Clinical Trial Governance & Vendor Oversight
Creating, implementing and executing structures to identify risks, ensure compliance, and escalate issues.
Building strong outsourcing partnerships
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.
Create executable governance and oversight structures across your vendors, improving the manageability, flow of information, and protocol changes.
Clear Decision Making
Adopt standardized processes and custom plans that allow you to cut down on time spent in meetings, making better-informed decisions more quickly.
We give you the tools to implement high-quality standards across your vendors, keeping you ICH GCP E6 (R2) compliant and prepared for a surprise audit.
Prepare for inspection-readiness
We will drive and document the various levels of governance and clinical trial oversight, ensuring the plans are carried through from kick-off to approval.
Adapting these fit-for-purpose solutions and a set of standardized processes will help you to maintain quality and compliance in your outsourcing models.
What to expect
We take a thorough approach to 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.
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.
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.
We help you create a detailed plan of action, with clearly defined KPIs and SOPs, fully oversight documentation, communication plans and tools for escalation.
Governance & Oversight
From committee mapping and roles and responsibilities to the most effective meeting structures and agendas, together we build a detailed governance plan.
Client impact and sharing experiences.
What others say
“This organized, dedicated and enthusiastic team go the extra mile to guide you to a final highly data driven decision, which meets your business needs and serves as a strong basis for the conduct and delivery of outsourced trials.″
I’m Nicolyn, Senior Business Consultant at Seuss+
I’d like to get to know you and your business. I am ready to answer your questions and start tackling your business challenges.
Webinar Replay: prevent problems and mitigate risks with the CAPA process
Watch the free webinar replay and discover how the CAPA process helps you to prevent problems and mitigate risks in your life science business.