Change without chaos: Orchestrating CDISC & terminology updates

SDTM 3.2, ADaM 3.2, and SEND 4.2 are advancing at the same time, alongside a controlled terminology update every six months. Most sponsors and CROs are managing that convergence release by release instead of with a defined process.

In this session, Rajesh Saha breaks down what’s actually driving the volatility, from version fragmentation across active studies to the resource strain of continuous retraining to the compliance risk of confusing a still-in-review standard with a production-ready one. He then walks through a five-step CDISC & terminology updates change management framework and shows how Pinnacle 21 Enterprise supports each stage, from surfacing new metadata releases to comparing study data against updated standards to documenting every decision, approved or not.

Watch the recording to get a practical playbook for managing CDISC and terminology updates on your terms, instead of reacting to each one as it lands.

• Why the SDTM, ADaM, and SEND convergence in 2025 and 2026 creates more operational risk than a typical update cycle
• The three specific failure points sponsors and CROs are running into: validation instability, resource burnout, and compliance gaps
• A five-step change management framework: monitor, assess impact, decide and document, implement, and approve and publish
• How to decide whether to adopt a new standard early or wait for a regulatory mandate
• How Pinnacle 21 Enterprise supports every stage of the process, from monitoring releases to documenting change decisions