The clinical trial systems landscape.
A working map of the systems that run a clinical trial — from study setup through regulatory submission. Internal trial systems, vendor platforms, and external regulatory interfaces, organized by phase.
Sponsors, CROs, and vendors all operate inside the same picture but play different roles. This map describes the systems and their integration points; the operating-model note at the foot addresses who runs what, and who carries the validation responsibility.
Internal trial system
Sponsor-controlled. CTMS, ETMF, EDC, IRT, eCOA, etc.
Vendor platform
Commercial third-party software, swappable by procurement.
External regulatory
FDA, ClinicalTrials.gov. Legal authority, mandatory interfaces.
CTMS
Study planning, site management, timeline tracking
ETMF
Regulatory document management, approvals
IRT
Randomization setup, drug supply planning
Site selection & feasibility
ZS Zaidyn
AI analytics for site identification and planning
Phesi
Trial-database-driven feasibility, enrollment forecasting
Protocol optimization
Trials.ai
Protocol optimization, eligibility modeling
Faro Health
Structured digital protocol authoring
Intelligencia AI
AI for protocol design, indication selection
Regulatory interfaces
ClinicalTrials.gov
Trial registration, protocol updates
FDA / Regulatory
IND submissions, protocol approvals, safety reporting
CTMS
Screening tracking, site coordination
IRT
Randomization, treatment assignment
EDC
Baseline data entry, screening forms
Patient recruitment
Deep 6 AI
EHR-based patient finding, eligibility matching
Inato
Site discovery and patient matching marketplace
Antidote
Patient-facing recruitment, pre-screening
Regulatory interfaces
ClinicalTrials.gov
Enrollment status updates, recruitment milestones
CTMS
Visit scheduling, monitoring oversight
eCOA
Clinician-reported outcomes, assessments
ePRO
Patient-reported symptoms, QoL diaries
EDC
Clinical data, lab results, adverse events
Safety DB
Pharmacovigilance, SUSAR processing
RBQM
Risk analytics, quality monitoring
Decentralized trial platforms
ProofPilot
Decentralized trial design and execution
Medable
DCT platform, eCOA, televisit integration
Central lab & imaging
LabConnect
Central laboratory services, specimen management
Calyx
Medical imaging, DICOM workflow, endpoint review
Regulatory interfaces
FDA / Regulatory
Expedited SAE / SUSAR reporting, 7-day and 15-day timelines
CTMS
Performance metrics, milestone tracking
RBQM
Risk-based monitoring, targeted SDV
ETMF
Inspection-readiness, document completeness
Site payments
Greenphire
Site and patient payment automation
Quality management
Veeva Vault QMS
Deviations, CAPA, quality oversight
MasterControl
Quality and document control, validated workflows
Regulatory interfaces
ClinicalTrials.gov
Status updates, milestone reporting
Submission pipeline
EDC
Database lock, final extract
SAS
SDTM / ADaM creation, statistical analysis
Pinnacle 21
CDISC validation, FDA business rules
DocuBridge
eCTD assembly, submission package
FDA ESG
Electronic submission gateway
Regulatory interfaces
FDA Review
Application review, approval decision
ClinicalTrials.gov
Public results posting, final disclosure
Who runs what — and who is accountable.
The sponsor holds ultimate regulatory accountability for the trial — including the validated state of every supporting system — regardless of who operates them. In Functional Service Provider (FSP) engagements, CROs operate sponsor systems under the sponsor's QMS; in full-service engagements, the CRO brings its own platforms and QMS, and the sponsor discharges oversight through vendor audits and qualification evidence. Vendors validate their software to GAMP 5 supplier standards; sponsors perform Performance Qualification for their specific operational context. Throughout, the sponsor remains the regulatory party of record.
ServoSoft engagements often start at exactly these seams — where sponsor, CRO, and vendor responsibilities meet, and where the validation paperwork has to hold up under inspection. Get in touch if that sounds like the shape of your problem.