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