We have completed various clinical trials for several years.


Regulatory Affairs

With more than 10 years of RA experience and knowledge, we provide regulatory affairs services such as strategy consulting and writing document for approvals of pharmaceutical products and medical equipment.

Our Services

  • Strategic consulting
  • Project Strategic planning
  • Project management
  • Pre-IND meeting
  • IND/IDE submission
  • NDA/MDA submission
  • GMP consulting
  • DMF
  • License In/Out
  • CTD Writing
  • License Holding
  • Import / ExportInvestigational Product
  • Medical Translation

Medical Affair

Our team members who provide professional medical writing services are qualified with Ph.D. and M.D. degrees and have abundant experiences in DM, STAT, CRA and Medical Advisor. Based on the broad experiences in the R&D field, we support the best strategic plan for MFDS approval and marketing of pharmaceuticals and medical equipment.

Our Medical Advisor Group is comprised of Medical Doctors and will provide optimal protocol, clinical study reports and effective solutions for medical issues.

Clinical Operation

Comprised of specialists with abundant experiences in CROs and global and domestic pharmaceutical companies, our clinical research unit offers specialized and customized service to satisfy sponsors with strict compliance with KGCP and ICH-GCP guidelines and perform contracts for complete or partial clinical testing.

Our Services

  • Project strategic planning
  • Project management
  • Feasibility
  • Investigator / Site Identification
    & qualification
  • Pre-study visit
  • Investigator meeting
  • IRB submission
  • Initiation activities
  • Site personal training
  • Site monitoring activities
  • Close-out activities


Based on extensive hands-on experience know-how accumulated through our projects in Korea, Japan and through our global studies, we provide services for developing and validating paper CRFs as well as e-CRFs. Further, through accurate statistical analysis and data management, we offer premium Data Management/Statistics services such as Phase I~IV studies, Investigator Initiated Trials (IIT), Observational Studies, Post Marketing Surveillance, etc..

Our Services

  • Data Management
  • Data Management Plan (DMP)
  • DB Structure
  • Data Validation Specification
  • Data Entry Screen (DES)
  • Double entry
  • Medical coding
  • Database Quality Check
  • Database Lock
  • Data Transfer
  • Archiving
  • Statistical Analysis
  • Randomization support
  • Sample size estimation
  • Designing statistical analysis
  • Preparing statistical reports
    interim, DSMB,
    final and clinical study reports
  • Consulting on statistical
    methodology and statistical


We provide all types of Post Marketing Surveillance (PMS) services including re-examination reports, annual and periodic reports, Pharmacovigilance.

Our Services

  • PMS Study Design
    (Protocol & CRF development)
  • Feasibility check and Contract
  • Data management planning
  • Data Entry/Query Management
  • Designing statistical analysis
  • Regulatory Affairs (MFDS/IRB)
  • Investigator & Site selection
  • Safety Management
  • Discussion & contract with
  • Management of study cost
  • Preparation for
    surveillance Initiation
  • Safety reporting
  • Periodic, Annual and
    Final Reporting
  • Re-examination
  • Preparing statistical reports


We provide all types of Post Marketing Surveillance(PMS) services including re-examination reports, annual and periodic reports, Pharmacovigilance and Marketing promotion PMS.

Our Services

  • IRB Submission
  • Project Management
  • Site Personal Training
  • Data Collection & Monitoring

Global Study Support

We offer the optimal clinical trials services for launching your product in various countries with the collaboration of local CROs in each country.

Our Services

  • Consulting Service
  • Feasibility Service
  • CRO/Vendor Assessment Service
  • Regulatory Affairs/Clinical Trial Project Management Service

Quality Assurance

Seoul CRO operates an independent QA department that performs quality checks, processing evaluations and reviews of data and reports for in-house clinical tests as well as auditing services for clinical tests performed by our clients. Further, through accurate SOP management we take charge of clinical trial and Quality Management.

Our Services

  • Project Audit
  • In-house Audit
  • On-site Audit
  • Sponsor Audit
  • For-cause Audit
  • CRO Audit
  • System Audit

Quality Control

Quality control is a key to achieve the successful clinical trial result. Seoul CRO provides Quality Control service to ensure all parties involved in clinical trials to perform his or her respective tasks with strict compliance with KGCP and ICH GCP guidelines.

Our Services

  • Staff Training
  • GCP Training
  • Co-Monitoring
  • SOP Training
  • TMF Review