Clinical Trial Intelligence Layer

Clinical Intelligence for Study Execution

TrialAmicus transforms complex protocols into instant, cited guidance for CRCs, CRAs, and study managers, grounded in your actual study documents.

10×faster protocol answers
100%cited, traceable responses
24/7availability for your team
AI Protocol Chat — Study 2024-301
CRC
Visit 4 was out of window by 5 days. How will this impact Visit 5?
AI
Visit 5 must be scheduled from the actual date of Visit 4, not the originally planned date. The protocol defines the Visit 5 window as Day 56 ± 7 days from Visit 4. §6.3 Visit Schedule Protocol v3.1

Since Visit 4 occurred 5 days late, Visit 5 should now target Day 56 from the actual Visit 4 date, with the same ±7 day window applied. The deviation at Visit 4 should be documented as a protocol deviation and does not extend or reset the overall study timeline.
CRC
Can a subject continue aspirin during the study?
AI

Built for the clinical research ecosystem

Academic Research Sites
CROs & Sponsors
Site Management Orgs
Clinical Quality Teams
IRB & Regulatory Teams
The Problem

Clinical trials fail at the point of interpretation

Protocols are complex. Teams are distributed. Roles overlap. The gap between what a protocol says and what a team does is where risk lives.

Protocol Complexity

Modern protocols span hundreds of pages with intricate eligibility criteria, visit schedules, and procedure-specific rules that no team can hold in memory.

Execution Ambiguity

Teams make judgment calls in the moment, on eligibility, procedures, and deviations, without reliable, study-grounded guidance at the point of care.

Operational Drift

Processes evolve informally over time. Amendments get missed. Site-specific habits diverge from the protocol, quietly accumulating risk before anyone notices.

Monitoring Inefficiency

CRAs spend limited site visit time reconstructing context, chasing documentation, and re-explaining protocol requirements that should be self-evident.

Misinterpretation Across Roles

CRCs, CRAs, PIs, and sponsors read the same protocol differently. Without a shared interpretation layer, misalignment compounds across visits and sites.

The Common Thread

Each of these failures stems from the same root cause: clinical teams operating without a reliable interpretation layer between complex study documents and real-world decisions.

TrialAmicus is the answer

The interpretation intelligence that sits between your study documents and your team, delivering consistent, cited, role-aware guidance at every point of decision.

Protocol Complexity Execution Ambiguity Operational Drift Monitoring Inefficiency Role Misinterpretation
Core Features

Everything your study team needs,
in one intelligent layer

AI Protocol Chat

TrialAmicus turns clinical trial protocols into structured intelligence that study teams can interact with. It doesn't retrieve. It understands. Ask about eligibility criteria, visit windows, or deviation thresholds and get protocol-grounded answers with exact citations, built on a deep comprehension of your study's logic, not a keyword search.

Studies Dashboard

A centralized hub for all your active studies. Manage document versions, upload amendments, and track knowledge base status across your entire site portfolio.

Role-Based Access

Assign granular permissions by role: CRC, CRA, PI, or sponsor. Each stakeholder sees only what they are authorized to access.

Full Audit Trail

Every question asked and answer given is logged with timestamps, user identity, and the source document reference, ready for regulatory review at any time.

Document Ingestion

Upload protocols, amendments, IB documents, lab manuals, and ICFs. TrialAmicus parses and indexes them automatically, ready for instant querying.

Instant Onboarding

New team members get up to speed in hours, not weeks. TrialAmicus becomes the on-call study expert for every site, reducing training burden and errors.

How It Works

From document upload to intelligent answers

Simple to set up. Powerful from day one.

1

Upload Study Documents

Upload your protocol, amendments, and supporting materials. We handle parsing and indexing automatically.

2

Configure Your Team

Set up roles for CRCs, CRAs, PIs, and sponsors. Each user sees only what they're authorized to access.

3

Ask Anything

Team members query the AI in plain language. Responses are instant, cited, and traceable to your documents.

4

Track & Audit

Every interaction is logged. Export audit-ready records at any time for regulatory submissions or sponsor reviews.

Trust & Compliance

Built for regulated environments

Clinical research demands the highest standards of data security and regulatory compliance. TrialAmicus is designed security-first, from infrastructure to interface.

End-to-End Encryption

All study data encrypted at rest and in transit using AES-256.

Role-Based Access

Granular permissions ensure users see only what they're authorized to access.

Audit Trails

Immutable logs of every query and response, ready for regulatory review.

Isolated Deployments

Your data never trains shared models. Fully isolated per organization.

Get Started

Ready to transform your trial operations?

Learn how TrialAmicus can reduce burden, raise quality, and accelerate study timelines.