Improving Sponsor Oversight of the Trial Master File at Chiesi

February 02, 2023 | 11:00 AM EST | USA

Regulators have made it abundantly clear – through recent guidance and inspection findings – that demonstrating sponsor oversight of an outsourced study is a critical requirement for TMF health and inspection readiness.

What’s more, having effective oversight is a critical commercial issue for sponsors, since getting a poor-quality TMF back at the study end can add significant remediation costs and risk to the marketing/submission strategy.

Join this webinar to discover how global biopharmaceutical company Chiesi and its CRO partners collaborate to ensure ongoing oversight compliance, in the face of increasing documentation requirements and trial complexity.

Our expert speakers will review current regulatory guidance in this area, share proven best practices for achieving and maintaining effective oversight of the Trial Master File, and examine what regulators will look for during an inspection such as:

• Evidence for active management of the trial around quality, completeness, and timeliness, with tracking of key metrics in each area
• Ongoing sponsor control over the study, as demonstrated by documented review and approval by the sponsor of the clinical study plan, monitoring plan, quality plan, and documentation supporting decisions made around study conduct
• Implemented and current SOPs, policies, and KPIs encompassing key processes, which are reviewed and shared with all parties involved in trial management
• The ability to authenticate documentation at every stage and create a complete audit trail for the Trial Master File

Speaker

Marisa Minetti

Eldin Rammell

Jenny Zecchini

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