Dt&CRO

Regulatory Affairs / Consulting

- Regulatory and Market Access Strategies
- Product Registrations
- Regulatory Dossier Writing (CTD Packaging and CTD Writing)
- Gap Analysis
- Orphan Drug Designation
- CE Registration (MDR, based on ISO14155)

Medical Affairs

- Synopsis, Protocol Writing
- CSR Writing
- Clinical development consulting
- Medical monitoring for clinical trial
- Medical Consulting

Clinical Operation

- Specialized focus on tasks by dividing Teams
- Site and Investigator Feasibility
- IRB Affairs
- Study and Site Monitoring (Start up/PSV,SIV,SMV,COV)
- Unblind Part Operation
- Risk Based Monitoring

Data Management

- Data Management
- Design/Development of CRFs
- EDC Set-up (Medidata, CRScube, SafeSoft)
- Medical Coding (Certified MedDRA Coder)
- SAE Reconciliation
- External Data Handling
- Data Quality Control
- Data Matrix
- Dedicated DM
- CDISC (Clinical Data Interchange Standards Consortium)
- SDTM(Study Data Tabulation Model)

Biostatistics

- Statistical Consulting and Design
- SAP, SAR (Statistical Analysis Plan, Result) writing
- Sample Size Calculation
- Randomization & IP Management
- Interim and Final Statistical Analysis
- Additional Statistical Analysis (TLG generation)
- CDISC-ADaM(Analysis Data Model)

Quality Assurance

- Quality Management System/Consulting
- GCP/PV Audit
- Project Audit
- GCP SOP Development
- Clinical Trial Training

Pharmacovigilance

- Medical Assessment of Adverse Events
- Operation and Management of DSMB, IDMC, SRC
- DSUR, PBRER, PSUR, RMP
- Maintenance of Safety Databases(ARGUS, cubeSafety)
- Reporting of ICSR, SUSAR
- PV SOP Development and Training