CRO Management & Vendor Management

  • Compliance with ICH-GCP E6 (R2)
  • Integrated Shared Governance

In compliance with the ICH-GCP E6 (R2) guideline, we jointly develop and implement an active and efficient CRO management/vendor management plan for conducting your clinical trial. Optimized interaction between sponsors, CROs and vendors by mastering different corporate cultures, expectations and efforts will advance your company to the next development stage.

Efficiently reduce your risks

Aligned teams

Common understanding of content, objectives and timelines

Optimized decision-making

Save time and avoid micromanagement

Compliance with ICH-GCP E6 (R2)

Active and efficient risk-based plan to manage CRO and vendors

Shared governance

Cooperative monitoring and performance evaluation of CRO/vendors

What we can do for you

Risk-based CRO/vendor management plan

  • Definition of risks
  • Implementation of risk mitigation strategies and early warning systems

Active performance evaluation

Standardized communication

  • Implementation of a shared governance model
  • Agreement on expectations to optimize the partnership
  • Development of a joint vision for a successful study performance 

Not sure what a specific regulation says or want to know more about the meaning behind a certain term? Visit our glossary.

Our expertise, your benefits

We have successfully implemented CRO/vendor management concepts and tools in close cooperation with our customers. You benefit from our expertise from working with sponsors and CROs/vendors and our deep understanding of processes and workflows.

Contact our experts to find out more!

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We look forward to assisting you in making your vendor your partner!

Dr. Christiane Juhls

Project Director Lumis Life Science Consulting GmbH

Phone: +49 30 235911-599

info@lumisconsult.com

We look forward to helping you find your best fit in outsourcing your clinical trials!

More about CRO/vendor management in Lumis’ Content Hub

Sponsor-vendor relationship – it takes two to tango (at least) CRO Management
- The number of small Biopharmaceutical and Medical Device Companies (“small sponsor companies”) conducting early stage clinical trials is increasing. Outsourcing and vendor management are essential for survival of these companies, since they are usually facing the challenges of limited budgets and resources.

Sponsor-vendor relationship – it takes two to tango (at least) Read More