MichaelIbara
Michael Ibara, Pharm.D.

An AI‑native domain expert in clinical research and pharmacovigilance.

20+ years in clinical research and pharmacovigilance, and daily hands‑on work using and building AI on real clinical problems.

Pharm.D.University of MichiganFellowship in Clinical Drug Research and Development, University of North Carolina and Burroughs Wellcome
20+ yearsclinical research and pharmacovigilance at global scale
Hands‑on AIproducts built to solve real clinical problems
CDO, CSO, VPchief data officer, chief strategy officer and VP seats held at three organizations
Large global pharma Large global CRO Biotechnology Integrated research and site organization Clinical standards organization AI clinical technology startup FDA, EMA and national regulators
Areas of expertise

Broad experience across drug development.

Clinical operations

Ran trials hands‑on at a large global CRO; implemented technology globally at a large multinational biopharma company; led clinical operations at a biotechnology company; built AI products that clinical operations and site teams use.

Data and technology

Designed informatics solutions for integrating healthcare and research data; built a data science division at an integrated research and site organization, with direct integration to more than 40 electronic health record systems.

Applied AI

AI products built with a development team at an AI clinical technology startup, including ProtocolCopilot; an agentic design for scalable informed consent; an AI safety training program for an executive team; a product rebuilt alone in a week with current models.

Pharmacovigilance

Built pharmacovigilance functions at a large global CRO and a biotechnology company; 15 years in safety at a large global pharma; conceived and led ASTER - the first-ever study to automatically capture adverse events from the EHR and send to FDA.

Services

Who I work with.

Investors and private equity

Before close, diligence on clinical research and AI technologies; after close, strategic roadmaps for clinical operations, for applying AI to them, and for building clinical site capability.

Investor support

Sponsors, CROs, site networks, research sites and health technology companies

Consulting and leadership in clinical research operations and technology, pharmacovigilance and AI, including ClinOps LAB and PV LAB: distinguishing what is feasible and valuable from what creates technical debt or compliance risks.

Consulting and leadership

Boards and leadership teams

Fractional and interim leadership. I have held chief data officer, chief strategy officer and vice president seats and am able to fill one on an interim, fractional or permanent basis.

Fractional and interim
Services Background Work with me