MichaelIbara
Services

Consulting, leadership and investor support.

How I work (backed by the operating record on the About page).

01

Consulting in clinical research operations and technology, pharmacovigilance and AI

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

Clinical operations, clinical research technology, and clinical data and informatics, backed by years of building and using systems in clinical research. Pharmacovigilance across the whole function: case processing, safety systems, signal detection and aggregate reporting. Analysis and appropriate application of AI across all stages of clinical research, from initial assessment to building a working prototype.

ClinOps LABFor clinical research leadership teams: an embedded program to decide where AI should go first. Ideas are gathered from staff, added to from outside experience, and evaluated with senior leadership for value and risk, with prototypes built where they help the decision. Formats: one day (general recommendations), one week (the top handful of ideas, no development), one month (the full program), or a quick demo of a chosen idea.
PV LABFor pharmacovigilance professionals and departments: assess where AI works best in your operations, from simple to complex applications that improve compliance, automate work and assist individuals, with the risks and mitigations of each. From one day to one month. Example outputs: an overview of the field, workflow designs with human-in-the-loop controls, a short internal playbook and a 90-day roadmap.
02

Fractional and interim leadership

Boards, CEOs, leadership teams

Chief data officer, chief strategy officer and vice president seats held, with experience across large global pharma, a large global CRO, an integrated research and site organization, an AI clinical technology startup and a clinical standards organization. Years at senior levels in large global pharma, working with regulators worldwide and managing vendors. Fractional, project-scoped or full-time, for a defined period or longer.

Functions covered: data science, pharmacovigilance, clinical operations, informatics and data products, AI programs. Hiring, vendor and roadmap decisions made from inside the organization.

Situations

  • Standing up, expanding or revitalizing research operations at site networks and care-delivery organizations
  • Scaling operations and creating value from applying AI and data
  • A leadership gap: a startup that needs a senior leader for a function, or an organization between leaders

Engagement shapes

  • Fractional: set days each week or month, with a seat on the leadership team
  • Project-scoped: a defined deliverable with a start and an end
  • Full-time: interim or permanent
03

Investor and private equity support

Private equity firms, investors, portfolio companies

Clinical research and AI expertise for deal teams, before and after close.

Before close

  • Diligence on a target's AI claims
  • Technology and data diligence
  • Pharmacovigilance and compliance diligence
  • Clinical research operations diligence

After close

  • Operating and AI readiness assessment of a portfolio company's clinical research function
  • AI value creation with ClinOps LAB or PV LAB
  • Strategic roadmaps for clinical operations and for AI in clinical operations
  • Building clinical research, data science or pharmacovigilance capability, including site networks
  • Vendor and technology selection
  • Interim leadership in portfolio companies

Throughout: advisory to deal teams and operating partners.

Built on operating and advisory work: a data science division at an integrated research and site organization, with direct integration to more than 40 electronic health record systems, and diligence for an investor on technologies for clinical site networks.

Also available: advisory board seats, speaking, expert-network consultation, expert witness work and training.

Start with a conversation. The first call is for scoping; a proposal follows if there is a fit.

Contact