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SINUAClinical Development

Governance that keeps the program in your hands.

We sit on the sponsor's side of the table. Our work is organized around the decisions you need to make and the partners you need to hold accountable.

The Governance Line.

One view of the program: phases, sponsor decision points, a continuous oversight cadence for CROs and vendors, and the risk signals watched in each phase.

Clinical program governance lineFour program phases, Plan, Start-up, Conduct and Close-out, each with a sponsor decision point, under a continuous CRO and vendor oversight cadence with risk signals monitored in every phase.PlanPHASE 01DECISIONFEASIBILITYBUDGET ASSUMPTIONSStart-upPHASE 02DECISIONACTIVATION DELAYSVENDOR READINESSConductPHASE 03DECISIONENROLLMENTDATA QUALITYVENDOR PERFORMANCEClose-outPHASE 04DECISIONTIMELINEDOCUMENTATIONCRO AND VENDOR OVERSIGHT CADENCE

  1. Plan

    Decision: Program and outsourcing decision

    Risk signals: Feasibility, Budget assumptions

  2. Start-up

    Decision: Readiness for first participant

    Risk signals: Activation delays, Vendor readiness

  3. Conduct

    Decision: Course corrections and interim decisions

    Risk signals: Enrollment, Data quality, Vendor performance

  4. Close-out

    Decision: Database lock and close-out

    Risk signals: Timeline, Documentation

Program path Sponsor decision point Oversight cadence Risk signal

Sponsor-side activities

  • Enrollment and data quality tracking
  • Governance meetings with CRO and vendors
  • Risk indicators and issue escalation

Decision point

  • Course corrections and interim decisions

Oversight and risk signals

  • KPI review and escalation
  • Enrollment
  • Data quality
  • Vendor performance

Five principles.

  • Sponsor-side perspective

    We represent the sponsor's interests in every discussion with CROs and vendors, and we are paid only by the sponsor.

  • Governance

    Defined decision points, roles and escalation paths, agreed before they are needed.

  • Operational discipline

    Plans, trackers and logs kept current, so status is a fact rather than an impression.

  • Accountability

    Every commitment has a named owner. We report what we see, early and plainly, including when it is unwelcome.

  • Collaborative working model

    We work inside your team and alongside your partners, strengthening your organization rather than replacing it.

How an engagement begins.

  1. Listen

    A confidential first conversation about your program, your team and the decisions ahead.

  2. Assess

    A focused review of plans, contracts and current status to identify gaps and priorities.

  3. Agree scope

    A written proposal with defined scope, deliverables, ways of working and reporting.

  4. Lead and report

    Hands-on support with regular, candid reporting to your leadership.

Discuss your program