Risk isn't a liability. It's the terrain.
Every CMC program crosses difficult ground. The teams that succeed aren't the ones that pretend the terrain is flat — they're the ones who map it early, score it honestly, and route around the cliffs. Summit treats risk as the strategic substrate of the program, not a register filed after the fact.
Identify risk early. Build realistic plans. Prepare for the climb. That's how odds of success move.
Risk is terrain, not failure.
A high-risk program isn't a bad program. It's a program that needs a different route, different gear, and a different pace.
Mapped early, managed cheaply.
Risks identified at design cost weeks. Risks discovered at scale-up cost quarters. Summit pulls discovery forward.
Honest plans win.
Plans that acknowledge risk and budget for it land closer to reality than plans that promise certainty they can't deliver.
Scoring you can defend
A scoring engine your quality council actually agrees with.
Risk scoring shouldn't be a black box, and it shouldn't be three columns on a spreadsheet either. Summit ships configurable scoring models — severity, likelihood, detectability, criticality, residual — with bands and thresholds your team controls. Calibrate once. Score everywhere. Defend with evidence.
- Configurable dimensions, weights, and band thresholds per organisation
- Pre-mitigation and residual scoring tracked side by side
- Per-program overrides for modality-specific risk profiles
- Every score auditable to the assumption and assessor behind it
Each bubble is a live risk on the program. Upper-right is where the climb gets steep.
The risk map
Every risk on the program, on one chart.
Summit plots each live risk by likelihood and impact, with bubble size showing a third dimension — detectability, criticality, or whatever your council scores against. The upper-right quadrant is where the climb gets steep. Leaders see it instantly, long before a governance meeting forces the conversation.
- Two-axis view with configurable third dimension as bubble size
- Risks rolled up from activities, CPPs, CQAs, and liabilities — not entered twice
- Filter by modality, owner, or therapeutic area to find the real hotspots
- Click any bubble to drill into the underlying assumption, owner, and mitigation
Risk as strategy
Plans that name the risk land closer to reality than plans that hide it.
Every Summit timeline is built from activities that already carry their risk. When a residual score is high, the plan reflects it — more characterisation, a longer stability arm, an earlier engineering run, a parallel mitigation. Risk doesn't sit beside the plan. It shapes the plan.
- Mitigations bound to the activity that delivers them
- Residual risk re-scored automatically as evidence accumulates
- Scenario compare: same program, different risk appetites, side-by-side
- Governance-ready narrative — what we know, what we don't, how we're hedged
Risk lives on the activity
Instantiate an activity, inherit its risk.
In Summit, risk isn't a separate register people forget to update. Every activity template carries the risks the industry already knows it owns — aggregation, leachables, charge variants, HCP clearance. The moment a planner drops that activity into a program, those risks land on the program's register, pre-scored, owner-ready, and already wired to the mitigations that retire them.
- Activity templates ship with their canonical risk profile
- Instantiation copies risks onto the program, scoped and editable
- Mitigations stay bound to the activity that delivers them
- Update the template, and every future instance inherits the change
Across the platform
Risk intelligence everywhere it matters.
Risk register
One source of truth — every risk, owner, score, and mitigation linked to the activities that retire it.
Propagation engine
Liabilities cascade to CQAs, CPPs, activities, and timelines. Update once; the program reshapes itself.
Residual tracking
Watch residual risk fall as evidence accumulates — or rise when assumptions break.
Scenario compare
Same program, different risk appetite. Compare timelines, cost, and exposure side by side.
Org-level calibration
Set the scoring model your council agrees with — bands, weights, escalation thresholds, all in your control.
Governance narrative
Auto-assembled risk story for steering committees: what's red, why, and what we're doing about it.
Map the terrain. Pick the route. Climb prepared.
See how Summit would model the risk profile of one of your active programs.