's- and doctoral-level Medical Writers and statistics experts, we provide advanced document development services spanning clinical design, Protocol, CSR and Publications.
Key Services
- Study Document Development and Validation
- Protocol / ICF
- Clinical Study Reports
- Publications / Posters
CLINICAL OPERATIONS
Clinical Operations Service
Based on extensive global and domestic clinical operations experience, we carry out the entire clinical trial operations process, from Project Planning to Site Monitoring and MFDS Inspection.
Key Services
- Project Strategic Planning
- Site Contract
- Project Management
- Site Initiation Activities
- Feasibility & Investigator Site Selection
- Site Monitoring Activities
- Budget Negotiation & Management
- Close Out Activities
- Investigator Meeting
- MFDS Inspection Support
- Initial IRB Submission
- Quality Control
DATA MANAGEMENT
Clinical Data Management
Drawing on accumulated hands-on expertise, we provide high-quality Data Management services spanning EDC, CRF, Validation, Coding and Database Lock.
Key Services
- Data Management Plan Development
- Clinical Data Review
- Case Report Form Development
- Medical Coding using MedDRA, WHOART, WHODD etc.
- Data Dictionary Development
- Database Quality Check
- Data Validation Specification Development
- Serious Adverse Event Reconciliation
- Electronic Data Capture Setup and Validation
- Database Lock
- Electronic Data Capture Management
- Protocol Violation List Generation
- Paper-based CRF Management with Data Entry
- Data Transfer
- External Data Management
- Archiving
- DSMBs Participation
STAT TEAM (BIOSTATISTICS)
Clinical Statistical Analysis
We provide professional Biostatistics services spanning clinical trial design, sample size estimation, randomization, statistical analysis and TFLs preparation.
Key Services
- Consulting on Statistical Epidemiology and Statistical Methodology
- Statistical Analysis Programming
- Sample Size Estimation
- Statistical Analysis Results(TFLs) Preparation with Interim, DSMBs, Final
- Statistical Method Design
- Subject Listing
- Randomization Plan Development
- Archiving
- Statistical Analysis Plan Development
QA/QC
Quality Assurance and Quality Control
Through Audits compliant with KGCP and ICH-GCP standards and SOP-based quality management, we ensure the accuracy and reliability of clinical trials.
Key Services
- In-house Audit
- For-cause Audit
- On-site Audit
- System Audit
- Sponsor Audit
- Vendor Assessment