Clinical Trial Workflow Management
Configure protocol-specific pathways, visit schedules, and task routing without writing code.
CTDMS for Oncology & Precision Surgery
Clinical trial data,
Clinical trial data,
engineered for certainty.
Arch Clinical Analytics unifies protocol design, digital case documentation, and regulatory reporting into a single system built specifically for cancer research and precision surgery trials — from first-in-human through post-market surveillance.
PT-2291Neoadjuvant response reviewActive
PT-2288Surgical pathology uploadIn review
PT-227630-day post-op follow-upActive
PT-2251Adverse event reconciliationLocked
21 CFR Part 11 verifiedSignature captured 09:41
Auto-query resolvedForm CRF-118
Platform
One system for every stage of the trial record.
Purpose-built modules replace the spreadsheets, PDFs, and disconnected tools that slow down oncology and surgical research teams.
Digital Clinical Forms
Build validated CRFs with branching logic, edit checks, and real-time data capture at the point of care.
Case Documentation
Centralize surgical notes, imaging references, and pathology reports in a single patient record.
Research Analytics & Reporting
Live enrollment, response, and endpoint dashboards, exportable for DSMB and steering committee review.
Workflow Automation
Auto-generate queries, escalate overdue visits, and route sign-offs to the right role automatically.
Role-Based Security
Granular permissions by site, role, and study stage, with a full access audit trail.
Regulatory Documentation Support
Structured, submission-ready documentation aligned to ICH-GCP and FDA/EMA expectations.
Secure Clinical Data Management
Encrypted at rest and in transit, with validated backups and configurable retention policies.
Trial Lifecycle
Built around how oncology trials actually run.
Each phase carries its own data requirements. ACA moves the record forward without re-entry, translation, or version drift.
PHASE 0 — SETUP
Protocol & Site Build
Digitize the protocol into forms, visit windows, and eligibility logic before first patient in.
PHASE I — ENROLLMENT
Screening & Consent
Track eligibility, e-consent, and randomization with full source-data traceability.
PHASE II — CONDUCT
Case & Surgical Documentation
Capture treatment, imaging, surgical outcomes, and adverse events as they happen.
PHASE III — CLOSEOUT
Lock, Report & Submit
Reconcile queries, lock the database, and export regulatory-ready packages.
Product Sneakpeek
Every study, one live view.
Coordinators, PIs, and sponsors see the same data at the same time — enrollment pace, protocol deviations, and documentation status, updated as records are entered.
- Site-level and study-level rollups, side by side
- Configurable alerts for overdue visits and open queries
- One-click export to CSV, PDF, or CDISC-aligned formats
Endpoint Tracking — Response Rate
ITT population, n=312
— Objective response
- - Progression-free
Research Analytics
Answers, not exports.
Build cohort comparisons, survival curves, and safety summaries directly against live trial data — no separate statistical pull, no version mismatch between the source record and the report.
- Custom cohorts by stage, arm, or biomarker status
- Scheduled reports for DSMB and IRB reviews
- Full audit history behind every figure
Security & Compliance
Built to the standard clinical data demands.
Every record, signature, and export is traceable — designed for environments where data integrity is inspected, not assumed.
Role-based access control
Granular permissions scoped to study, site, and role, reviewed on every login.
Encryption in transit & at rest
AES-256 storage encryption and TLS 1.3 for every connection to the platform.
Full audit trail
Every field edit, signature, and export is timestamped and immutable.
21 CFR Part 11 alignment
Electronic signatures and record controls built for regulated research.
Validated infrastructure
Hosted on infrastructure maintained under a documented validation lifecycle.
Configurable retention
Data retention and archival policies configured per sponsor and jurisdiction.
Why Choose Us
Why Choose Arch Clinical Analytics?
Arch Clinical Analytics was built by healthcare technology experts with decades of combined experience in clinical research, regulatory compliance, and healthcare IT. We understand the unique challenges of managing complex clinical trials.
Our platform combines industry best practices with cutting-edge technology to deliver a solution that is both powerful and intuitive. We're committed to helping researchers and clinicians focus on what matters most—advancing patient care.
Trusted by leading research institutions
24/7 dedicated support team
Continuous platform improvements
Transparent, predictable pricing
About Arch Clinical Analytics
Software written by people who've sat on trial teams.
ACA was founded by clinical data managers and surgical researchers frustrated with tools built for generic industries and retrofitted for medicine. We build for oncology and precision surgery first — the edge cases are the whole point.
"We moved case documentation for our surgical oncology trial from paper binders to ACA in under six weeks. Query resolution time dropped by nearly half in the first quarter."
See ACA on your own trial data.
We'll walk through a live instance configured around a workflow you recognize — no generic slideware.
Contact
Let's talk about your trial.
Tell us about your study and we'll set up a walkthrough tailored to your workflow.
Phone / WhatsApp
Support hours
Mon–Fri, 6:00 AM – 6:00 PM PT