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NEW ORLEANS, May 2 – ArisGlobal®, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today appears at Fierce Trial Master File (TMF) Summit, the cornerstone and must-attend event in clinical document management.
LifeSphere Clinical, the signature Clinical platform by ArisGlobal, will have a live presentation on site at the event, featuring Dario Lirio, Senior Director, LifeSphere Clinical Product Management. Lirio, who recently presented about ICH E6(R3) at SCOPE Summit 2022, will cover inspection readiness.
Session details are as follows:
● When: Tuesday May 3rd 4:45pm – 5:15 pm CT (30 minute duration)
● Agenda Track: Inspections and Audits Track
● Session Title: Remote and onsite inspections: Ready for both
In this session, you will learn how to:
● Prepare for both onsite and remote inspections and audits
● Avoid pitfalls when transitioning from a fully onsite program
● Improve collaboration with auditors and inspectors
● Stay responsive while reducing visit burden
● Make the process easier for inspectors and auditors
Dario brings almost 20 years of clinical experience to this conversation, and will offer insight into the continually changing landscape of clinical trials.
He shares, “The past two years we’ve seen a wider adoption of remote TMF inspections, out of necessity. While this eases the burden of some administrative tasks such as scheduling visits, it adds complexity at the management level. Remote visits require different SOPs, new workflows, and often new technology. They add an extra layer of work to audit and inspections planning. I’m looking forward to diving into this new complexity and offer insights on how to succeed in the inspection phase of clinical trials.”
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