Risk Management for Double-Blind Clinical Trial Supplies

Risk Management, Mitigation Management

Risk Assessment, Hazard Analysis, Facilitation, Design Revision Input

To evaluate the effectiveness of medicinal drug and procedures, it is important that clinical trial results are not influenced by the expectations of the people involved, branding, or other properties not being tested.

Double-blind trials are often used to minimise participant bias and observer bias, and makes the results more reliable.

Bias may be intentional or unconscious. For example, where a person might have a prior interest or belief that one treatment is better than another.

Cambridge Medtech Solutions facilitated the risk management and mitigation management activities of supplies used in a clinical trial. Risk management covered both patient safety risks (to ISO 14971) and general project risks. Mitigation management encompassed design revision input, manufacturing and inspection.

“I appreciate the way you engaged in the risk work, especially in the run-up to the project milestones when activity was intense … you demonstrated high engagement, day and night.”