Oversight Management for Clinical Trials

  • Optimised performance
  • Proactive management
  • Budget control

The experts at Lumis Life Science Consulting support your clinical team in implementing and maintaining an oversight management system. We jointly define and integrate an effective and risk-based study oversight plan to manage the quality, patient safety and data integrity during the different stages of your clinical trial.

Be on top of the process

Comply with ICH-GCP E6 (R2)

Manage your trial performance according to regulations

Manage quality proactively

Timely perform corrective and preventive actions

Keep control over budget

Avoid surprising results with high financial impact

Comply with turnaround-time

Prevent delay by implementing effective tools, KPIs, resource planning

What we can do for you

Clinical trial oversight management plan

  • Tailored to your needs
  • Study-specific and risk-based
  • Compliant with ICH-GCP E6 (R2)

CRO/vendor management

  • Shared governance model
  • Transparent communication involving all levels of the study team

Implementation of oversight tools and KPIs

  • Fast and convenient monitoring according to high quality standards and patient safety
  • Tailored KPI reporting system

Knowledge transfer and training of team

  • We coach your teams for effective risk-based oversight

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

Your Lumis Life Science Consulting team understands the needs and challenges small and mid-sized companies face while developing an oversight management system. You will benefit from our deep understanding and risk awareness, and our high competence in selecting and implementing the appropriate oversight tools.

Contact our experts to find out more!

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    We look forward to helping you in oversight management for your clinical trial!

    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 oversight management for clinical trials in Lumis’ Content Hub

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