BioStrategics Services

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

Copyright © 2011 BioStrategics Consulting Ltd.


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