How Inokura Strengthened Its Audit Readiness with ECCRT’s Training
Inokura successfully equipped its team with the knowledge and confidence to navigate audits and inspections seamlessly.
About Inokura
Inokura is a pharmaceutical research organization dedicated to advancing clinical drug development. Committed to excellence and regulatory compliance, Inokura partners with leading experts to ensure high-quality standards across its clinical trials. The company operates with a strong focus on data integrity and continuous improvement, ensuring the success of its research endeavors.
Challenges and Objectives
Inokura recognized the importance of being well-prepared for audits and inspections, they faced several challenges:
- A need to improve their understanding of regulatory expectations in clinical trial inspections.
- Ensuring seamless audit preparation, with a structured approach to documentation and compliance.
- Addressing common pitfalls in audits and inspections, including communication gaps and procedural inconsistencies.
Strengthening readiness for sponsor and CRO-led audits.
How ECCRT Helped
To tackle these challenges, ECCRT provided a one-day, expert-led training session focused on practical, real-world audit and inspection readiness.
What made the training valuable?
- Clear, structured modules on what happens during an inspection and how to prepare.
- Interactive workshops with real-world audit scenarios, so participants could practice responses in a safe setting.
- Expert-led sessions by Lieve Vrints, a clinical research auditing specialist with deep industry experience.
- Certification & assessment through ECCRT’s Virtual Campus to ensure knowledge retention.
Results
After ECCRT’s training, Inokura’s team felt significantly more prepared for audits:
- Increased confidence in handling inspections, knowing exactly what to expect.
- A stronger understanding of regulatory requirements and how to align their processes.
- More structured documentation and audit responses, leading to smoother interactions with auditors.
Why Choose ECCRT?
When it comes to audit and inspection readiness, experience matters. ECCRT stands out because we offer:
- 25+ years of industry expertise in clinical research training.
- Tailored learning approaches that adapt to your team’s specific needs.
- A proven track record training over 17,500 professionals in pharma, biotech, and academia.
- Certification & continuous learning to ensure long-term impact.
Get ready for your next audit
Want to ensure your team is fully prepared for audits and inspections?
Contact ECCRT today to learn more about our customized training solutions.
Email: info@eccrt.com
Website: www.eccrt.com