DSMB
CVASS DSMB Services is your trusted partner in the pharmaceutical, healthcare, and clinical research sectors, specializing in comprehensive Data and Safety Monitoring Board (DSMB) services. With a team of experienced professionals and a deep understanding of clinical trial safety, we empower organizations to ensure the welfare of trial participants and the integrity of trial data.
Our Services
- DSMB Establishment: Assist in the establishment of independent DSMBs or provide DSMB services for ongoing trials.
- DSMB Charter Development: Develop DSMB charters outlining roles, responsibilities, and operational procedures.
- Safety Data Review: Monitor and review safety data to assess participant safety throughout the trial.
- Data and Endpoint Review: Evaluate trial data and study endpoints to ensure validity and integrity.
- Data Coding and Standardization: Apply standardized coding systems (e.g., MedDRA, WHO Drug) for consistent data reporting.
- Interim Analyses: Conduct interim analyses to assess trial progress and safety outcomes.
- Recommendations and Reporting: Provide recommendations based on safety and data reviews and prepare DSMB reports.
- Unblinding Procedures: Establish procedures for unblinding, if necessary, while maintaining trial integrity.
- Safety Oversight: Ensure compliance with safety reporting requirements and regulatory standards.
- Adverse Event Assessment: Assess adverse events and their impact on trial participants and outcomes.
- Confidentiality and Independence: Maintain strict confidentiality and independence in DSMB operations.
- Regulatory Compliance: Ensure DSMB operations align with regulatory guidelines and GCP (Good Clinical Practice) principles.
- Expert Consultation: Provide expert consultation to sponsors, investigators, and regulatory authorities.