Data Safety Monitoring Boards (DSMB) play an increasingly important role in the oversight of clinical trials. A DSMB's mandate is to ensure research participant safety and data integrity and avoid unnecessary research expenditure by providing early detection of overwhelming treatment efficacy or of futility by demonstrating statistically the treatment outcomes.

The ethica DSMB is comprised of a group of independent, national experts in biostatistics, clinical research, clinical pharmacology, medicine, epidemiology, and bioethics who monitor unblinded safety and efficacy data of your ongoing clinical trial.

ethica’s DSMB services include the following:

• Development of study-specific standard operating procedures ensuring compliance with the highest local and international normative standards
• Development of independent endpoints and statistical plan
• Independent data analysis and data reporting to the DSMB
• Comprehensive DSMB meeting reporting with properly justified decisions and recommendations.