Medical Safety & Quality Assurance

Data monitoring committee (DMC) or data and safety monitoring board (DSMB) adds to the objectivity and credibility of clinical trials and serves the independent certification on issues such as adjudication of efficacy endpoints, conduct of planned interim analyses, and safety monitoring.

Symyoo serves to organize and coordinate the committee with qualified members, including physicians, biostatisticians, clinical operations representatives, data manager, and/or safety surveillance experts.

Symyoo QA team organizes the internal team trainings to be compliant with ICH-GCP, ISO14155 and other applicable regulations/guidelines. The QA activities support the successful delivery of Symyoo's quality clinical operation and outcomes.

Symyoo QA team also provides guidance, training and key input to clinical study teams for consultation and interpretation of regulations, guidelines, internal SOPs and policies


 

Medical Safety and Adjudication

• Medical Safety Management
• Independent DMC/DSMB Charter Service and Committee Composition
• DMC/DSMB Meeting Coordination
• Central Data & Safety Adjudicator Designation and Adjudication Process Coordination

Clinical Quality Assurance Services

• Process and Risk Assessments
• Standard Operation Procedures (SOPs) and Guideline Management
• Internal Team Training Management: Newcomer/ Basic/ Advanced Training Courses
• Development of Corrective and Preventive Actions (CAPA)
• Regulatory Compliance Management
• Internal Audit and Monitoring QC Visit
• Sponsor/ External Audit Preparation
• Regualtory Agency Inspection Preparation
• Vendor Assessment Audit