Strategic CRO Oversight—Without the Headcount

You outsourced to a global CRO for their scale and reach. But who's ensuring they deliver on time, on budget, and to GCP standards? We provide senior-level oversight and active vendor management—so your trial doesn't get lost in their portfolio while you stay in control without building a large internal team.

 
Let’s run your trial, together.

Three Core Pillars of Effective Sponsor Oversight

Strategic CRO Selection & Contract Setup

We help you choose the right CRO based on fit, not just size. Together we define selection criteria, evaluate proposals, negotiate scope, and align deliverables to your budget and operational needs.

Active Oversight & Performance Management

We build and implement your oversight plan: KPIs, escalation paths, reporting cadence, and risk controls. Then we track timelines, monitor quality, flag issues early, and manage vendor accountability—so you don't have to chase updates.

Issue Handling & Sponsor-Level Visibility

We don't just surface problems—we intervene and resolve them. Timeline slips, eTMF gaps, deviation patterns, or quality concerns get documented, escalated, and corrected. Your sponsor oversight file stays inspection-ready throughout.

Strategic CRO Selection & Contract Setup

We help you choose the right CRO based on fit, not just size. Together we define selection criteria, evaluate proposals, negotiate scope, and align deliverables to your budget and operational needs.

Active Oversight & Performance Management

We build and implement your oversight plan: KPIs, escalation paths, reporting cadence, and risk controls. Then we track timelines, monitor quality, flag issues early, and manage vendor accountability—so you don't have to chase updates.

Issue Resolution & Regulatory Documentation

We don't just surface problems—we intervene and resolve them. Timeline slips, eTMF gaps, deviation patterns, or quality concerns get documented, escalated, and corrected. Your sponsor oversight file stays inspection-ready throughout.

How We Work

  • 01Define

    Build oversight framework, set KPIs, establish decision criteria

  • 02Monitor

    Track CRO deliverables, timelines, budgets, and quality metrics

  • 03Intervene

    Proactive issue detection and resolution before risks escalate

  • 04Document

    Support you in maintaining inspection-ready sponsor oversight file

Why Sponsors Choose Us

Senior PM Expertise

Experienced Clinical Operations professionals who understand both sponsor and CRO perspectives

CRO Accountability

We know how large CROs operate—and how to hold them to commitments

Lean Model

Focused oversight expertise without full-time headcount costs

Regulatory Documentation

Documentation that withstands inspection scrutiny

Compliance and Standards

ICH E6(R3) Compliant Oversight

Full sponsor responsibilities covered per updated GCP guidelines

Vendor Management Expertise

Proven track record managing CROs, labs, and other service providers

CAPA Focus

Real corrective actions, not just documentation for compliance sake

Strategic Oversight—Lean Execution

What you gain without growing your team 

  • Objective vendor management with senior-level expertise on demand 
  • Active coordination between CRO, sites, and further service providers 
  • Proactive risk detection before issues become regulatory findings 
  • Clear visibility into timelines, costs, quality metrics, and progress 
  • Real-time issue resolution with documented escalation and follow-through 
  • Regulatory confidence through compliant sponsor oversight documentation 

The result: Control and visibility over your outsourced trial—without the resource burden of building an internal Clinical Operations team. 

Ready for strategic oversight without the headcount?

Let's discuss your trial scope and show you how we ensure CRO accountability while keeping your sponsor responsibilities compliant and manageable. 

Call Dr. Doris Greiling directly on +49 (0) 1520 921 96 49 or write us an email. 

Doris Greiling
+49 (0) 1520 921 96 49
info@forschungsdock.de

Schedule a Consultation

Ready for strategic oversight without the headcount?

Let's discuss your trial scope and show you how we ensure CRO accountability while keeping your sponsor responsibilities compliant and manageable. 

Call Dr. Doris Greiling directly on +49 (0) 1520 921 96 49 or write us an email. 

Schedule a Consultation