Get the label right the first time.
Attribution that’s accurate during the trial gives you the right label, the right dosing interval and the right monitoring schedule at approval. Burna scores it at the encounter, at every site, with the evidence attached. Your protocol stays inside your own cloud.
The label you write once.
An event caught during the trial becomes a line in your label. The same event found after approval becomes a label change, a safety communication, a revised dosing interval, and the spend to take the drug back out. Separating the true and related from the true and unrelated early is where that money is made.
Caught during the trial
One line in your label.
The dosing interval, the monitoring schedule and the warnings, right the first time.
Found after launch
A label change.
- A safety communication.
- A dose adjustment.
- The cost of taking a drug back to market.
One adverse event, and the two futures that fork at approval. Illustrative rendering.
“If I have a delay on a study of three months… this drug two years later will be a blockbuster. A billion dollars in one quarter of a year. A billion dollars is 250 million dollars missing… And a patient who has metastatic disease may not have a quarter year of time to wait for the drug.”
The attribution decision is made at 40 to 200 sites.
Trials are heterogeneous in how carefully sites document, and the sponsor sees the variance months later at central review. Burna grades every site against the same criteria and the same algorithms, and surfaces the spread while the trial is running. During amendment implementation, sites operate under mixed protocol versions for a median of 215 days. Amendment-driven attribution updates should propagate in hours.
share of events each site attributes to the study drug
Forty sites on one trial
amendment approved
all sites aligned
median 215 days (mixed protocol versions)
real-time propagation: hours
One protocol, forty sites, forty documentation habits. Illustrative rendering.
Source: Tufts CSDD.
Every safety platform you own starts after the decision.
Argus, LifeSphere and Vault Safety manage the ICSR lifecycle once attribution has already been made. Burna is where the investigator makes it, with WHO-UMC and Kramer scoring shown per drug, the supporting evidence in view, and the reasoning inspectable before anything is signed.
clinical encounter
Attribution decision
ICSR lifecycle (Argus, ArisGlobal, Vault...)
Burna operates here
every existing vendor
Upstream of the ICSR.
seconds
next monitor visit
EVENT
SITE 01
SITE 02
SITE 03
SITE 04
SITE 05
SITE 06
SITE 07
SITE 08
Illustrative rendering
Finding the low-grade events early is upside.
Finding the low-grade events early is where the upside sits. A serious event genuinely attributable to your agent surfaces eventually, and it is far cheaper to hold at the label stage than after a safety communication. Grade 1 and grade 2 events are what tell you the dosing interval wants changing, the schedule wants changing, or a subpopulation is carrying risk your protocol anticipated differently. The dose you want often sits below the maximum tolerated dose.
“Pharma is going to be conflicted because they kind of wish there weren't any. It's a little bit like going to a health system and saying we're going to look for HIPAA violations.”
Your protocol stays inside your own cloud.
Attribution scored from your protocol, on infrastructure you hold. The protocol stays inside your cloud, and the boundary is fail-closed by architecture.
Sponsor cloud: protocol
Burna: attribution intelligence
Content Boundary Middleware, fail-closed
The protocol stays inside your own cloud.
The same engine keeps working after approval.
Your postmarket events run through the same engine and come back as submission-ready narratives. Every output carries the criterion it was graded against and a 21 CFR Part 11 signature, so an inspector opens the same evidence your investigator signed.
An estimated 11% of deaths in oncology are attributable to poor adverse event management.