Webinar
Ensuring a successful regulatory inspection with support from your IRT provider
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March 18, 2025

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11:00am - 1:00pm

(GMT-04:00)

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Regulatory Inspections are cumbersome, require a lot of time and energy. Fast paced and short timelines put pressure on even the most talented subject matter experts. Knowing you work with an IRT vendor that can provide fast, adequate support can help alleviate some of the inspection burden.

Join us as we discuss five key areas of preparation and regulatory focus based current industry trends:

  • Audit trail. Audit trails help inspectors review the history of data, allow the study to be recreated, and identify signs of anomalies such as data manipulation or abnormal data. Understand how compliance with EMA/INS/GCP/112288/2023 will help ensure you are prepared for a smooth inspection.
  • Data Integrity. Go beyond buzz words such as ALCOA++ with a plan to demonstrate accuracy, consistency, and completeness of data throughout the lifecycle of the trial.
  • Transparency and defined ownership of activities. Knowing who is responsible for what saves a lot of time when you need to obtain evidence quickly.
  • Randomization. After all, it is a key feature of an IRT delivery. Adequate care for blinded trials should be considered. Procedures for randomization should be readily available. Randomization assignments should be able to be shared.
  • User Access Management. Define how is system access controlled, and data integrity ensured

Justine Koor

Director, Quality Assurance, Digital Products & Solutions, IQVIA, Certified Information Privacy Manager (CIPM) IQVIA

Justine Koor joined Cenduit/IQVIA in 2008 and has been a part of IQVIA and the IQVIA IRT leadership team since 2013. Koor is a quality professional with over 20 years of experience in computerized systems validation and auditing, and quality systems management. With a career start in operations prior to moving to quality, she understands the day-to-day efforts and what quality can bring to operations teams. She demonstrates her experience with regulatory inspections and inspection responses and by supporting sponsors complete successful regulatory inspections related to IRT and computer systems.
Additionally, Koor is responsible for the operational activities of the quality assurance department and the development and maintenance of all aspects of the quality system.

She is a data protection champion and is CIPM certified. Koor is dedicated to supporting teams identify and implement data protection laws into everyday practices. Koor is based in Basel, Switzerland.

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