Sponsor CTMS
Multi-study, multi-site management for pharma and biotech sponsors.
Clinical Trial Management
Clinical Trial Management
We build CTMS platforms that manage sites, subjects, and visits on FHIR ResearchStudy and ResearchSubject, with eConsent, EDC integration, and real-world evidence pipelines drawn from EHR data.
HIPAA-Ready21 CFR Part 11FHIR R4Audit Logged
Trusted by global innovators
What is clinical trial management software?
Clinical trial management software (CTMS) runs the operational side of a study: sites, participants, visit schedules, enrollment, milestones and monitoring. Agnotic Technologies builds CTMS platforms for sponsors, CROs and research sites, modeled on HL7 FHIR ResearchStudy, with eConsent, EDC integration and 21 CFR Part 11 controls designed in.
Modeled on FHIR ResearchStudy and ResearchSubject, trial data connects to the clinical world instead of living in spreadsheets and separate EDC systems.
eConsent makes informed consent a documented digital workflow, and real-world evidence pipelines pull de-identified EHR data through FHIR for feasibility and recruitment.
What it is
What does a CTMS manage in a trial?
A CTMS manages the operations of a clinical study (sites, subjects, visits, enrollment, and monitoring) as a single source of truth across every site and stakeholder.
A modern one goes further: eConsent for auditable digital consent, EDC integration for clinical data, and FHIR-based real-world evidence pipelines that connect the trial to EHR data, all under 21 CFR Part 11 controls.
How does trial data flow?
See how we connect FHIR ResearchStudy, eConsent, EDC, and real-world evidence pipelines across the trial platforms we build.
What goes into a CTMS platform?
Each capability ties a trial operation to the standard or regulation that keeps it credible.
FHIR ResearchStudy backbone
Study, site, subject, and visit data modeled on FHIR ResearchStudy and ResearchSubject so trial operations connect to clinical systems instead of living in isolation.
eConsent workflows
Digital informed consent with versioned forms, comprehension checks, e-signatures, and a full audit trail that satisfies 21 CFR Part 11 and IRB expectations.
EDC & case report forms
Integration with electronic data capture systems and structured CRFs so operational and clinical data stay reconciled across the study.
Real-world evidence pipelines
De-identified data extraction from EHRs over FHIR to power recruitment, feasibility, cohort discovery, and post-market real-world evidence.
Site & subject management
Enrollment tracking, visit scheduling, protocol deviations, and milestone monitoring across sites with role-scoped access for sponsors, CROs, and coordinators.
21 CFR Part 11 compliance
Electronic records and signatures, immutable audit trails, and validated system controls engineered in from day one, not retrofitted before inspection.
Where it runs
Which trial models do we build for?
CRO platforms
Contract research organization tools spanning many client studies.
Site / SMO systems
Coordinator-facing tools for study conduct at research sites.
Decentralized trials
Remote enrollment, eConsent, and telehealth-integrated visits.
Registries & post-market
Long-run observational studies and post-market surveillance.
Recruitment & feasibility
EHR-driven cohort discovery to accelerate enrollment.
How do we build for inspection readiness?
CTMS fails when compliance and data integration are afterthoughts. We build Part 11 controls and FHIR pipelines in from the start.
FHIR R4
ResearchStudy & ResearchSubject modeling
Part 11
Electronic records & signatures
RWE
EHR-sourced real-world evidence
Compliance-First Healthcare App Development Services Backed by Global Standards
15-Minute Scoping Call01
HIPAA
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
02
GDPR
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
03
FHIR
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through standards-based FHIR APIs.
04
HL7
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
05
HITRUST
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
06
HITECH
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
07
SaMD
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
08
MDR (EU)
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
09
SAMHSA
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Standards we build against
Which research standards do we build against?
FHIRPart 11CDISCGCPHIPAA
Our Process
How do we ship a trial platform?
Operational data, consent, and evidence pipelines are built together under Part 11 controls so the platform is inspection-ready.
1.
Discovery & protocol mapping
We map the protocol, site model, visit schedule, and regulatory requirements, and design the FHIR ResearchStudy data model before building.
Protocol-first design
2.
Site & subject core
We build enrollment, visit scheduling, and monitoring with role-scoped access for sponsors, CROs, and coordinators.
Operational spine
3.
eConsent & data integration
We build eConsent workflows and integrate EDC and EHR-sourced RWE pipelines, validated against real study data.
Evidence-ready
4.
Validation & go-live
21 CFR Part 11 validation, audit-trail verification, and phased rollout with enrollment and data-quality dashboards.
Inspection-ready
Facts and sources
Which rules shape trial software?
Short facts we design around, each linked to its primary source.
21 CFR Part 11 sets FDA's requirements for electronic records and electronic signatures, including secure, computer-generated audit trails.
Source: 21 CFR Part 11 (eCFR)FDAAA 801 and its final rule require registration and results reporting for applicable clinical trials on ClinicalTrials.gov.
Source: ClinicalTrials.govThe HIPAA Privacy Rule lets covered entities use or disclose health information for research with a waiver of authorization approved by an IRB or privacy board.
Source: 45 CFR 164.512(i) (eCFR)The HIPAA Security Rule requires administrative, physical and technical safeguards for electronic protected health information.
Source: 45 CFR Part 164 Subpart C (eCFR)
Featured case study
Read Case StudyLera Health: compliant women's health platform
Related proof of compliant delivery: on Lera Health we built the privacy-first data layer, consent flows, and auditable clinical workflows end to end: the same rigor around records, signatures, and de-identification that trial software demands.
Why Partner With Us
15-Minute Scoping CallWhy build your CTMS with Agnotic?
Trial software is regulated and data-heavy. We bring the FHIR depth and Part 11 discipline it requires.
Compliance-first by default
21 CFR Part 11 records, signatures, and audit trails designed into the platform from sprint one, not before an inspection.
FHIR & research data depth
FHIR ResearchStudy, EDC integration, and EHR-sourced RWE are our working ground, so your team isn't teaching us the domain.
Recruitment-aware delivery
Feasibility and cohort-discovery pipelines built to accelerate enrollment, the metric that decides whether a trial stays on schedule.
Built for sponsors & CROs
Role-scoped, multi-site architecture that fits how sponsors, CROs, and sites actually collaborate.
Frequently Asked Questions
Yes. When participant data includes protected health information, Agnotic signs a business associate agreement before any PHI is shared with our team.
Cost depends on scope: a focused site-and-subject management tool is far smaller than a full platform with eConsent, EDC integration, and RWE pipelines under Part 11 validation. We scope by number of studies, sites, and data integrations, then phase the build so an operational core delivers value before the evidence and compliance layers expand.
It depends on scope. An operational core for sites, participants and visits comes first; eConsent, EDC integration and validated Part 11 controls follow. Validation documentation is on the critical path, so we plan for it from the start and give you a timeline after the scoping call.
Buy when a commercial CTMS fits your standard operating procedures and study types. Build when you need decentralized-trial workflows, deep EHR/RWE integration, or a differentiated data platform that off-the-shelf systems handle poorly. Many sponsors combine a licensed EDC with a custom operational and evidence layer built around FHIR ResearchStudy.
We integrate with electronic data capture systems to keep case report forms reconciled, and pull de-identified clinical data from EHRs over FHIR for feasibility, recruitment, and real-world evidence. Modeling operational data on FHIR ResearchStudy is what makes those clinical connections clean rather than bespoke per site.
Yes. We build digital informed consent with versioned forms, comprehension checks, and e-signatures backed by a Part 11-compliant audit trail, plus remote enrollment and telehealth-integrated visits for decentralized trials. This lets studies enroll and consent participants without requiring an in-person site visit.
We build electronic records and signatures, append-only audit trails and access controls into the platform from the first commit, aligned to ALCOA+ data-integrity principles. Validation is owned by your quality team; we deliver the specifications and test evidence they need.
Yes. We scope the first release to one workflow, usually site, participant and visit management for one study, with Part 11 audit trails in place from the start. eConsent, EDC integration and real-world evidence pipelines follow in later releases.
AI tools help our engineers draft code and tests, but a person reviews every change, and it passes the same automated tests and security checks as any other code, with the test evidence your validation team needs. Which tools may see your code or data is agreed with you at the start.
Related Solutions
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Building a CTMS or research data platform?
Tell us your study model and data sources. We'll return a phased plan covering FHIR ResearchStudy, eConsent, EDC integration, and real-world evidence pipelines.
contact@agnotic.com
Partnerships
contact@agnotic.com