Sponsors
Oversight, CRO execution, amendment impact, safety context, and inspection readiness stay tied to the record.
Platform overview
One study record across the clinical stack.
Clinistack connects clinical operations, documents, data capture, randomization, patient work, payments, safety, integrations, and AI review around the same study record. Teams see the work they own, the source behind it, and the evidence that explains each decision.
Product Workspaces
Role-specific surfaces where teams run the work without splitting the study record.
Examples: CTMS, eTMF, EDC, RTSM, payments, PV, patient work, and AI review.
Common Study Spine
The shared study context that keeps operational, document, data, and safety work connected.
Examples: protocol, sites, subjects, visits, amendments, milestones, and evidence links.
Platform Controls
Cross-suite controls that make regulated actions traceable, permissioned, and reviewable.
Examples: tenancy, DAC, audit chain, e-signatures, WORM documents, workflow, and AI Data Contracts.
Governed Exchange
Controlled movement between source systems and Clinistack with reviewable mapping and release evidence.
Examples: APIs, HL7/FHIR, ODM, USDM/M11, validation, exceptions, and release history.
Source Systems
Systems and records that feed the trial context while preserving source ownership.
Examples: EDC, eTMF, CTMS, RTSM, safety, labs, EHR/source, identity, and spreadsheets.
Study record
The study changes everywhere at once.
A protocol update can affect startup, consent, EDC, TMF, monitoring, safety, training, and site work. Clinistack keeps those changes tied to one study context instead of letting each system tell a different story.
CROs
Repeatable delivery can still preserve Sponsor requirements, country variation, and client-visible evidence.
Sites and biotech teams
Sites get fewer duplicate requests. Lean Sponsors get portfolio signal without rebuilding status from vendor reports.
Suite map
Trial events should update the rest of the trial.
Activation, amendment, monitoring, document filing, randomization, patient input, payments, and safety work all change the same study. Clinistack lets those events update the work around them.
Activation to inspection
Study setup, delegation, training, documents, completeness, access, and inspection proof stay connected.
Data to decision
EDC review, RTSM access, patient input, labs, monitoring, safety signals, and AI review stay in context.
Finance and safety with context
Milestones, accrual, vendor work, PV intake, coding, and signal review remain tied to the study.
Inspection routine
Make inspection day feel routine.
When the question is show me, the answer should already be in the record. Clinistack ties state changes, denials, signatures, document versions, AI suggestions, integration runs, and inspection reads to the trail teams need.
Audit and access
Denials, sensitive reads, break-glass use, role changes, and integration writes leave clear traces.
Documents and signatures
WORM content, supersession, signature meaning, record hash, timestamp, and signer identity stay with the evidence.
Automation and inspection
AI helps classify, summarize, compare, and route while reviewer decisions, effective records, lineage, and audit context stay inspectable.
Rollout
Start where the trial is under pressure.
A serious rollout starts with the study, portfolio, source systems, and evidence questions that are already creating operational heat.
Start with a study or portfolio
Start with activation, eTMF completeness, inspection readiness, system exchange, or AI review first.
Keep record ownership clear
Clinistack does not need to replace every system before it can organize clinical work around them.
Expand by workflow
Add CTMS, eTMF, EDC, RTSM, patient, financial, and PV workstreams as the trial workflow expands.
First rollout
Bring the study question your team keeps rebuilding.
We will review the product path, system context, owners, evidence, and rollout approach that fit the trial work in front of you.