CANDIDATE → FIH / IND-ENABLINGTranslational & FIH Strategy
Build an inspectable bridge from development-candidate evidence into early clinical planning without upgrading predictions into experimental facts.
Governed FIH v2PBPKPK/PDTK/NCAPreclinical gatesCMC/developability
Deliverables: FIH evidence package, MRSD/MABEL/PAD scenarios, exposure margins, uncertainty/risk register, SAD/MAD planning inputs, multidisciplinary review packet.
PHASE I / CLINICAL PHARMACOLOGYPharmacometrics & Early Clinical
Model human PK, characterize variability and optimize the studies needed to learn efficiently.
PopPK GoldPBPKPK/PD GoldOptimal DesignVPCSpecial populationsBE/bridging
Deliverables: PopPK workspace/model versions, sparse-sampling strategy, exposure simulations, special-population scenarios, model diagnostics, clinical pharmacology reports.
PHASE II / DOSE FINDINGDose Strategy & Proof-of-Concept
Connect measured efficacy/safety with exposure-response and trial operating characteristics to support a governed dose-selection decision.
Dose OptimusPK/PDTrial GoldAdaptive Trial StudioBiomarker & Endpoint
Deliverables: exposure-response package, active-dose set, uncertainty/evidence gaps, dose-ranging simulations, adaptive/futility scenarios, human dose-selection review packet.
PHASE III / CONFIRMATORYConfirmatory Trial Design Intelligence
Stress-test design assumptions before protocol/SAP decisions become expensive.
Trial GoldAdaptive TrialEstimandsClinical OutcomesGlobal Trial IntelligenceCredibility Studio
Deliverables: sample-size/power scenarios, group-sequential operating characteristics, endpoint/estimand review, protocol precedent, competitive evidence, model credibility packet.
SUBMISSION / REGULATORY MIDDModel Evidence & Traceability
Turn model runs and clinical evidence into a reproducible, reviewable chain rather than a folder of disconnected outputs.
PopPK versioningVPCCredibilityICH M15 framingGlobal Trials evidence graph
Deliverables: context-of-use record, model risk/impact rationale, verification/validation evidence, audit history, decision traceability and reviewer-response support.
POST-APPROVAL / PHASE IV / HEORRWD/RWE Evidence OS
Carry real-world datasets from harmonization through confounding diagnostics and treatment/safety evidence with an audit trail.
RWD intakeData qualityTarget trial/cohortConfoundingTreatment effectSafety signalEvidence grade
Deliverables: curated study dataset, causal-analysis evidence chain, safety/effectiveness analyses, evidence-grade and bias-risk record.