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Tailored pharma intelligence for every life sciences function—from preclinical R&D to commercialization.
Automated insights and strategic intelligence across the pharmaceutical lifecycle
Transform preclinical insights into clinical strategy with comprehensive target analysis, biomarker landscapes, and mechanism validation across therapeutic areas.
Navigate dose-finding complexities with real-time competitive benchmarking, biomarker correlation analysis, and proof-of-concept validation strategies.
Optimize pivotal study protocols through comprehensive endpoint analysis, comparator selection insights, and regulatory precedent intelligence.
Streamline approval pathways with automated regulatory intelligence, precedent analysis, and comprehensive submission package preparation.
Accelerate trial initiation with intelligent site feasibility analysis, protocol optimization insights, and competitive recruitment intelligence.
Enhance enrollment strategies through patient journey mapping, competitive trial analysis, and real-time recruitment benchmarking.
Ensure submission-ready data through automated quality checks, regulatory compliance monitoring, and cross-study data harmonization.
Prepare for regulatory inspections with comprehensive documentation review, audit trail verification, and compliance gap analysis.
Validate market opportunity through comprehensive landscape analysis, payer perception research, and early value proposition development.
Build compelling value narratives with integrated HEOR evidence, competitive differentiation analysis, and stakeholder-specific messaging.
Orchestrate successful launches through market access planning, KOL engagement strategies, and competitive response preparation.
Execute go-to-market strategies with real-time competitive monitoring, payer negotiation support, and launch performance tracking.
Guide go/no-go decisions with comprehensive pipeline assessment, competitive positioning analysis, and partnership opportunity identification.
Inform strategic decisions through real-time efficacy benchmarking, M&A target evaluation, and portfolio optimization analysis.
Navigate critical decisions with scenario planning, competitive threat assessment, and cross-portfolio synergy identification.
Maximize ROI through resource allocation modeling, competitive response planning, and market entry timing optimization.
Align diverse stakeholders through automated reporting, investor intelligence, and patient advocacy insights.
Synchronize teams with unified evidence platforms, real-time milestone tracking, and integrated decision support.
Streamline external communications with automated report generation, regulatory response preparation, and investor deck updates.
Coordinate market preparation through evidence synthesis, patient pathway analysis, and payer communication strategies.
Knolens is an AI-powered intelligence platform designed to unite R&D, Clinical Development, Market Access, and Commercial teams across pharmaceutical organizations in Boston, New Jersey, Basel, London, and global markets with real-time intelligence for faster validation and better outcomes across development pipelines.
Knolens gives pharma teams real-time visibility with 500+ sources (ClinicalTrials.gov, FDA, EMA) to model strategies, detect risks, and optimize protocols.
Automate systematic literature reviews with 95%+ accuracy for regulatory submissions and HTA dossiers. Process thousands of publications in hours meeting FDA 21 CFR Part 11 compliance.
Monitor FDA, EMA, PMDA regulatory changes in real-time. Track competitor approvals and safety signals with complete audit trails.
Optimize investments using AI-driven competitive intelligence across oncology, immunology, neuroscience, and rare diseases.
Enable seamless intelligence sharing between global teams. Integrate with Veeva Vault, Microsoft Teams, and SharePoint.
Cut study design cycles and speed time-to-first-patient by 40%.
Proactively anticipate and address payer and HTA objections
Optimize evidence generation strategies for market-specific value demonstrations
Enhance cross-market pricing, reimbursement, and access strategies
Improve coordination between global and local pharmaceutical teams
Strengthen value-based contracting with robust, defensible evidence
Knolens accelerates scientific due diligence, clinical strategy validation, and competitive analysis—empowering biotech teams in Kendall Square, Cambridge, San Francisco, and emerging hubs to move faster, reduce risk, and build stronger development narratives for investors and partners.
Accelerate asset validation with real-time data analysis. Identify optimal targets and mechanisms of action through 400,000+ clinical trials, competitive intelligence, and real-world evidence, while proactively assessing FDA regulatory and payer landscapes.
Design optimized protocols using AI analysis of similar trials. Identify ideal endpoints, biomarkers, and patient populations with 95%+ accuracy.
Build compelling investor presentations with validated market sizing, competitive positioning, and regulatory pathway analysis backed by traceable evidence.
Validate targets and mechanisms 80% faster with AI research.
Design smarter clinical trials with higher probability of success
Conduct market landscape assessments without large teams
Strengthen investor and board presentations with defensible data
Perform scientific and commercial due diligence at fraction of traditional costs
Knolens enables Contract Research Organizations to streamline evidence generation, monitor regulatory shifts, and deliver sponsor-ready insights—accelerating timelines while maintaining GxP compliance and full traceability for pharmaceutical sponsors.
Generate protocol-specific literature reviews by trial phase, therapeutic area, and region. Automate extraction of comparators, endpoints, biomarkers, and regulatory precedents with full source traceability for audits and sponsor validation.
Track FDA, EMA, PMDA updates affecting ongoing trials. Receive real-time alerts on safety signals and regulatory changes.
Generate audit-ready reports meeting pharmaceutical sponsor requirements with complete evidence traceability and 21 CFR Part 11 compliance.
Monitor competitor trials for protocol optimization and site selection intelligence across therapeutic areas.
Customize deliverables with sponsor branding for seamless integration into pharmaceutical workflows.
Accelerate sponsor project delivery—reduce evidence synthesis from weeks to hours
Scale across multiple sponsors with automated pipelines
Reduce manual burden for medical writers and scientific teams
Ensure Regulatory Compliance and Audit Readiness
Increase Sponsor Satisfaction and Win Repeat Business
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Knolens supports Regulatory, Clinical, and Commercial teams managing Class II/III medical devices—simplifying MDR, IVDR, and FDA compliance while accelerating global market readiness across US, EU, and APAC markets.
Monitor FDA, CE mark, and global regulations across device classes. Access filterable evidence by indication and region. Anticipate MDR/IVDR changes affecting trials and market strategies.
Analyze competitor labels and claims across markets. Ensure compliance with regional requirements while optimizing differentiation.
Generate evidence packages for regulatory submissions and HTA dossiers with health economic modeling support.
Track NICE, G-BA, HAS decisions for similar devices. Build value narratives for payer negotiations.
Automate 510(k), PMA, and CE mark documentation with complete traceability and audit trails.
Reduce compliance risk by tracking global regulatory shifts
Streamline labeling and clinical documentation across markets
Accelerate Evidence Readiness Across Safety, Performance, and Cost-Effectiveness Domains
Enhance Regional Submission Readiness with Audit-Ready, Referenced Outputs
Unify Regulatory and Commercial Teams Around Shared Data and Evidence Models
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Knolens delivers tailored pharmaceutical intelligence for consulting firms—enabling faster insights, sharper strategies, and greater impact across therapeutic, regulatory, and commercial projects for Big Pharma and biotech clients.
Instantly access structured intelligence across oncology, immunology, neuroscience, and rare diseases with advanced filters—cutting data collection time to focus on strategy development.
Generate client-ready reports with 95%+ accuracy from 500+ pharmaceutical data sources including clinical trials, publications, and regulatory databases.
Analyze global reimbursement decisions, pricing strategies, and market access pathways across US, EU, and emerging markets.
Build dynamic competitive landscapes and what-if scenarios for strategic planning and portfolio optimization.
Customize outputs with client branding and pharmaceutical-specific formatting for immediate use.
Accelerate pitch-to-delivery timelines by minimizing upfront research
Equip junior team members with validated insights and plug-and-play modules
Expand into new therapeutic areas with pre-curated, regularly updated data
Differentiate your firm with real-time, AI-driven insights
Strengthen client trust through structured, defensible, recommendations
Win more business with faster, smarter, proposals backed by evidence
Trusted by global pharma, biotechs, and life sciences leaders
Knolens has transformed the way we work. Pienomial's relentless focus on innovation helps us stay ahead in a highly competitive landscape.
With Knolens, what used to take weeks of manual review now takes minutes—and we can trust every result.
Knolens has transformed the way we work. Pienomial’s relentless focus on innovation helps us stay ahead in a highly competitive landscape.
With Knolens, what used to take weeks of manual review now takes minutes — and we can trust every result.
