Evidence Pack Catalog
Browse our library of AI-powered evidence packs spanning oncology, regulatory strategy, biomarker science, CMC quality, and competitive intelligence. Each pack delivers audit-ready deliverables backed by validated sources.
Oncology Trial Design Pack
Design smarter trials with real-world precedent data
Generates evidence-backed oncology trial design recommendations using historical protocol analysis, endpoint benchmarking, and regulatory precedent.
OncologyFDA IND Strategy Pack
File your IND right the first time
Assembles FDA IND filing precedents, module-level requirements, and common deficiency analysis to accelerate IND preparation and reduce clinical hold risk.
Regulatory StrategyDose Optimization Pack (Project Optimus)
Navigate the new dose optimization paradigm with confidence
Compiles FDA Project Optimus requirements, dose-finding trial precedents, and CDER review expectations to support oncology dose optimization strategies.
OncologyAccelerated Approval Evidence Pack
Build a bulletproof accelerated approval submission
Compiles FDA accelerated approval precedents, surrogate endpoint acceptance history, and confirmatory trial requirements to support accelerated approval strategies.
OncologyBreakthrough/Fast Track Evidence Pack
Maximize your chances for expedited designation
Compiles FDA expedited program precedents, designation request strategies, and acceptance criteria analysis to support Breakthrough Therapy and Fast Track applications.
Regulatory StrategyBiomarker-Driven Trial Design Pack
Turn molecular insights into registration-ready trial designs
Synthesizes FDA biomarker guidance, published biomarker-selected trial data, and diagnostic approval history to support biomarker-driven oncology development.
OncologyPre-Submission Meeting Prep Pack
Walk into every FDA meeting fully prepared
Generates structured meeting briefing documents, question strategies, and precedent-based response preparation for FDA Type A, B, and C meetings.
Regulatory StrategyImmuno-Oncology Combination Pack
Build the regulatory case for your IO combination
Aggregates IO trial data, FDA combination therapy guidance, and published IO combination outcomes to support immuno-oncology combination development strategies.
OncologyFDA/EMA Alignment Pack
Harmonize your global regulatory strategy
Maps FDA and EMA regulatory requirements side-by-side, identifies alignment opportunities, and flags divergent expectations to support global development planning.
Regulatory StrategyReal-World Evidence Oncology Pack
Leverage real-world data for regulatory-grade evidence
Compiles FDA RWE framework guidance, RWD source evaluations, and published RWE submission precedents to support real-world evidence strategies in oncology.
OncologyCompetitive Landscape Pack
Know every competitor before they know you
Maps the competitive landscape for your therapeutic area including pipeline assets, clinical trial activity, regulatory milestones, and strategic positioning analysis.
Competitive IntelligenceOncology Safety Signal Pack
Anticipate safety signals before they derail your program
Analyzes FDA safety databases, REMS precedents, and post-marketing safety data to identify and contextualize potential oncology safety signals.
OncologyGlobal Regulatory Intelligence Pack
Track regulatory shifts across 40+ markets in real time
Monitors global regulatory changes, guideline updates, and policy shifts across major pharmaceutical markets to support proactive regulatory strategy adjustments.
Regulatory StrategyMarket Access Evidence Pack
Build the value story payers need to hear
Compiles health economics data, payer landscape analysis, and reimbursement precedents to support market access strategy and value dossier development.
Competitive IntelligenceBiomarker Validation Pack
From candidate biomarker to qualified decision tool
Provides evidence frameworks for analytical validation, clinical validation, and regulatory qualification of biomarkers across therapeutic areas.
Biomarker & TranslationalCompanion Diagnostic Strategy Pack
Align your drug and diagnostic development timelines
Maps companion diagnostic co-development requirements, FDA PMA/510(k) precedents, and diagnostic partnering strategies for biomarker-driven programs.
Biomarker & TranslationalPediatric Oncology Strategy Pack
Navigate pediatric oncology requirements with regulatory clarity
Synthesizes RACE Act requirements, FDA pediatric study plans, and pediatric trial outcomes to support pediatric oncology development strategies.
OncologyTarget Validation Evidence Pack
Validate your target with multi-source evidence synthesis
Synthesizes genetic association data, functional genomics evidence, and clinical target validation precedents to build comprehensive target validation dossiers.
Biomarker & TranslationalPost-Approval Commitment Tracker Pack
Never miss a post-approval obligation deadline
Tracks and manages post-marketing requirements, commitments, and REMS obligations with precedent-based timelines and compliance monitoring.
Regulatory StrategyPK/PD Modeling Intelligence Pack
Model-informed drug development backed by precedent
Aggregates pharmacokinetic/pharmacodynamic modeling precedents, FDA MIDD guidance, and published population PK analyses to support model-informed development strategies.
Biomarker & TranslationalPatent & Exclusivity Intelligence Pack
Map the IP landscape before it maps you
Analyzes patent landscapes, regulatory exclusivity timelines, and freedom-to-operate considerations for drug development programs.
Competitive IntelligenceExcipient Justification Pack
Justify every excipient with regulatory-grade evidence
Compiles excipient safety data, FDA Inactive Ingredient Database precedents, and formulation rationale evidence to support excipient justification in regulatory submissions.
CMC & QualityComparability Strategy Pack
Navigate manufacturing changes without derailing your program
Assembles FDA and ICH comparability guidance, precedent manufacturing change assessments, and analytical comparability study designs for post-change submissions.
CMC & QualityProcess Validation Narrative Pack
Build a validation narrative that reviewers trust
Generates process validation lifecycle narratives using FDA and ICH guidance, validation precedents, and statistical approaches for continued process verification.
CMC & QualityAdvanced Manufacturing Pack
Regulatory intelligence for next-generation manufacturing
Compiles FDA advanced manufacturing guidance, continuous manufacturing precedents, and emerging technology regulatory pathways for innovative manufacturing approaches.
CMC & QualityShowing 25 of 25 evidence packs