About
Live Event at Biocom San Diego Office.

Inspection readiness is no longer a milestone to aim for at the end of the trial, instead it is a mindset that must be embedded throughout the clinical trial lifecycle. With increasing regulatory scrutiny, complex trial designs, and increasing data volume, it must be built into every aspect of trial execution. This Live Event at the Biocom – San Diego location will examine how organizations can shift from a reactive “checklist” approach to a proactive, data-driven model that leverages predictive analytics, performance metrics, and risk-based insights to embed inspection readiness across the entire lifecycle of a clinical trial.

Experts from Bioforum and Halloran Consulting Group will share strategies for transforming raw data into actionable insights that enable confident, real-time decision-making, enable early risk detection, and create a continuously inspection critical data repository.
When
Wednesday, September 17, 2025 · 4:00 p.m. Pacific Time (US & Canada) (GMT -7:00)
Agenda
  • Applying real-time analytics to monitor quality and mitigate risk, including dashboards, statistical trend analysis, and anomaly detection
  • Aligning early- and late-phase approaches to ensure continuity and consistency, with standardized data models, metadata strategies, and traceability across the lifecycle
  • Integrating evolving regulatory expectations into daily operations, ensuring audit-ready evidence to enable transparent regulator interactions
  • Creating a culture where inspection readiness is synonymous with operational excellence, measured with clearly defined KPIs
  • Sharing concrete examples of inspection critical data elements and other must-have items to be inspection ready
Presenters
T
Tanya Du Plessis
Chief Data Strategist & Solutions Officer, Bioforum The Data Masters
Tanya has more than 18 years of experience managing various data management operational teams. She is a certified Clinical Data Manager and Project Management Professional, and she holds an M.Med.Sc in Hematology and Cell Biology from the University of the Free State. In addition, Tanya serves as a board member and plays an active role in the Society of Clinical Data Management (SCDM) EMEA Leadership Committee.
S
Sheila Gwizdak
Vice President – Strategic Consulting Solutions, Halloran Consulting Group, a PLG Company
Forward-thinking executive with over 25 years of progressive leadership in life sciences, driving business transformation, organizational maturity, and regulatory success. Proven ability to lead high-performing teams, architect quality and operational frameworks, and deliver scalable solutions across the pharmaceutical and biotech landscape. Recognized for transforming complexity into clarity and enabling client success through strategic consulting, technology enablement, and risk-based decision-making.
G
Tim Scott
President and CEO, Biocom California
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