Services Offered
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