Development Plans
Milestones, dependencies, assumptions
AI-native clinical development
Keep the path from molecule to clinic connected.
CadenceAI is the AI-native clinical development agent that thinks alongside your team, connecting development plans, regulatory milestones, vendors, contracts, sites, invoices, and spend into one continuously updated view of your program.
AI NativeBuilt for how you workEvidence BackedSourced and auditableControlled WorkflowsBuilt for Part 11 workflowsEnterprise ReadyCloud native and scalable
Scenario impactIllustrative view
Current planAug 28first patient in
Updated forecastSep 173 weeks later
Forecast impact+$420Kcontracts and sites
What moves nextA CRO amendment changes site startup and the first patient in forecastScenario 01
TriggerCRO amendment adds six weeks to site startup
Why this changed3 sources
FactCRO amendmentApproved scope change
AssumptionActivation sequencePending team review
ActionValidate budget impactRecommended next step
One connected view across your development program
Regulatory
Submissions, commitments, interactions
Vendors
CROs, CDMOs, labs, consultants
Contracts
MSAs, SOWs, amendments, deliverables
Sites
Startup, activation, enrollment
Financials
Budgets, invoices, accruals, forecasts
Pipeline Visibility
Portfolio status, risks, decisions
On the roadmap
Ask your program a question
Where we are taking the program model next: questions answered with context, evidence, and recommended actions. Available today: the evidence-backed program view and deterministic conflict detection behind it.
Can we still dose our first patient by August 28, 2027?
Current forecast is September 17, 2027 with medium confidence.
What threatens our IND submission date?
Two prerequisites are at risk across CMC and nonclinical work.
What does this CRO amendment change?
It adds $420K and six weeks to site startup, affecting first patient in.
Which sites are putting enrollment at risk?
Two sites are more than 15 percent behind target enrollment.
How does this delay impact our budget?
Forecasted impact is $1.2M and eight weeks to first patient in.
Programs and platform
NVIDIA Inception
Member
Microsoft for Startups
Member
Claude Partner Network
Member
Microsoft Azure
Cloud infrastructure
21 CFR Part 11
Built for Part 11 workflows
Program memberships, not endorsements or investments. CadenceAI is built to support 21 CFR Part 11 workflows, including audit trails, access controls, and electronic signatures. Sponsors validate compliance for their own implementation. Nothing autonomous acts on customer documents; every extraction is reviewed by a person before it is treated as fact, and dates and financial calculations are deterministic rather than generated by a model.
Free planner
Plan it before you control it.
Enter your program modality, workstream status, and target first dose date. The planner maps what would need to be underway and compares seven regulatory routes. Every assumption is shown, sourced, and editable.
FreeNo loginAbout 2 minutesBeta
Check your first dose dateBuilt from statutory timelines, reported agency metrics, and fifteen years of sponsor side program management. Not regulatory advice.The target conflicts with the entered assumptions
Four activities would already need to be underway: GMP manufacture, GLP toxicology, CRO selection, and protocol finalization.
Better to know today than at the bid defense.
The difference
Disconnected trackers vs. a living program model
Clinical development is connected. CadenceAI gives teams one evidence-backed view of what is happening, what is at risk, and what needs attention.
Today
- ✕Plans, regulatory work, vendors, sites, and spend live in separate tools
- ✕Knock-on effects surface after decisions are already made
- ✕Assumptions and source evidence are scattered across files and teams
With CadenceAI
- One asset-centered model connects the whole development program
- Changed prerequisites surface against the milestones that depend on them
- Execution, spend, assumptions, and evidence stay linked
How it works
From scattered program inputs to connected decisions
CadenceAI builds a living model of the asset and reasons across the changes that move development forward.
1
Bring the program
Plans, agency feedback, contracts, site plans, invoices, and reports
2
AI connects
Milestones, dependencies, obligations, spend, assumptions, and evidence
3
Reason across change
See what changed, what it affects, and what becomes critical
4
Act with evidence
Make program decisions with the source and reasoning visible
What you get
One program model across the work that moves an asset forward
Built for the operating reality of emerging biotech, from development strategy to the clinic.
Development planning & dependencies
See what has to be true to reach the next milestone
- Connect CMC, nonclinical, regulatory, and clinical dependencies
- Trace every finding back to the document it came from
Regulatory, vendor & site execution
Keep the work around the asset connected as it moves
- Link commitments, SOWs, sites, deliverables, and obligations
- Surface execution risk in the context of the program
Financial & evidence intelligence
Connect spend to the work, contracts, and evidence behind it
- Reconcile invoices and accruals to operational reality
- Keep facts, assumptions, and source evidence reviewable
From our founder
"Clinical development teams run one connected program through disconnected tools. We built CadenceAI so the plan, execution, spend, assumptions, and evidence can finally move together around the asset."
Tomas VanAdvisor
Built by clinical development operators, with the teams responsible for moving assets from strategy to the clinic.
Bring one real development question.
Bring one asset, timeline, SOW, regulatory milestone, site plan, or invoice. We’ll show how CadenceAI connects it to the development program.