One trial. Three organizations. No operational blind spots.

TrialScale connects sponsors, CROs, and investigative sites around shared study execution—bringing startup, monitoring, site activity, payments, and risk signals together across the clinical systems you already use.

See TrialScale in action Explore the operating model

Adopt without disruption.

Works alongside CTMS, EDC, eTMF, RTSM, safety, and data platforms—or takes ownership of fragmented workflows as your program evolves.

A single operational event, carried throughEXAMPLE WORKFLOW

Investigative site

SITE-128

A protocol visit is completed and the verified record is available for downstream operational review.

TrialScale operational layer

RULES + CONTEXT

Visit status, monitoring context, and milestone eligibility stay connected instead of becoming separate reconciliation tasks.

Sponsor & CRO

ACTION QUEUE

The team sees the current operational state in one place, including the next monitoring or financial action that requires attention.

Illustrative workflow based on TrialScale capabilities; not a customer result.

FDA 21 CFR Part 11 readyEU Annex 11 alignedGAMP 5 Category 4 principlesTLS 1.3 & AES-256 encryptionHIPAA BAA eligible

Same trial. Different jobs to do.

Sponsors and CROs need portfolio-level risk and execution context. Site teams need a focused view of what requires action today. TrialScale gives each role the right interface without breaking the shared operational record.

Sponsor Clinical Trial Manager (CTM) Command Center

Global oversight: Protocol ONC-302 • 12 Countries • 48 Sites • 420 Subjects

Simulated Study PreviewExport Audit Trail (preview)

Site Risk & Milestone Matrix

Simulated Data • Sorted by KRIs

Site	Institution	Enrollment	KRI Status	Trip Report	Status
SITE-101	Metro Oncology Research Center	18 / 20 (90%)	0.08 Low	Approved	Activated
SITE-104	Regional Cancer & Clinical Institute	22 / 20 (110%)	0.11 Low	Signed	Activated
SITE-112	European Clinical Center - Site Berlin	12 / 15 (80%)	0.42 Medium	Due in 2d	Review Req
SITE-128	Pacific University Clinical Center	5 / 15 (33%)	0.78 High	Overdue	Targeted Audit

Monitoring Visit Reports (MVRs)

IMV Report #3 - Site 101

CRA: J. Martinez • 0 open issues

Sign Off

COV Report - Site 094

CRA: E. Lind • IP reconciliation ready

Review

Milestone Disbursements

$184,500 Auto-Queued

14 Verified patient visits

Batch Pay

Workflows move when context does.

TrialScale is not a pile of disconnected modules. The same operational context can carry from startup through monitoring, site execution, finance, and inspection readiness.

Explore all capabilities

Study startup

Keep feasibility, investigator packages, IRB/IEC dependencies, and site greenlight status in the same execution path instead of reconciling trackers after the fact.

Feasibility → documents → approvals → activation

Monitoring & RBQM

Use site-level key risk indicators and quality tolerance limits to surface where review is needed, while keeping monitoring reports and follow-up actions connected to study context.

Signals → targeted review → action → traceability

Site payments

Connect verified study activity to milestone eligibility and site financial ledgers so payment administration does not become a separate manual reconciliation exercise.

Study activity → milestone verification → payable workflow

Electronic records

Support controlled electronic signatures, reason-for-change capture, and audit trails without treating compliance as a separate layer bolted onto the workflow.

Identity → signature → audit trail → review

Clinical systems integration

Coexist with established CTMS, EDC, RTSM, eTMF, safety, and data platforms through open REST/CDISC data exchange rather than forcing a rip-and-replace program.

Adopt where the gap is greatest. Expand when it earns the work.

Validation evidence should travel with the platform.

TrialScale is architected around FDA Computer Software Assurance and GAMP 5 Category 4 risk-based approaches so QA teams can evaluate controlled records, verification evidence, and system changes without rebuilding the validation story from scratch.

Continuous traceability

Requirements-to-test mapping maintained through automated testing and continuous integration.

Verification protocols

Standardized test scripts and qualification procedures intended to accelerate internal IQ/OQ validation.

Security & privacy controls

Role-based access control, encrypted data at rest and in transit, and HIPAA BAA availability for PHI protection.

21 CFR Part 11 architecture

Cryptographic audit trails, controlled electronic signatures, identity verification, and reason-for-change capture.

Request the CSA & GAMP 5 architecture brief

A technical guide for QA and clinical operations leaders covering risk-based testing, data integrity controls, and qualification strategy.

Built for clinical operations that must survive scrutiny.

TrialScale is designed around the practical reality of clinical work: multiple organizations, established systems, regulated records, and operational handoffs that still too often fall back to spreadsheets and email.

Connect without forcing replacement

Start with the workflow where operational friction is highest. TrialScale can integrate with established CTMS, EDC, eTMF, safety, and data platforms, then take on more responsibility as the program evolves.

Engineer compliance into the workflow

The platform is designed to support FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 principles with controlled electronic records, cryptographic audit trails, and automated verification.

Work directly with the product team

Design partners work directly with product engineering to map active protocols, operational workflows, and integration requirements into the platform.

Early-adopter design partner program

A focused engagement for biopharma sponsors and CROs that want direct influence over how TrialScale supports real protocol execution.

Discuss a design partnership

Model your assumptions, not ours.

Use the estimator as a planning model for startup, monitoring, and payment administration. The operating assumptions are editable so the output reflects your study economics rather than a claimed customer benchmark.

Active clinical sites35 sites

5150

Target enrolled subjects350 subjects

201,500

Protocol duration18 months

648

Adjust planning assumptions

Startup days saved

Value per startup day ($)

Monitoring hours saved / site-month

Loaded monitoring hourly cost ($)

Payment admin saved / site-month ($)

Payment admin saved / subject ($)

Illustrative portfolio estimate

Startup time modeled

Directly from your assumption

30 days

Monitoring labor modeled

Sites × months × hours saved

1,260 hours

Payment administration modeled

Site-month + subject assumptions

$231,000

Estimated total modeled impact

$456,000

Planning model only. This is not a quote, forecast, benchmark, or measured customer result. Validate every assumption against your study design, internal labor model, and accounting practices.

See where TrialScale fits.

Bring the workflow, handoff, or system gap that creates friction today. We’ll map the problem across the organizations and systems involved, then show where TrialScale could take ownership without forcing a rip-and-replace program.

A workflow that keeps falling back to email or spreadsheets

Startup, monitoring, site coordination, payments, or another operational handoff.

A gap between organizations or systems

Where sponsor, CRO, and site teams do not share the same current operational state.

A question about fit

You do not need a defined implementation plan to start the conversation.

Prefer to book directly?Reserve time via Cal.com/trialscale.

Start with the problem.

Name, work email, and organization are enough to start. Add the workflow or systems involved only if it helps us make the first conversation more useful.