Summary

Quality by design is crucial throughout the clinical trial; it impacts every stage, from document management to technology procurement.

Prioritising this at the outset of the trial not only supports inspection readiness but can be crucial to the efficiency and effectiveness of the overall study.

To ensure inspection preparedness and readiness you must understand and acknowledge that quality assurance is an ongoing process and not just a one-off event.

Furthermore, embrace the inspection. As odd as that may seem, they can provide opportunities to improve your studies, ongoing or for the future. Always keeping inspection in mind throughout the trial will help facilitate passing one in the future, if harnessed correctly of course.

Lastly, take a holistic approach to integrity. It’s not just about the date, but also about the technology, process, people and culture. All these factors can impact integrity and thereby it is good practice to take all this into account throughout the trial.

Acknowledgements

We would like to thank the following for their valuable input, guidance and assistance that made it possible to publish this eBook:

Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting.

www.heath-barrowcliff-consulting.co.uk

About Arkivum

Arkivum, a world leader in digital archiving and preservation, guarantees the past, present, and future of valuable data. Expert and meticulous in handling data and digitised assets in large volumes and multiple formats, Arkivum offers a fully managed, end-to-end service that streamlines complex workflows and regulatory processes.

Championing good practice in the long-term stewardship and governance of data, Arkivum provides its diverse and prestigious customer base with a gold-standard, cost-effective service.

The integrity, security, findability, searchability and accessibility of archived data is key, and Arkivum rigorously applies the FAIR principles to data management – Findable, Accessible, Interoperable, Reusable. Arkivum offers customers a 100% data integrity guarantee, backed by insurance. Arkivum’s specialist software and services are chosen by leading institutions and commercial organisations as they take their digital transformation to the next level. We ensure compliance with professional and regulatory standards.