Reimagine trial coordination, pharmacovigilance, and regulatory submissions.
Three roles in pharma ops, where people and AI work together
Clinical trial coordination
Responsibilities to review
- Read the protocol and prior deviations
- Review site monitoring notes
- Draft the deviation note with classification
- Draft the corrective action plan
Illustrative workflow responsibilities. Confirm the tools, data, human decisions and review criteria for your work.
AI reads the protocol, prior deviations, site monitoring notes. Drafts the deviation note with classification (major/minor) and the corrective action plan. Coordinator reviews against the SOP and signs.
Pharmacovigilance case processing
Responsibilities to review
- Read the adverse event report
- Code MedDRA terms
- Assess causality
- Draft the seriousness call
Illustrative workflow responsibilities. Confirm the tools, data, human decisions and review criteria for your work.
AI reads the adverse event report, codes MedDRA, assesses causality, drafts the seriousness call. PV analyst reviews the flagged cases with full evidence chain surfaced.
Regulatory submission
Responsibilities to review
- Read the source data packages
- Review prior submissions and agency guidance
- Draft the submission section with cross-references
- Build traceability and cross-reference index
Illustrative workflow responsibilities. Confirm the tools, data, human decisions and review criteria for your work.
AI reads the source data packages, prior submissions, agency guidance. Drafts the submission section with cross-references and traceability. Regulatory manager reviews against the agency's expected dossier.
Reference workflows to adapt to your organization
Explore these reference workflows and adapt one to your organization. See a proposed division of work between people and agents, with decisions, responsibilities and handoffs. Task Intelligence provides the detail behind the redesign.
Quality Management
Pharma quality is high-stakes: deviation, CAPA, audit, change control. The redesign shows where agents own routine compliance work and where QA owns the regulatory judgment.
Talent Acquisition
Hiring clinical research staff, biostatisticians, regulatory professionals is credential-heavy and audit-tracked. The redesign collapses sourcing + screening + credential checks into parallel agent steps.
Procure-to-Pay
Pharma procurement spans regulated suppliers, controlled substances, validated systems. The redesign collapses vendor qualification + PO + payment release with audit trail intact.
Maintenance (Preventive/Predictive)
Validated lab and manufacturing equipment has GxP maintenance requirements. See how predictive agents fit into a validated maintenance workflow without breaking the audit trail.
Prepare your workforce for the redesigned work.
Your workforce brings people and AI agents together. Workflows define how they share the work. Define what agents do, who reviews their output, and when they hand work back. Use Task Intelligence to understand the tasks within each step, then prepare your people to build and run the new version through simulations, hands-on projects and skill validation. Revisit affected responsibilities and readiness when the work changes.
Task evidence within pharma workflows
These research inputs include vendor and source-reported software capabilities, product features and descriptions of work. The stored classifications in this selection contain 943 source examples for AI support and 631 for automation. They are not validated workflow outcomes or proof of agent performance. Task Intelligence helps examine the work in context; review each example against your responsibilities, controls and exceptions before using it in a redesign. The first 5 AI-support examples are below.
631 source examples classified for automation›
How we work with pharma orgs
Co-sponsored model. Functional head (Head of Clinical Ops, Head of PV, VP Regulatory) plus your transformation office in the room. The 6 to 8 week AI Bootcamp prepares people for agreed workflow responsibilities through simulations and assessments. Transformation Engagement scales across, same eTMF, same PV system, same GxP envelope.
Want a pharma-specific walkthrough?
20 minutes. We pull your top three task patterns from the dataset and show you the redesign live, with your role mix and your regulatory frame.
Book a time