Speed trials to market

Speed trials to market

Compress study startup from weeks to days and accelerate time-to-market without adding regulatory staff. Automate literature review, protocol drafting, study package assembly, and submission preparation with AI agents, enabling regulatory teams to focus on strategic work.

Scale safety and quality

Scale safety and quality

Meet safety timelines even as AE volumes grow with new data channels. Agentic automation allows you to process more cases with the same team — automating across intake, MedDRA coding, and safety reporting — while maintaining GxP compliance and quality standards.

Unify molecule-to-market

Unify molecule-to-market

Standardize automation across R&D, clinical, regulatory, safety, and commercial with AI agents that work through a unified orchestration layer. Embedded security, human-in-the-loop controls, and audit trails, unify fragmented systems with governed, traceable automation.

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Deploy APA across life sciences operations

  • Research and Discovery
  • Clinical Ops and Trial Startup
  • Regulatory Affairs, Submissions
  • Pharmacovigilance, Medical Info
  • Manufacturing and Quality
  • Commercial Operations

Research and Discovery

Accelerate hypothesis testing and study design with your same team. Automate literature review, protocol drafting, data ingestion, and evidence curation with AI agents to free scientists for high-value work.

  • Literature review/synthesis
  • Study synopsis drafting
  • Multi-omics data ingestion
  • Metadata extraction
  • SDTM/ADaM/TFL packages
  • Evidence dataset curation
  • Biomarker/patient cohort ID

Clinical Ops and Trial Startup

Cut study startup delays. With APA, analyze site feasibility, assemble startup packages, manage ETMF documents, and track deviations to accelerate site activation and reduce manual coordination work.

  • Site feasibility analysis
  • Site selection/activation
  • Start-up package assembly
  • ETMF document QC, filing
  • Visit scheduling/reminder
  • Track issue/deviation/actions
  • Reconcile clinical data

Regulatory Affairs, Submissions

Speed submissions without overloading regulatory teams. Prepare submission content, validate documents, route health authority queries, and track commitments with agentic automation to accelerate regulatory cycles.

  • Regulatory intelligence
  • Submission content assembly
  • Technical validations
  • Label change management
  • Route health-authority query
  • Global submission tracking
  • Promo material compliance

Pharmacovigilance, Medical Info

Meet expedited safety timelines. Automate case intake, MedDRA coding, narrative drafting, and safety reporting with AI agents to process more cases without adding pharmacovigilance staff.

  • AE case intake
  • Triage and MedDRA coding
  • Narrative drafting
  • PSUR/DSUR/PBRER
  • Literature monitoring
  • Risk management tracking
  • Product complaint routing
  • Medical info inquiry triage

Manufacturing and Quality

Strengthen quality and traceability. Intelligently automate production operations, capturing batch records, managing deviations and CAPA, scheduling maintenance, and tracing product genealogy with APA.

  • Batch record data capture
  • Deviation, CAPA workflows
  • Maintenance scheduling
  • Clean room management
  • Product genealogy tracing
  • Qualify supplier/vendor
  • Shipping and receiving

Commercial Operations

Accelerate campaign launches and patient onboarding. Process contracts and rebates, route MLR reviews, manage patient support cases, and assemble payer packages with agentic automation.

  • Contracts and rebates
  • Reconcile sample, voucher
  • Door screening
  • Tender/payer packages
  • MLR review route/versions
  • Patient onboarding
  • Field insight capturing

Proven results for biotech and pharma teams

Merck
Merck
  • 150K hours saved per year
  • 64 business processes automated
  • 14 complex SAP systems automated

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Frequently asked questions

How does life sciences automation accelerate time-to-market?

Life sciences automation accelerates time-to-market by compressing study startup from weeks to days using orchestrated AI agents and bots to automate literature review, protocol drafting, study package assembly, and submission preparation. This agentic automation enables regulatory teams to focus on strategic work without adding staff while maintaining GxP compliance.

What pharmacovigilance tasks can life sciences automation handle?

Life sciences automation handles AE case intake, triage and MedDRA coding, narrative drafting, PSUR/DSUR/PBRER reports, literature monitoring, risk management tracking, product complaint routing, and medical info inquiry triage. Orchestrated AI agents and bots automate these tasks to meet expedited safety timelines and process more cases without adding pharmacovigilance staff.

How does life sciences automation support clinical operations?

Life sciences automation supports clinical operations by analyzing site feasibility, assisting site selection and activation, assembling startup packages, managing ETMF document QC and filing, scheduling visits, tracking issues and deviations, and reconciling clinical data. Agentic automation cuts study startup delays and reduces manual coordination work.

Can life sciences automation help with regulatory submissions?

Life sciences automation helps with regulatory submissions through orchestrated AI agents and bots that handle regulatory intelligence, submission content assembly, technical validations, label change management, health authority query routing, global submission tracking, and promo material compliance review to accelerate regulatory cycles without overloading teams.

What manufacturing and quality tasks can life sciences automation perform?

Life sciences automation performs batch record data capture, deviation and CAPA workflows, maintenance scheduling, clean room management, product genealogy tracing, supplier and vendor qualification, and shipping and receiving. Orchestrated AI agents strengthen quality and traceability across production operations.

How does life sciences automation support commercial operations?

Life sciences automation supports commercial operations by processing contracts and rebates, reconciling samples and vouchers, door screening, assembling tender and payer packages, routing MLR reviews, managing patient onboarding, and capturing field insights. Orchestrating AI agents and bots accelerates campaign launches and patient support case management.

Can life sciences automation maintain GxP compliance?

Life sciences automation maintains GxP compliance through governed AI agents that work with embedded security, human-in-the-loop controls, and audit trails as part of orchestrated agentic workflows. A unified orchestration layer connects fragmented systems across R&D, clinical, regulatory, safety, and commercial operations with governed, traceable automation.

How does life sciences automation handle research and discovery?

Life sciences automation handles literature review and synthesis, study synopsis drafting, multi-omics data ingestion, metadata extraction, SDTM/ADaM/TFL packages, evidence dataset curation, and biomarker and patient cohort identification. Agentic automation accelerates hypothesis testing and study design while freeing scientists for high-value work.

How can agentic solutions work for you?

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