365bet平台代理_(中国)官方网站

  Pharmacovigilance:

• - Case Management in multiple languages (Chinese, English, Japanese, Korean)
• - Multi-language Safety Database  (Argus, ARISc, BioKnow etc.)
• - Signal Detection Tool (MedVal AI and Advera Health etc.)
• - Chinese and English Literature Search
• - Call Center
• - Aggregate report preparation: PSUR/PRBER, ASR, DSUR, etc.
• - Signal Detection, Evaluation and Risk Management
• - RMP/RCP Preparation
• - IDMC and SRC
• - Pharmacovigilance System Consulting and Training
• - Pharmacovigilance Audit
• - Post-marketing Drug Intensive Monitoring (DIM) Study
• - Safety Reference Information (IB, CCDS, Labeling etc.)
• - PV Staffing

Medical Monitoring:

• - Medical Monitoring Plan (MMP) and Medical Monitoring Report (MMR)
• - Protocol and Medical training
• - Medical support for clinical team
• - Subject Eligibility Review
• - Protocol Deviation Review
• - 24 hour/7 day Medical Support
• - Support Emergency Unblinding Process
• - Medical Query
• - Medical Review of Clinical Data
• - Data Clearing and Reconciliation
• - Participate SRC and IDMC

Medical Writing:

• - Bilingual Medical Writing
• - Target Product Profile
• - Clinical Development Plan
• - IND Document Compilation
• - Protocol Design and Writing
• - IB Writing and Updating
• - Preparation of ICF and CRF
• - Clinical Study Report
• - Meta-Analysis
• - Labeling
• - Publication
• - Translation

Phase I Study:

• – FIH Studies: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety and PK Studies
• – Bridging studies
• – PK-PD studies
• – Drug-food, Drug-Drug Interaction studies
• – Clinical testing for new formulations
• – Bioequivalence studies
• – Study design and protocol development
• – Project management, EC/IRB submission, CDE registration, Human Genetic Office submission
• – Data management, programming and statistics
• – Clinical monitoring
• – Clinical study report in Chinese or/and English
• – NMPA, FDA,EMA, and WHO regulatory affairs

EDETEK Integrated Platform

EDETEK eClinical is Digital Clinical Trial Orchestration Hub. Connecting eConsent, ePRO, IWRS, ePayment, patient devices, CTMS, EDC and other systems into one integrated ecosystem.

• - A single cloud-based platform of unified components support full spectrum of clinical study conduct, analysis, and submission
• - A single user-friendly interface for all functions
• - A hosted solution at an affordable price, eliminating the need for time-consuming and costly management and validation tasks
• - Integration to 3rd party applications and systems
• - Standard and metadata-driven for cross-study consistency and reuse
• - Real-time event management, monitoring, and analytics