DecisionX for Pharma R&D
From first target to patent cliff, a drug moves through six stages, and at every one, a decision either gets made well and fast, or it gets made late, wrong, and expensive. Every stage runs on a clock; one of them never stops. This is where DecisionX plugs in at each stage.
Pharma R&D decision lifecycle
Six stages from Discovery to Lifecycle management, each shown as a gauge indicating relative severity of cost-of-delay, with Post-approval marked as perpetual.
Stage by stage
Each stage below shows the decisions made, the data they run on, what DecisionX solves, and what it costs to get them wrong or make them late.
Before a molecule exists, someone chooses which biological bets are even worth pursuing: the highest-leverage, least-evidenced decision in the entire lifecycle.
Ranks targets and leads against multiple weak, noisy signals at portfolio scale, forecasting probability of success per candidate against historical base rates instead of the loudest champion's confidence.
Average cost to bring one drug to approval is commonly cited near $2–3B; a wrong target choice means every downstream dollar, preclinical and clinical, is spent on a candidate that was never going to work.
Industry benchmarkThe patent clock often starts during discovery/preclinical filing, so slow triage quietly shortens the commercial exclusivity window before a single patient is dosed.
Industry benchmarkThe last checkpoint before human exposure: where a safety signal either gets caught on cheap animal data or surfaces later on expensive human data.
Diagnoses whether a preclinical safety signal is real or a model artifact, adjudicates the go/no-go decision with a documented evidence trail, and simulates human dose projection from animal data.
A missed safety signal that only surfaces in the clinic can kill a program after $50–100M+ of trial spend is already sunk, or worse, becomes a patient-safety event. A false-positive kill discards a potentially viable asset.
Industry benchmarkPreclinical typically runs one to three years; every added quarter here is a quarter off the eventual commercial exclusivity runway, and a gift to whichever competitor reaches the clinic first.
Industry benchmarkThe stage with the sharpest, most measurable clock in the entire lifecycle, where DecisionX's current pharma engagement evidence is concentrated.
Reconciles inconsistent site-history definitions, forecasts per-site enrollment curves, flags amendment-risk design elements before lock, and simulates trial dynamics with pre-committed contingency triggers.
Roughly half of kill/continue decisions are made after the statistically optimal point; a failed Phase III alone commonly runs into the hundreds of millions to over $1B in sunk cost.
SourcedApproximately $500K per day of trial delay, the highest dollar-per-day figure anywhere in the pipeline, because every day compounds against a fixed patent clock and competitive window.
SourcedThe narrowest gate in the lifecycle: a single verdict from a single reviewer body that either opens the market or costs a year.
Diagnoses which dossier elements historically trigger delays or rejections at each regulator, adjudicates first-cycle-approval readiness before submission, and prioritizes market-filing order under finite regulatory-affairs capacity.
A rejection or Complete Response Letter can delay launch six to eighteen-plus months and cost additional millions to resubmit, while competitors use the window to capture share.
Industry benchmarkEvery month of filing delay is a month of exclusive-market revenue that is permanently lost, not merely deferred: for a blockbuster asset, that can be $50–100M+ per month.
Industry benchmarkThe one stage with no finish line: every case, forever, on a clock that resets with each new report and never fully stops.
Extracts case facts from eight unstructured, multilingual source types, scores causality across drug classes, and delivers a near-touchless verdict, pulling humans in only on flagged exceptions.
Manual extraction runs roughly 60% accurate with human error at 20–30%; a missed real signal risks patient harm and, at the extreme, product withdrawal, among the highest reputational and legal costs in the lifecycle.
SourcedA missed 15-day regulatory deadline is a compliance violation on its own, per case, forever: not a one-time risk but a perpetual operating exposure across the entire portfolio.
SourcedThe stage where the calendar decides for you: patent cliffs don't wait for a decision to be ready.
Prioritizes which indications or label expansions to pursue under a finite medical-affairs and R&D budget, forecasts revenue-at-risk against the patent-expiry calendar, and surfaces evidence gaps before a competitor files first.
Losing an indication-expansion race to a competitor can hand away hundreds of millions in incremental revenue in an adjacent patient population.
Industry benchmarkPatent cliffs are fixed dates, not moving targets: generic erosion commonly claims 70–90% of sales within the first year post-exclusivity, so every quarter of delayed defense is revenue that cannot be recovered later.
Industry benchmarkThe System
Why enrollment stalled, a case is causal, or a protocol needs to change.
Every site ranking and ICSR verdict sharpens the next cycle.
CRO, EDC, and eight spontaneous-report sources reconciled first.
Decision AI for Pharma R&D
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