Turn Mandatory Medical Review Into a Live, Operational Workflow
Every clinical trial must conduct an ongoing Medical & Safety Review (MSR) in accordance with ICH-GCP. However, most teams still perform it through manual Electronic Data Capture (EDC) navigation, fragmented patient listings, and email-driven query follow-up without an audit trail. CluePoints MSR is the intelligence layer that turns this mandatory, high-stakes process from a static, manual exercise into a live operational workflow: faster insight, lower Data Management (DM) burden, and audit-ready compliance from first patient to database lock.
Everything Your Medical Review Workflow Needs
CluePoints MSR is purpose-built for mandatory ICH-GCP medical and safety review, not repurposed from a generic analytics or visualization platform. Every capability connects data, insight, action, and documentation in a single continuous process, reducing time-to-insight, eliminating programming dependencies, and delivering a complete audit trail as a byproduct of how the work flows.
How Teams Use CluePoints MSR
Focus on What Changed, Not Everything That Exists
Traditional medical and safety review requires monitors to navigate raw EDC data, run custom listings, and manually compare current data against prior reviews. Most of that time goes to data assembly, not clinical assessment. CluePoints MSR delivers scheduled, structured data pulls with delta views that surface only what changed since the last review. Reviewers focus on meaningful clinical signals. Review cycles become faster and more predictable. Issues surface earlier, with the full patient context already assembled in one place.
- Scheduled EDC data pulls with delta highlighting across all data domains
- Automated patient flagging and pre-defined filters for rapid outlier identification
- Review completion tracking visible to medical monitoring leadership
Eliminate the Programming Dependency for Every Review Cycle
In most organizations, medical and safety review depends on the DM and programming teams to build and maintain custom listings for each study and each review cycle. Those listings require reprogramming whenever protocols change or medical monitors need a different view. CluePoints MSR eliminates this cycle. Key-variable mapping enables a compliant review directly on operational EDC data without an abstraction layer transformation. After the first study, configuration reuse within the same therapeutic area is approximately 80%. DM capacity recovered from listing maintenance does not return.
- Key-variable mapping: compliant review on operational EDC data, no abstraction layer required
- Approximately 80% configuration reuse within the same therapeutic area
- No ongoing programming support required for review cycle delivery
Same Standard, Every Reviewer, Every Study
Without a structured workflow, review approaches vary. Prioritization differs. Even experienced reviewers apply different thresholds and reach different conclusions from the same data. Under modern regulatory expectations, that variability is not an acceptable feature of the process. It is a risk. CluePoints MSR standardizes review through configurable rules and delta-based workflows that ensure every reviewer follows the same approach, every review cycle surfaces the same signals, and every decision is traceable to the same documented standard, regardless of who is reviewing or which study they are on.
- Configurable review rules ensuring consistent prioritization across all reviewers
- Variable-level delta changes highlighting new and amended data at each review cycle
- Reusable dashboard configurations across studies in the same therapeutic area
Predictable Review Economics as Your Portfolio Grows
MSR is structured for portfolio reuse. The first study carries the configuration investment. Every study after reuses approximately 80% of that setup within the same therapeutic area. As the portfolio grows, per-study setup effort declines, operational costs stabilize, and medical and safety review coverage expands without a proportional investment in DM or Professional Services. For organizations committing to a minimum of five studies, the economics shift decisively, and the transition from Excel to MSR becomes a structural upgrade to how clinical oversight functions at scale, not just a quality improvement.
- Declining per-study configuration effort across a growing portfolio
- Predictable commercial economics beginning at a minimum five-study commitment
- Expanding MSR coverage without proportional increase in DM or Professional Services effort
The Work Has Not Changed.

What Regulators Expect Has.
Regulators are no longer asking whether a medical and safety review happened. They are asking whether it was timely, proportionate, justified, and traceable. Under ICH E6(R3), traceability is not optional. It is the foundation of defensible oversight. CluePoints MSR builds that evidence trail automatically as part of the review workflow, so the answer to every regulatory question is already in place before the question is asked.
Medical & Safety Review for Every Scale
Related Resources
Download: Medical & Safety Review: From Event to Insight
Download: MSR Fact Sheet
Event: Register for RBQM Live 2026
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