Building strong outsourcing partnerships with Clinical Trial Governance & Vendor Oversight

We help you through the complex but critical process of building and implementing a fit-for-purpose governance and oversight structure that lays the foundation for the success of your long-term strategic sponsor-supplier relationship.

Benefits of governance and oversight

With our solution, you’ll get:

Our final highly data-driven decisions will meet your business needs and will serve as a strong basis for the conduct and delivery of outsourced trials.

Our fit-for-purpose solutions and a set of standardized processes will help you to maintain quality and compliance in your outsourcing models.

After passing our Mock Audit process, you will be 100% ready for a real one.

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After selecting your CRO or vendor, set the foundation for your long-term strategic sponsor-supplier relationship with clear expectations, structure, and responsibilities.

We guide you through the complex but critical process of implementing manageable and executable governance and oversight structures to get the results you agreed to while maintaining open and stable relationships with your vendors.

What to expect

We thoroughly assess what is needed and what is already available (either from the sponsor or CRO team) to equip you with an oversight toolkit and governance model for the senior sponsor-supplier core team.

Risk-Based Approach

Micro-management vs Oversight

Expectation Management

Target Limited Resources Better

Seuss+ Clinical Trial Governance & Vendor Oversight Process

Step 1

Vendor Management

Implement the tools for effective vendor management and oversight, ensure quality & compliance, and create a common understanding of the objectives, timelines, and risk mitigation plans.

Step 2

Mock Audit

The best way to ensure you are ready for an audit is by performing one. We work with independent QA experts to uncover potential gaps in compliance.

Step 3

Performance Management

We help you create a detailed plan of action, with clearly defined KPIs and SOPs, fully oversight documentation, communication plans and tools for escalation.

Step 4

Governance & Oversight

From committee mapping and roles and responsibilities to the most effective meeting structures and agendas, together we build a detailed governance plan.

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Vendor oversight is required by ICH-GCP to ensure sponsor accountability

We work with you to integrate specific suppliers into your general governance structure and keep oversight of everything.

Compliance

Co-monitoring
Internal Quality Checks (training record, TMF, data reviews, etc.)
Audits
Issue Log

Performance

Key Performance Indicators
Quarterly status update report

Relationship

Contract (MSA)
Work Orders
Out of Scopes
Update meetings
Informal calls

Risk Management

Supplier Classification
Risk Log

Rules (process)

Governance Meeting Structure
Roles and Responsibilities
SOPs
Supplier Oversight Plan
Filing Structure

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