Become an
AI-native CRO.
Put AI agents to work across your clinical trial workflows, with shared study context, connected evidence and expert control.
Start with one workflow. Connect the next using the same systems and permissions.
A unified platform
without a costly migration
Connect clinical operations across existing systems and SOPs. Reuse connections and workflows across studies, while keeping each sponsor’s data within its access boundaries.
Your existing environment
Shared context. Scoped access.
Connected context + permissions
Specialist agents, working together
From scattered inputs
to review-ready work.
A clear path from pending to ready.
Bring site correspondence, equipment capabilities, staff training and protocol-specific requirements into one readiness view. Identify missing evidence, draft follow-ups and track open actions, owners and status.
Study & country requirements · Site correspondence · Readiness checklists · Training records · Equipment & system information
Collect
Consolidate correspondence, records and evidence of protocol-specific setup.
Check
Identify missing evidence and unresolved readiness prerequisites.
Coordinate
Draft follow-ups; track actions, owners and status.
Authorized staff confirm readiness and approve next steps.
Ready to review
Site readiness pack
- Confirmed readiness with supporting sources
- Missing evidence and unresolved prerequisites
- Open actions, owners and draft follow-ups
Pilot measureTime to a reviewed readiness pack
Less status chasing. Earlier action.
Reconcile milestones, site readiness, action logs and team updates. Flag inconsistencies and delays, and prepare a sourced sponsor update with the actions that need attention.
CTMS milestones · Site readiness · Action logs · Team updates
Collect
Bring together the latest updates.
Reconcile
Flag conflicts, delays and gaps.
Draft
Prepare a sourced status brief.
Project manager confirms the picture and approves communications.
Ready to review
Study oversight brief
- Milestone changes and readiness blockers
- Overdue actions by owner
- Sourced draft sponsor status report
Pilot measureHours spent preparing each status cycle
Clinical trial protocol preparation.
Research relevant precedents, compare endpoints and study durations, and develop protocol sections with your experts. Keep supporting evidence, expert decisions and unresolved questions together as the approach evolves.
Sponsor brief · Indication & molecule · Study phase · Geography · Relevant evidence · Approved templates
Research
Retrieve precedents, evidence and relevant regulatory requirements.
Compare
Compare options, ask for missing inputs and record expert choices.
Prepare
Draft sections from expert decisions and flag inconsistencies.
Medical, statistical and operational experts determine the study design.
Ready to review
Protocol preparation pack
- Sourced evidence summary
- Expert decisions and open questions
- Protocol draft for review
Pilot measureTime to expert-reviewed protocol sections
Find the gaps before the handoff.
Check the trial master file (TMF) against expected study records. Organize completeness and quality findings into a review queue, while keeping the eTMF as the system of record.
Study documents · Expected document lists · Filing rules
Classify
Suggest document types and metadata.
Check
Flag missing, duplicate or outdated records.
Route
Prepare an owner-specific review queue.
Document specialists approve classifications and resolve findings.
Ready to review
TMF quality review queue
- Suggested classification and metadata
- Completeness exceptions
- Source-linked remediation tasks
Pilot measureReviewer time per document or resolved exception
Put the evidence beside the claim.
Bring promotional content, references and market requirements into one review for life sciences teams. Prepare findings for medical, legal and regulatory reviewers.
Promotional items · References · Market requirements
Retrieve
Gather the relevant references.
Check
Compare claims and required information.
Prepare
Organize findings for expert review.
Medical, legal and regulatory reviewers make approval decisions.
Ready to review
Promotional content review package
- Claim-to-reference mapping
- Potential issues by review discipline
- Draft comments with source links
Pilot measureTime spent preparing and triaging each review
Customize agents to fit your work.
Adapt existing agents or build new ones around your SOPs, systems and study requirements. Our engineers work with you to connect the data, define handoffs and set the review steps.
Your SOPs · Existing systems · Study requirements · Access policies
Tasks
Set each agent’s role, instructions and handoffs around your SOPs.
Context
Connect approved sources, tools and study context.
Controls
Define access boundaries, review gates and escalation rules.
Your process owners approve the workflow and decide which actions need human review.
Built with your team
Your custom workflow
- Adapted or purpose-built agents
- Connected systems and evidence
- Defined permissions and review steps
Pilot measureTime, output quality and rework against your baseline
A GxP-ready
foundation.
Build on a platform designed for regulated workflows. We make the deployment, validation, monitoring, and ongoing maintenance simple.
Boundaries that follow the work
Permissions shaped by sponsor, study, role and purpose. Privacy and residency requirements that account for the data, patient population and market.
Evidence behind every handoff
Source-linked outputs, versioned records, audit trails and e-signature approvals. A clear record of what an agent proposed and what a person decided.
Change you can control
Pinned models, controlled workflow versions and validation evidence. Define how a change is assessed, tested and approved before it reaches regulated work.
Deployment on your terms
Designed for your environment, with Veeva and other existing systems in the workflow. Scope GDPR and jurisdiction-specific requirements to the intended use.
We find the bottleneck,
and build the workflow.
Our forward-deployed engineering approach starts with the work: the systems, the SOPs, the people and the point where time is lost.
Map
Choose the workflow and its boundaries.
Build
Connect the data. Coordinate the agents.
Measure
Review quality, effort and turnaround.
Agents built for your team.
A team trained to use them.
We design agents around your team’s SOPs, systems and responsibilities. Hands-on training shows people how to use the agents in daily work, review outputs and handle exceptions.