Bio Soft Research provides comprehensive clinical trial monitoring and management that includes BA/BE. All monitoring activities are conducted in accordance with ICH GCP guidelines and applicable regulatory guidelines. Bio Soft Research develops a Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.

Clinical site monitoring services include:

• Site identification
• Site initiation
• Budget and contract negotiation
• Regulatory document preparation and collection
• Investigator meeting planning and presentation
• Site personnel training
• Interim site monitoring visits
• Clinical study material accountability
• Site closure