The hidden cost of your vendor stack
Fragmented systems don't just slow you down — they compound risk across every site, every visit, and every filing.
We had five systems that didn't talk to each other. Our monitors were spending more time reconciling data than actually reviewing it. Every audit was a scramble to pull documents from three different platforms.
Mid-Stage CRO, Rare Disease
Replace your fragmented stack
Stop juggling disconnected vendors. Unify every clinical operation in one compliant platform.
Every feature is built on a compliance-first foundation. Not an add-on—a prerequisite.
Centralized document management with powerful viewer
Manage the full document lifecycle — from upload through eSignature — with real-time collaboration between sites and sponsors.
- Built-in PDF viewer with annotation and markup tools
- 21 CFR Part 11 compliant eSignatures
- Version control with full document history and audit trail
- Assign documents to team members with deadlines
- Real-time sync between site and sponsor eTMF
| Visit / Activity | Screening | Treatment Period | Safety | |||
|---|---|---|---|---|---|---|
| Visit Windows / Days | Visit 1 | Visit 2 / Day 1 | Visit 3 / Day 15 ± 3d | Visit 4 / Day 29 ± 3d | Visit 5 / Day 57 ± 3d | Visit 8 / Day 141 ± 3d |
| Demographics | ||||||
| Eligibility Criteria | ||||||
| Medical History | ||||||
| Prior Beam Radiotherapy | ||||||
| Vital Signs | ||||||
| Clinical Laboratory Evaluations | ||||||
| Concomitant Medication | ||||||
Modern data capture with built-in source verification
Capture and verify clinical data without switching between tabs, systems, or paper binders.
- Side-by-side source document verification
- Visit-based form navigation with real-time status tracking
- Configurable edit checks and automated query generation
- Keyboard shortcuts and minimap for efficient review
Navigate protocols with your AI expert
Ask questions about any protocol and get instant, cited answers — all within a closed ecosystem where no patient data leaves your tenant.
- Every answer cites exact page numbers and sections
- Side-by-side PDF viewer to verify source context instantly
- Full audit trail on every query — built for GxP environments
- Supports multi-protocol search across your entire library
Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Neravex (CLT-105) in Adults with Generalized Anxiety Disorder (GAD)
Clarion Therapeutics
123 Road St East
Toronto, Ontario, Canada
A1A 1A1
Medical Advisor
Sousa, Michael
Tel: +1-416-555-5555
Section 5.2
EXCLUSION CRITERIA
Subjects meeting any of the following criteria will be excluded from participation in this study:
Your AI Protocol Expert
Welcome to the Protocol AI — your interactive guide to navigating your trial protocol. Ask questions and uncover insights quickly.
Based on Section 5.2 of the protocol, the key exclusion criteria are:
- Current diagnosis of Major Depressive Disorder (MDD)
- History of bipolar, schizophrenia, or psychotic disorders
- Active suicidal ideation (C-SSRS score ≥ 4)
- Known hypersensitivity to CLT-105
- Use of prohibited medications (MAOIs, benzodiazepines) within 14 days
Referenced from page 8, Section 5.2
See the platform in action
Book a 30-minute walkthrough tailored to your trial design.
Plan your next trial — for free
Use our interactive trial planning tool to map out your study design, estimate timelines, and identify where Clincove fits into your operations. No signup required.
Built for regulated environments
Every action in Clincove produces a complete audit trail. From electronic signatures to role-based access, compliance isn't an add-on — it's the foundation.
FDA 21 CFR Part 11
Compliant electronic signatures with full identity verification and authentication workflows.
HIPAA & GDPR
Enterprise-grade security and privacy controls protecting patient health information at every layer.
Complete Audit Trail
Every document, every data point, every action logged and traceable for inspection readiness.
Role-Based Access
Site-level permissions with granular controls for investigators, monitors, and sponsors.
AES-256 Encryption
Data encrypted at rest and in transit with TLS 1.3, ensuring end-to-end security.
Multi-Site Deployment
Deploy across sites globally with regional data residency and multi-language support.
Validated deployment in weeks, not months
Enterprise-grade setup with dedicated success teams at every step.
Protocol-first configuration
Upload your protocol document. Clincove AI generates your study binder, forms, visit schedule, and data validation rules — pre-configured for compliance.
GxP-validated environment
Your dedicated instance is provisioned with role-based access, audit trails, and electronic signatures — validated and ready for inspection from day one.
Guided site onboarding
Dedicated success team trains your sites with a single login. Average time from kickoff to first patient visit: 4 weeks.
Frequently asked questions
Everything you need to know about getting started with Clincove.
How long does deployment take?
Most sponsors are live within 2–4 weeks. Clincove's protocol-first approach means your study binder, forms, and visit schedule are auto-generated from your protocol document, dramatically reducing setup time compared to legacy platforms.
Can I migrate data from existing systems?
Yes, Clincove supports bulk data migration from legacy EDC, eISF, and eTMF systems. Our onboarding team handles the mapping, validation, and transfer so your team can focus on the science.
What compliance standards does Clincove meet?
Clincove is designed for regulated environments and meets FDA 21 CFR Part 11, HIPAA, GDPR, and ICH E6(R2) GCP guidelines. Every action produces a complete, inspection-ready audit trail.
How does pricing work?
Clincove offers per-study licensing with transparent, predictable pricing. No hidden platform fees, no per-user charges for site staff. Contact our team for a custom quote based on your trial portfolio.
Do you integrate with existing CTMS/IRT systems?
Yes, we offer REST APIs and pre-built connectors for common CTMS, IRT, and RTSM platforms. Clincove is designed to integrate into your existing ecosystem, not replace everything at once.
What training is required for site staff?
Clincove was designed for clinical teams who are not technology specialists. Most site staff are proficient within a single guided session. In-app help, contextual tooltips, and our support team ensure a smooth experience.