Service Providers
Service Providers
- Name of Company
- 비바시스템즈코리아
- Address
- 서울특별시 강남구 테헤란로 87길 36, 19층
- Key Services
-
- Clinical Solution
- Consulting
- Decentralized Clinical Trial(DCT)
- Homepage(English)
- https://www.veeva.com/kr/
- Sales(end of 2024)
- NR
- Human Resources Status
- NR
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- NR
- ISO 9001
- Provided
- Status of Additional Certifications
- ISO/IEC 27001:2013, ISO/IEC 27017, ISO/IEC 27018, SOC 2 Type II, ISO 14001
- Key Strengths
-
Veeva는 Vault Clinical Suite를 통해 EDC, CTMS, eTMF를 통합하며 임상 운영 효율을 극대화합니다. 특히 DCT(분산형 임상시험)에 최적화된 환자 중심 디지털 환경과 원격 협업 솔루션으로 물리적 제약 없는 유연한 임상을 지원합니다. 나아가 Safety, RIM(허가 정보 관리) 솔루션과 임상 데이터를 단일 플랫폼에서 실시간 연계함으로써, 데이터 생성부터 허가 및 안전성 보고에 이르는 전 과정을 통합 관리합니다. 이러한 솔루션 간 유기적 협업은 유연한 임상 운영과 글로벌 규제 준수와 빠른 의사결정 실현을 지원합니다.
- Introduction Materials (Upload attachment)
-
-
Clinical Solution Services
- Biostatistics
- Provided
- eCRF
- Provided
- E-Consent
- Provided
- ePRO/eCOA
- Provided
- EDC
- Provided
- CTMS
- Provided
- eSafety
- Provided
- IWRS
- Provided
- e-TMF
- Provided
- Virtual Data Monitoring
- Provided
- Other
DCT Services (Decentralized Clinical Trials)
- Online Subject Recruitment
- Not Provided
- E-Consent
- Provided
- IP (Investigational Product) Delivery
- Not Provided
- Remote Study (Remote Monitoring & Telemedicine)
- Not Provided
- In-home Research (Home Visits to the Subject’s Residence for Specimen Collection Including Blood Collection and Vital Sign Assessment)
- Not Provided
- Off-site Data Collection – Self-Collection of Specimens (e.g., Personal Diagnostic Kits)
- Not Provided
- Off-site Data Collection – Self-Measured Health Data (e.g., Personal Health Management Products, Wearable Devices, Medication Adherence Tools)
- Not Provided
- Cardiovascular Disease (CVD)
- Not Provided
- Diabetes / Endocrine Disorders
- Not Provided
- Respiratory Diseases
- Not Provided
- Sleep Disorders / Sleep Apnea
- Not Provided
- Obesity / Metabolic Syndrome
- Not Provided
- Medication Management (Electronic Pill Bottle, Recording Medication Intake, etc.)
- Not Provided
- Off-site data collection – self-report(ePRO/eCOA)
- Provided
- Remote Data Monitoring
- Provided
- Other
Consulting Services
- Consulting
- Provided
Compliance Certification Status for Domestic and International Data Protection Regulations
- Data Protection Regulation_GDPR
- Provided
- Data Protection Regulation_21CFR11
- Provided
- Data Protection Regulation_others
- EU Annex 11