Clinical Development Consulting

ICON offers global, robust clinical development consulting to virtual companies, start-ups, biotechs, pharmaceutical, and medical device sponsors. The ICS team supports the full life cycle of a compound, small molecule, biologic, biosimilar, or device from entry into clinical development through product launch and into late phase.  Based in the US and EU, ICON experts support clients across all times zones.

Services Summary

  • Preparation of Product Development Plans
  • Protocol development assistance: consultation on study designs, endpoints, objectives, measurements and statistical analyses
  • Scientific and medical oversight of on-going trials
  • Patient recruitment and retention strategies
  • Strategies to maximize Critical Path Development and minimize time-to-market
    • Recruitment strategies
    • Feasibility assessments
    • Use of imaging, biomarkers
  • Full lifecycle support, including clinical, regulatory and Chemistry, Manufacturing and Controls (CMC) strategies
  • Innovative solutions to optimize efficiency, such as adaptive design, operational adaptions: enrollment, data quality and enrichment designs
  • Liaison with KOLs and collaborative groups
  • Investigator/sponsor relationships
  • Development of Academic Advisory Boards
  • Plan and prepare development teams for  interaction and negotiation with regulatory agencies regarding regulatory, CMC, clinical and toxicology matters, and development of  pre-meeting packages
  • Due diligence for individual disciplines and/or across disciplines for asset assessment to support acquisitions, etc.
  • Ad-hoc consulting
  • Short to mid-term dedicated client support
  • Provision of an integrated package of clinical expertise
  • Therapeutic area and protocol training
  • Project strategy oversight
  • Assistance with scientific publishing

Why work with ICON Consulting Experts?

  • We understand your strategic vision, working as an extension of your internal team, serving as your trusted partner.
  • Gain a deeper understanding of development options, with respect to scientific and regulatory risks, costs and timelines, to meet overall business objectives.
  • Address cross functional questions and understand the impact of gaps.
  • Gain access to in-depth scientific expertise across disciplines for ad hoc support