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i2e Consulting at the ACDM RBQM Symposium 2026

ACDM RBQM Symposium 2026

4th Annual ACDM Symposium on Risk Based Quality Management

November 9–10, 2026 
Clayton Hotel Dublin Airport Central, Dublin, Ireland

i2e Consulting presented at the ACDM RBQM Symposium 2026.

Many organizations have adopted RBQM but still struggle to produce consistent, trusted risk signals, often because their data is available but not usable. We help close that gap by harmonizing clinical data, standardizing how it is prepared and validated, and building Analysis-Ready Datasets that scale central monitoring across studies.

Usable by design. From available data to trusted risk signals.

What if every study's risk signals came from data that was already analysis-ready, instead of data rebuilt study by study?

Early RBQM programmes often rely on study-specific data preparation and manually maintained workflows. They work for one study, but are hard to validate, standardise and scale, so risk signals vary from study
to study and decisions wait on manual effort. i2e helps organisations
treat data readiness as a shared, governed capability: harmonising
clinical data sources, standardising how data is transformed and vali dated, and giving the business clear ownership of what “analysis-ready” means. The result is more consistent risk signals and more proactive oversight across the portfolio.

Three lessons from our session:

The session was presented through a business and operational lens, with practical examples rather than implementation detail, so it is relevant to clinical operations, quality, data management and program leaders as much as to technical teams.

RBQM stalls when data is available but not consistently usable.

Reliable risk signals depend less on analytics sophistication and more on how data is prepared, structured and maintained across studies.

Scaling RBQM means moving from study-level solutions to shared data workflows.

Standardizing how data is integrated and prepared enables consistent oversight and reduces duplication.

Early decisions on data, validation and architecture shape long-term success.

These foundations determine how well organisations can scale risk oversight and adopt automation and AI over time.

The session also looked at how Analysis-Ready Datasets create the foundation for risk-based data management, a key focus of this year's symposium. If you missed it, you can read our abstract and continue the conversation with our team.

Our session at the
ACDM RBQM Symposium 2026

i2e presented From Data Availability to Data Usability:
Operationalizing RBQM with Analysis-Ready Datasets on November 10, 2026
View our abstract >  

About i2e

i2e Consulting helps pharmaceutical and biotech organizations connect the data, workflows and decisions behind clinical trial execution, bringing 15+ years of life sciences domain expertise to clinical data and RBQM, resource management, clinical supply and portfolio planning.

What we do:

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Analysis-ready
datasets

Datasets defined with business-led readiness criteria and maintained as long-lived operational assets, not one-off study deliverables.

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Shared data
workflows

Harmonized clinical data sources, standardized transformation frameworks and fit-for-purpose validation, on platforms such as Databricks.

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Foundations for
RBDM & AI 

Early decisions on data, validation and architecture, so organizations can scale risk-based data management and adopt automation and AI over time.

Speakers at the event

Azeem Shaikh
Azeem Shaikh
Principal Clinical Solutions Architect – Data and AI, i2e Consulting
Malgorzata S
Malgorzata S
Director Program Lead - Data Surveillance, Pfizer

Thank you to everyone who joined our session and connected with our team in Dublin. If you'd like to discuss how we may help you make RBQM data consistently usable across your studies, get in touch.

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