Quality Assurance

Quality Assurance

Quality Assurance procedures are essential processes and crucial ways of working at Bones Medical. Our comprehensive Standard Operating Procedures guide and train staff, as well as ensuring that operations are carried out in compliance with applicable standards (e.g., ICH-GCP, ISO 14155, ISO 20916, etc.) and according to our sponsors’ requests and requirements.

Bones Medical ensures the right quality

The following areas are covered by our quality management system, which guarantees the excellent quality of work delivered by Bones Medical:

• Staff and training
• Risk mitigation
• The internal safety measures
• Examining and evaluating
• Processes for creating SOPs and policies
• Evaluation and management of vendors
• Handling of incidents, including corrective and preventive measures (CAPA)

Advanced Analytics

Bones Medical leverages historical data across hundreds of trials to model predictive scenarios and categorize risk by severity of impact. AI techniques complement clinical development and therapeutic knowledge to offer an unprecedented level of sensitivity when characterizing trends of importance or potential compliance issues.