Study & site operations
Studies, countries, site selection, startup prerequisites and protocol amendments in their operational context.
Plan the study
Clinical trial management software
Your study.
Your sites.
Connected.
Spence connects clinical operations, essential records and site finances in one CTMS—bringing the work, the people and the evidence together.
The steward of your trials.
spence / clinical operationsIllustrative product view
STUDY / SPX-201
Study operations
The right next action. The evidence behind it.
12PARTICIPATING SITES
03READINESS ACTIONS
08REVIEW TASKS
Site 004 · Ethics approvalCoordinator → Quality reviewer
Review needed
Monitoring follow-upCRA → Site investigator
Response due
Site 002 · Invoice reconciliationVerified activity → Finance
Ready
Synthetic illustration of the product direction—not a screenshot or live study.
✓ Exact-version evidence. Accountable next steps.
CTMSeTMF / eISFSite startupMonitoring & qualitySite finances
SPENCE
Your operations. Your evidence.The steward of your trials.
A connected clinical trial.
One connected clinical operations platform
Manage the trial.
Keep the whole picture.
From the first site assessment to closeout, Spence is being built to connect operational decisions with their owners, dependencies and supporting records.
Participants & visits
Coded participant tracking, consent status and scheduled, completed or missed visit workflows.
Coordinate visits
eTMF & eISF workflows
Expected evidence, document versions, review, annotations and controlled sharing linked to the study.
Connect the evidence
Monitoring & quality
Monitoring reports, findings, deviations and corrective work with accountable review.
Follow through
Site budgets & finances
Date-effective rates, verified activities, invoices and recorded payment reconciliation.
Reconcile activity
Training & responsibilities
Assignments, protocol-related training and delegation evidence supporting site readiness.
Prepare the team
Study & site operations
Studies, countries, site selection, startup prerequisites and protocol amendments in their operational context.
Participants & visits
Coded participant tracking, consent status and scheduled, completed or missed visit workflows.
eTMF & eISF workflows
Expected evidence, document versions, review, annotations and controlled sharing linked to the study.
Monitoring & quality
Monitoring reports, findings, deviations and corrective work with accountable review.
Site budgets & finances
Date-effective rates, verified activities, invoices and recorded payment reconciliation.
Training & responsibilities
Assignments, protocol-related training and delegation evidence supporting site readiness.
Built for the teams running the trial
One platform.
Three working perspectives.
CRO operations
Coordinate the study.
Follow through at every site.
Bring startup work, monitoring follow-up, quality actions and financial records into a connected operational workspace.
- See readiness blockers and accountable next actions.
- Connect CRA findings to site responses and evidence.
- Follow activity through invoice and reconciliation.
CRO WORKSPACE / CONCEPT
From exception to action.
Startup prerequisite missingSite coordinator · evidence request
AssignedMonitoring finding respondedIndependent Quality review
Next stepInvoice allocation readyFinance · outstanding balance
ReconcileSite operations
Less searching.
A clearer next step.
A site-focused experience for investigators and coordinators, connecting everyday trial work with the records and responsibilities behind it.
- Work through startup and training requirements.
- Track coded participants, visits and follow-up.
- Respond to monitor queries with exact-version evidence.
SITE WORKSPACE / CONCEPT
Today at your site.
Protocol amendment trainingCoordinator · review assigned version
Due todayParticipant visit follow-upCoded participant · confirm next appointment
ScheduledMonitor query responseInvestigator · link corrective evidence
Response dueIllustrative workflow with synthetic examples.
Sponsor oversight
Oversight with context.
Evidence with boundaries.
Follow authorized study progress, commitments, risks and delivered records without treating every organization's information as one shared folder.
- Review permitted milestones and outstanding exceptions.
- Receive and reconcile exact-version evidence.
- Respect independent site and CRO custody.
SPONSOR WORKSPACE / CONCEPT
Visibility where it matters.
Study milestoneSite readiness · authorized status
AttentionEvidence releaseExact version · receipt distinct from acceptance
ReceivedQuality exceptionPermitted risk and resolution status
ReviewDifferent responsibilities. A connected study.
For the people
behind the trial.
FOR CROsConnect the team.
Connect the team.
Coordinate the study.
Study oversight, site startup, monitoring and financial follow-through.
Explore CRO operations ↗
FOR RESEARCH SITESKeep site work
Keep site work
moving forward.
Team readiness, visit coordination, essential records and monitor responses.
Explore site operations ↗
FOR SPONSORSFollow progress.
Follow progress.
Understand the evidence.
Authorized milestones, study exceptions and controlled evidence delivery.
Explore sponsor oversight ↗DOCUMENT WORKSPACE / ILLUSTRATION
STUDY RECORD · VERSION 2
Monitoring report
Review with a traceable history.Version · meaning · execution time · signature reference
Synthetic signing demonstration. Not for regulated use.
Records that belong to the workflow
More than a place
to upload files.
Connect essential records to startup, training, monitoring and quality. See the version under review, the questions that need answering and the evidence supporting the next decision.
Spence's document foundation includes versions, QC, annotations and synthetic signing with downloadable signature pages. Full archive, storage and live-use qualification remain work in progress.
See the document journey ↗From startup to financial follow-through
The handoff is part of the product.
A connected workflow keeps the next actor, the prerequisite and the evidence in view.
01 / PREPAREAssess & activate
Site assessment, readiness tasks and evidence-linked activation.
02 / OPERATECoordinate & track
Coded participants, visit status and team responsibilities.
03 / OVERSEEMonitor & resolve
Findings, responses, corrective evidence and review.
04 / RECONCILEVerify & account
Eligible activity, payable records, invoices and allocations.
Security & transparency
Trust needs evidence.
Our stewardship promise means being clear about controls, limitations and responsibilities. Spence remains a protected synthetic-data prototype, with real regulated signing disabled.
No blanket compliance or certification claimsIdentity & accessIndividual accounts with password + one-time code, offboarding, recorded recovery and scoped access.
Electronic signaturesSynthetic password + OTP signing and manifestations.
Continuity & recoveryIsolated restore exercises, including authenticator-key recovery; hosted-provider restore and RPO/RTO not yet proven.
Validation & privacyIQ/OQ/PQ evidence and GDPR/HIPAA applicability tracked separately.
Spence / The steward of your trials
See how your study's
work could connect.
Explore clinical operations, essential records and site finances in the protected synthetic preview.
Enter your email to receive a four-digit code for a read-only synthetic demo. Customers sign in with their own account.