BioStrategics Consulting Ltd offers the following clinical development consulting services to pharmaceutical, biotechnology, and medical device companies:

• Clinical program strategy and planning
• IND and first-in-man trial planning
• Clinical protocol conceptualization and creation
• Identification of, and interaction with, prospective investigators and academic thought-leaders
• Contract Research Organization evaluation, selection, liaison, and management
• Trial oversight and Medical Monitoring
• Data analysis, interpretation, and presentation
• Preparation of requisite clinical documentation for regulatory submissions
• Contribution to regulatory strategies
• Participation in regulatory authority meetings and related interactions
• Participation in multidisciplinary drug development teams
• Organization and management of expert panel and advisory group meetings
• Scientific and technical evaluation of new projects
• Due diligence for in-license candidates
• Business development, fund-raising, and partnering efforts