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SINUAClinical Development

Sponsor-side clinical development & operations consulting

Your clinical development. Strategically managed.

We work on the sponsor's side of the table, helping pharmaceutical and biotechnology teams plan development, lead clinical projects and oversee CROs and vendors.

Discuss your programExplore our expertise

You can outsource execution. Not accountability.

When work is delegated to CROs and vendors, the sponsor still owns every outcome. We help you keep that ownership informed and in control.

Every partner, accountable to your program.

Defined decision points, clear governance and candid reporting keep CROs and vendors aligned with your development objectives.

Decisions made with evidence and visible risk.

Strategy connected to operations, so your team can decide earlier and with confidence.

Discuss your program

Built for sponsors who carry the accountability.

Many clinical programs are run by lean teams that outsource execution but cannot outsource responsibility. We bring senior, sponsor-side judgment to the plans, partners and decisions that shape your program.

  • Emerging biotechnology companies
  • Clinical-stage biotechs
  • Small and mid-sized pharmaceutical companies
  • Teams building or stretching their clinical operations
  • Sponsors that need CRO management and project leadership
Translucent sheets stacked like protocol pages, with a fine lavender line of light passing through them

Services

Four ways we support your clinical program.

Each service is anchored to the point in the program where it acts.

Our approach

Governance that follows the whole program.

Select a phase to see where the sponsor decides, what we oversee and which risk signals we watch.

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

How we work

What makes SINUA different.

Sponsor-centered perspective

We work only for the sponsor. Our judgment is shaped by your development objectives and decisions, not by a vendor's scope of work.

Strategy connected to execution

We translate development strategy into operational plans, and bring operational reality back into strategic decisions.

Senior-level expertise

Every engagement is delivered by specialists with 20 or more years of experience in their own field, from development strategy to quality assurance.

Accountable, transparent collaboration

Clear ownership, early risk identification and plain reporting. You always know where the program stands and why.

Our team

Senior specialists in every function.

Good clinical development depends less on activity than on judgment: knowing which questions to ask, when to escalate and how to keep every partner honest about where the program stands.

Every engagement is delivered by specialists with 20 or more years of experience in their own field, from development strategy to quality assurance.

  • Development Strategy: PhD in Pharmacy, 25 years
  • Project Management: Bachelor of Pharmacy, 20 years
  • Biostatistics: Master's degree in Statistics, 20 years
  • Medical Writing: Physician, 30 years
  • Quality Assurance: Globally certified auditor, 28 years

Experience shown is each specialist's individual professional experience.

Meet our specialists

Insights in preparation.

Practical perspectives on the questions sponsors face. Our first articles are being written now.

Start with a confidential conversation.

Tell us where your program stands and the decisions ahead. We will tell you plainly whether and how we can help.

Discuss your program