Measure How Adverse Event Cases Are Processed and Identify Where to Reduce Cycle Time
Pyze measures how case intake, triage, medical coding, case processing, narrative writing, quality review and regulatory submission are performed, and identifies where automation and AI agents apply within the reporting clocks.
Engagement archetypes from Pyze deployments across regulated operations rather than a single named account. Pyze measures how work is performed and does not assess the content of any case.
Pharmacovigilance teams process adverse event reports that arrive by email, fax, call center, partner exchange and literature, and each case must be assessed, coded, reviewed and submitted within a regulatory clock. The safety database records each case status, but it does not record the work between statuses: duplicate searches, follow-up requests, MedDRA term selection, narrative drafting and quality review rework. Pyze measures that work. Pyze does not make safety, clinical or compliance determinations.
Common Findings in Drug Safety and Pharmacovigilance
Four patterns that recur across engagements, each shown with the measurement and the resulting change.
Case intake receives reports in many formats, and staff transcribe source documents into the safety database before triage can begin.
AutomatePyze measures the time spent between the source document, the email client and the safety database during intake, and identifies which source types require the most re-entry and duplicate searching.
Structured intake from known source types is completed without transcription, and cases that need review arrive with the source fields already placed for the case processor to confirm.
Medical coding of events, drugs and indications is performed case by case, and coders look up the same terms repeatedly.
AgentifyPyze measures the sequence of coding tool, dictionary and safety database interactions for each case and identifies the share of coding steps that repeat a term already coded in the same or an earlier case.
Term suggestions are prepared from prior coding decisions for the coder to confirm, and the coder time is directed to the terms that need medical judgment.
Narrative writing and quality review are separate steps, and cases are returned to the processor after review for corrections to the same recurring items.
StandardizePyze measures the number of times each case moves between processing and review, and the time between each handoff. Recurring return reasons can be matched to case types and to the stage where the item was entered.
The recurring return causes are documented and addressed at the point of entry, which reduces review loops without changing the review standard.
Cases approaching a reporting clock are expedited by team leads, and the remaining work waits behind them.
RebalancePyze measures the distribution of cases across processors and the time each case waits between stages. Queue imbalance ahead of submission deadlines is visible by case type and by site.
Case allocation is leveled across processors and sites against the measured workload and the remaining time on each clock.
Opportunity Register
A sample register, sorted by the lever that resolves each opportunity. In an engagement, each line carries measured hours, a named owner and the evidence it was derived from.
Systems typically instrumented
Capture covers browser-delivered and thick-client applications, including virtualized estates, with no change to how anyone works.
Roles Involved
Instrumentation is configured per application rather than per person, so the population in scope is set during scoping and is not a deployment constraint.
How an Engagement Runs
Baseline, blueprint, transform, prove
The same four stages apply in every sector. The fourth stage repeats the baseline measurement, which makes the engagement an ongoing operating capability rather than a one-time report.
Baseline
What the work costs today, measured across every person and application.
Blueprint
Procedures, application rules and execution evidence, read as one target state.
Transform
Where each of the five levers applies, priced and owned.
Prove
The after state measured against the baseline, using the same method.
Frequently Asked Questions
Does Pyze make safety or compliance determinations?
What data does Pyze collect in a regulated environment?
Our safety database already reports cycle times by status. What does this add?
How does this relate to validation of changes to the safety system?
Associated Titles
Industries
Roles
Other functions
Related
Start with a measured baseline
Six weeks from instrumentation to a priced opportunity register, and the baseline stays in place so later quarters are measured rather than re-estimated.