# OpenClinica

> A cloud-based clinical trial data collection and management platform that supports studies of any size with integrated tools for patient engagement and complian

- **Canonical URI:** https://www.vioscale.ai/software/openclinica
- **Category:** Clinical Trial Management
- **Homepage:** https://www.openclinica.com/
- **Also known as:** openclinica
- **Profile claimed by vendor:** no
- **Last updated:** 2026-10-06T22:39:34.362Z

## vioscaleAI score

**58.9 / 100**, confidence 59% (medium). Computed 2026-10-06.

Composite of weighted, independently-sourced signals (no user reviews, no vendor payment).

| Signal | Score | Weight | Contribution | Evidence present |
|---|--:|--:|--:|:--:|
| price_level | 25 | 0.105 | 2.6 | ✓ |
| reliability | 0 | 0.063 | 0 | - |
| capabilities | 91.6 | 0.043 | 4 | ✓ |
| integrations | 17.3 | 0.049 | 0.8 | ✓ |
| security_posture | 80 | 0.042 | 3.4 | ✓ |
| pricing_transparency | 100 | 0.094 | 9.4 | ✓ |

## Pricing

_As of 2026-10-06, [verify at source](https://www.openclinica.com/pricing/). Independently observed._

from $750/mo · Subscription · Free tier · 30-day trial

> From $750/month for Launch (30-day free trial). Core $3,000/month per study. Advanced $3,750/month. Enterprise custom annual pricing.

| Plan | Price | Free | Commitment |
|---|---|:--:|---|
| Launch | $750/month, no annual contract | - | monthly |
| Core | Contact sales | - | annual |
| Advanced | Contact sales | - | annual |
| Enterprise & Academic | Contact sales | - | annual |

### Launch

Single-study entry-level plan with standard templates and self-service support

**Included limits:** sites: 3, participants: 150

- EDC only
- Shared EDC with standard data limits
- Standard templates
- Study-level config and user controls
- 24/7 self-service compliance and docs
- Email notifications only
- Self-service support and documentation
- À la carte add-ons

### Core (Contact sales)

EDC with advanced reporting, analytics, API access, and dedicated customer success manager

- EDC + Reporting & Analytics
- Run multiple studies with volume discounts
- Free expert-managed study build
- Dedicated, fully isolated EDC
- Fully customizable form library
- Full admin with role-based permissions
- Vendor audit support with session monitoring
- Workflows, SMS, and full API access
- 24/5 helpdesk + dedicated CSM
- Full add-on library

### Advanced (Contact sales)

Core bundle plus one included module (eCOA, eConsent, or Randomization) for complex multi-site studies

- Core Bundle + Choice of Add-on Module
- Built for 3+ concurrent studies
- Free expert-managed study build
- Advanced analytics included, no data limits
- Complete admin with MFA and SSO
- Full user-level audit trails
- Full automation suite (workflows, SMS, APIs)
- Helpdesk, CSM, + 10 hrs Professional Services
- 1 module included (eCOA, eConsent, or Randomization)

### Enterprise & Academic (Contact sales)

All modules unlocked for large organizations and academic institutions with custom support and pricing

- Every module unlocked program-wide
- Supports 20+ studies, no data limits, multi-year flexibility
- Free expert-managed study build
- Enterprise analytics across program
- Program-level customizable templates
- Enterprise admin with MFA, SSO, and roles
- Enterprise audit trails and monitoring
- Enterprise automation and integrations
- Dedicated CSM + custom support packages

### Add-ons

- **eCOA**
- **eConsent**
- **Code**
- **Recruit**
- **Randomization**

## About

OpenClinica provides electronic data capture, reporting, and operational modules for clinical research teams. It combines study data collection with tools for patient recruitment, informed consent, randomization, and analytics, supporting researchers from small academic teams to large-scale pharmaceutical organizations.

_Independently observed._

## Platform & deployment

- **Platforms:** Web
- **Deployment:** Cloud / SaaS

## Integrations (3)

_Independently observed._

- CDISC ODM (native, bi-directional)
- S-cubed Biometrics (native, bi-directional)
- RESTful APIs (native, bi-directional)

## Capabilities

_The capabilities that matter for Clinical Trial Management. "-" = undocumented, not absent._

| Capability | Supported |
|---|:--:|
| **Capabilities** | |
| Fda 21 cfr part 11 electronic signatures | ✓ |
| Edc electronic data capture forms | ✓ |
| Etmf electronic trial master file storage | - |
| Patient recruitment CRM and screening | ✓ |
| Randomization and trial supply management irts | ✓ |
| Clinical investigator payment and stipend tracking | - |
| Decentralized clinical trial dct remote monitoring | ✓ |
| Adverse event and safety reporting | - |
| HIPAA baas business associate agreement | ✓ |
| SOC2 type ii | ✓ |
| ISO 27001 | ✓ |
| Pricing model | Per study tier |

## Security & compliance

| Certification | Status | Valid until | Auditor |
|---|---|---|---|
| SOC 2 Type II (Type II) | active | - | - |
| ISO 27001 | active | - | - |
| 21 CFR Part 11 | active | - | - |

## Facts

Every value below carries its source and our confidence. Facts are re-crawled on a freshness schedule.

### integrations

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| integrations.count | 3 | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |

### market

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| market.availability | `{"primaryMarkets":[],"availabilityScope":"global","availableCountries":[],"notAvailableCountries":[]}` | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 75% (high) |

### pricing

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| pricing.free_tier | yes | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |
| pricing.model | freemium | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |
| pricing.price_level | high | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |
| pricing.starting_price | `{"amount":750,"currency":"USD"}` | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |
| pricing.transparent | yes | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |

### security

| Attribute | Value | Source | Retrieved | Confidence |
|---|---|---|---|---|
| security.gdpr | yes | [link](https://www.openclinica.com/education/openclinica-compliance-support/) | 2026-10-06 | 75% (high) |
| security.hipaa | yes | [link](https://www.openclinica.com/education/openclinica-compliance-support/) | 2026-10-06 | 75% (high) |
| security.iso27001 | yes | [link](https://www.openclinica.com/education/openclinica-compliance-support/) | 2026-10-06 | 75% (high) |
| security.soc2 | yes | [link](https://www.openclinica.com/education/openclinica-compliance-support/) | 2026-10-06 | 75% (high) |
| security.trust_center | https://www.openclinica.com/trust-and-compliance/ | [link](https://www.openclinica.com/pricing/) | 2026-10-06 | 60% (medium) |

---
*Source: vioscaleAI (https://www.vioscale.ai/software/openclinica). Independent, evidence-based software intelligence. Cite the canonical URI.*