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Inspection Preparedness after CRO Transfer

The study is closed and your CRO is getting ready to transfer your study. You want to ensure this invaluable data is handled properly, so as to not break the audit trail. Maximize the chances of a successful inspection by planning ahead, collaborating with your CRO, and handling your data correctly.

This webinar will cover:

  • How to prepare for inspection
  • What you might need from your CRO before and after TMF transfer
  • Inspection logistics / what to expect
  • What to do with your data after inspection

Join SVP of Clinical Operations, Marion Mays, and Kivo's CEO Toban Zolman to improve your inspection preparation plan.

Date: June 8th, 2023

Time: 10am PST (1pm EST)

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About the Presenters

Marion Mays brings extensive experience in Inspection Readiness and supports clients in their efforts to become fully inspection-prepared. Marion is a dynamic, inspirational leader in the Life Sciences space with over 30 years of experience. Offering a unique combination of both strategic and operational abilities she also has in-depth experience with quality and compliance processes in the pharmaceutical industry with focus on supporting organizations through GCP regulatory inspections with FDA, MHRA, EMA, and PMDA. Her experience working for sponsors, CROs, software vendors and directly helping sponsors manage inspections make Marion uniquely positioned to offer valuable insights into this process.

 

Toban Zolman has extensive experience solving complex business challenges using software. Toban was an early employee at Regulatory software pioneer ISI, helping shape the transition to electronic submissions. He has worked with dozens of the largest global pharmaceutical companies to define business processes around clinical and regulatory processes. Toban is CEO of Kivo, a software provider focused on streamlining the drug development process for emerging life science companies.

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eTMF Reference Model

Kivo organizes documents using the familiar eTMF reference model making it fast to learn and easy to train.

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Integrated Digital Signatures

Customizable Collaboration, Review, and Approval workflows with Part-11 Compliant Digital Signatures.

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Economical, straightforward pricing

Comprehensive pricing gives you access to every Kivo feature, and ongoing releases.

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Smart Document Placeholders

Reuse content, assign documents to users, and always have visibility into when content will be completed.

Clinical Document Management That Works Like You Do.

 

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