Our Services
Clinical PK Studies
Bioequivalence Studies for Generic Drugs
- Fasting / Fed Conditions
- Normal Volunteers / Patients
- Single Dose / Repeated Dose
- 2x4 / 3x3 Design for Highly Variable Drugs
Clinical PK Studies for Incrementally Modified Drugs
- Drug Interaction Studies
- Food Effect Studies
- Comparative PK Studies
Investigator Initiated PK Studies in Specific Populations
Service Scope
Study Start-Up
IRB (Institutional Review Board) Initial Submission
Budget Negotiation
Contract Negotiation
Medical Writing
Clinical Development Feasibility and Study Design Consulting
CTD (Common Technical Document) Writing
Protocol and Trial-Related Documents Development
CSR (Clinical Study Report) Writing
Clinical Operation
Trial Designing
Protocol Development
Trial-Related Document Development: CRF (Case Report Form),
ICF (Informed Consent Form), Various Forms, etc.
QC (Quality Control) /QA (Quality Assurance) Activities
Statistical Analysis and CSR (Case Study Report) Writing
Biostatistics
Clinical Study Design, Sample Size Calculation and Analysis Strategies
Randomization and Un-Blinding Process
Statistical Analysis Plan
Generating CDISC (Clinical Data Interchange Standards Consortium)
ADaM (Analysis Data Model) Data
Statistical Output Production
Production of Statistical Analysis Report and Review of CSR
(Clinical Study Report)
Interim Analysis
Participating DSMBs (Data Safety Monitoring Boards)
Regulatory Affairs
Package Preparation & Submission to MFDS (Ministry of Food and Drug Safety)
Follow Up after MFDS Submission
Pre-IND (Investigational New Drug) meeting
Data Management
CRF (Case Report Form) Design Development
DMP (Data Management Plan) Development
DB Spec (Database Specification) Development
DVS (Data Validation Specification) Development
CRF Completion Guideline Development
EDC (Electronic Data Capture) System Validation & Management
Database Design & Validation
Data Validation
Lab Data Handling
External Data Handling
Query Management
Medical Coding : MedDRA (Medical Dictionary for Regulatory Activities), K-MedDRA
Data Quality Control
Violation List Generation
Database Lock
Data Transfer
SDTM (Study Data Tabulation Model)
Data Back-Up & Archiving
Consulting
Early-Phase Trial Designing
Protocol Development
Trial-Related Document Development: CRF (Case Report Form),
ICF (Informed Consent Form), Various Forms, etc.
Patient-Based Early-Phase Trial Research Team Construction
New Therapeutics Regulatory Affairs: Cell Therapy, Gene Therapy, etc.
Clinical Trial Participation as an Investigator
CRF Fill-Up + QC (Quality Control) /QA (Quality Assurance) Activities
Statistical Analysis and CSR (Case Study Report) Writing