Each handoff rebuilds the evidence story.
Teams receive documents and outputs without the assumptions, definitions, unresolved questions, decisions, and source context required to use them efficiently.
Cross-functional evidence operations
Make evidence work as one operating system.
StromaOS connects knowledge management, evidence generation planning, decision packages, commitments, governance, cross-functional execution, and lifecycle handoffs in one shared operating environment.
Shared evidence context
Connected commitments and gaps
Governed cross-functional execution
Persistent organizational memory
The cross-functional operating problem
The highest-value evidence work sits between systems and functions.
Discovery, clinical, safety, regulatory, HEOR, market access, medical affairs, and quality often answer connected questions using separate repositories, vocabularies, timelines, tools, review models, and decision records.
Evidence commitments are managed outside the decisions they support.
Studies, analyses, experiments, reports, submissions, market commitments, and follow-up actions are tracked in separate planning systems and local spreadsheets.
The organization remembers artifacts, not reasoning.
Why a decision was made, which evidence was rejected, what uncertainty remained, who disagreed, and what happened afterward are difficult to retrieve and reuse.
Each function governs AI and execution differently.
Independent pilots, agents, models, tools, and internal applications create inconsistent controls for data, methods, quality, human authority, release, and traceability.
How the solution works
Cross-functional work becomes one governed question-to-memory chain.
StromaOS coordinates evidence questions, shared context, work plans, domain execution, quality gates, accountable decisions, commitments, downstream actions, and organizational memory.
STEP 01
Frame the evidence question
Decision, claim, gap, risk, commitment, study, analysis, market need, or lifecycle issue.
STEP 02
Assemble shared context
Sources, definitions, prior work, decisions, assumptions, gaps, commitments, owners, and deadlines.
STEP 03
Plan the work
Studies, analyses, experiments, workflows, dependencies, milestones, evidence standards, and review authorities.
STEP 04
Execute across functions
Domain agents, methods, tools, systems, quality gates, exception routing, and accountable human review.
STEP 05
Decide and commit
Decision package, approvals, actions, owners, downstream effects, commitments, and next evidence.
STEP 06
Preserve and reuse
Evidence, versions, rationale, dissent, outcomes, lessons, and reusable lifecycle context.
Lifecycle continuity
Evidence and decisions carry forward instead of restarting at each stage.
StromaOS preserves shared meaning while allowing each function to extend the evidence under its own standards, methods, policies, and authority.
One approved cohort serves many functions. HEOR, safety, medical writing, clinical operations and market access receive the same versioned population by reference rather than each rebuilding it.
STAGE 01
Discovery
Mechanism, target, translation, risk, portfolio rationale, gaps, and evidence hypotheses.
STAGE 02
Preclinical
Translational evidence, safety, exposure, readiness, unresolved risk, and planned work.
STAGE 03
Clinical
Protocols, endpoints, studies, operations, MIDD, safety, decisions, and cross-study learning.
STAGE 04
Regulatory
Claims, evidence packages, submissions, questions, commitments, approvals, and responses.
STAGE 05
Launch & access
Value evidence, payer needs, medical questions, local adaptation, and market commitments.
STAGE 06
Lifecycle
Safety, RWE, quality, label, market learning, evidence gaps, and lifecycle optimization.
Evidence operations control
See the work, the gaps, the decisions, and the consequences in one place.
StromaOS does not replace every specialist system. It creates the shared operating layer that connects those systems through common entities, evidence questions, workflow states, decisions, commitments, risks, milestones, and authority.
Leadership can review program and portfolio readiness without flattening the underlying scientific and functional detail.
Model an evidence operating review
Governance across functions
One Governance Spine can preserve different functional authorities.
StromaOS applies a common execution architecture while keeping scientific, clinical, safety, regulatory, quality, market, medical, and portfolio decision rights separate.
Explore the Governance Spine01
Shared semantic governance
Common entities, definitions, ontologies, classifications, lineage, and temporal context allow functions to work from consistent meaning without forcing identical applications.
02
Purpose and authority boundaries
Role, purpose, function, program, data class, jurisdiction, workflow state, model, tool, action, approval, and release permissions are evaluated before execution.
03
Cross-functional quality gates
Evidence sufficiency, method validity, reproducibility, completeness, confidence, unresolved uncertainty, dependency, and required review govern progression.
04
Human authority by function
Scientific, clinical, safety, regulatory, quality, economic, medical, and portfolio authorities remain distinct and accountable even inside shared workflows.
05
Evidence Data Trace
Sources, transformations, methods, prompts, models, versions, policies, decisions, approvals, commitments, actions, outcomes, and reuse remain reconstructable.
Start with one cross-functional decision, evidence plan, or lifecycle handoff.
Connect the systems and evidence already in use. Define the shared context, functional authorities, quality gates, commitments, owners, and decision record. Then run the work as one governed evidence operation.