OpenClinica4 (OC4)

OpenClinica LLC lists OpenClinica4 (OC4) on the FedRAMP Marketplace with the status Initial Implementation, at no impact level listed, on the Program path under the 20x process. Package FR2632054491, read from the marketplace feed as of September 3, 2026.

Initial Implementation20xProgram path

Section A. Register entry

What the marketplace records

FedRAMP package ID: FR2632054491
Cloud service provider: OpenClinica LLC
Certification status: Initial Implementation
Impact level: Not listed
Certification class: Not listed
Authorization path: Program
Certification type: 20x
Marketplace phase: Initial Implementation
Deployment model: Public Cloud
Register snapshot: September 3, 2026
Service model: SaaS
Independent assessor: A-LIGN
Status date: August 21, 2026
Business categories: Analytics, Data Management, Health & Wellness, Research
SAM.gov UEI: VJWGYQDM2X28
Milestones on record: 1

The marketplace carries OpenClinica4 (OC4) under package FR2632054491 with 16 recorded fields. Its current status was set on August 21, 2026. A-LIGN is named as the independent assessor. No agency authorizations are listed against it in the current feed. It is delivered as SaaS on a public cloud, filed under 4 business categories including Analytics, Data Management, Health & Wellness and 1 more. Its SAM.gov unique entity identifier is VJWGYQDM2X28.

Section B. Milestones

1 entry in the marketplace event log

Most recent first, as recorded by FedRAMP.

Event logFR2632054491

Date	Category	Recorded
August 21, 2026	Status Change	Status set to Initial Implementation

Section C. Cost context

What reaching this stage costs

Our own published ranges for a provider going through this level. Nothing here is a figure this provider has disclosed.

Cost context

No range published for this level

The marketplace lists no impact level here, so no cost range is quoted. Our impact level reference sets out what each baseline costs to reach.

Read the impact level reference / continuous monitoring cost

Path

The marketplace records 80 offerings on the Program path, 76 of them 20x. Our 20x page covers what that model is estimated to cost. FedRAMP 20x cost analysis

20x

This package is on the 20x track. Our 20x page puts an early estimate of $100,000 to $300,000 on a Low or Moderate authorization under 20x against $500,000 to $2,000,000+ on the traditional path. Those are estimates from early pilot data, not observed invoices. 20x cost analysis

Section D. Services in scope

5 services listed inside the assessment boundary

Electronic Data Capture (EDC)
Available from March 1, 2027
Core study build and data collection: drag-and-drop form design, real-time edit checks, role-based permissions, and audit trails.
eConsent
Available from March 1, 2027
Electronic informed consent workflows supporting remote, in-person, and hybrid enrollment with secure e-signatures.
eCOA
Available from March 1, 2027
Mobile patient-reported outcomes and symptom tracking with automated participant reminders.
Reporting & Analytics
Available from March 1, 2027
Real-time dashboards and exportable, submission-ready data with complete audit trails.
API Access (REST/SOAP)
Available from March 1, 2027
Programmatic access to study metadata, subject data, and event data for integration with external systems.

Section G. Nearest entries on the register

Comparable offerings

Scored on impact level, path, status, shared business categories and how close the two entries sit in the register's own timeline.

Leadership Connect
Leadership Connect, Inc.
Initial Implementation, no impact level listed, Program path, 20x.
Sustainment Digital Manufacturing Hub
Sustainment Technologies Inc.
Initial Implementation, no impact level listed, Program path, 20x.
Wisedocs for Government
Wisedocs USA Inc.
Initial Implementation, no impact level listed, Program path, 20x.
Certivo Compliance Platform
Certivo, Inc.
Initial Implementation, no impact level listed, Program path, 20x.
Partos for Government
Partos Inc.
Initial Implementation, no impact level listed, Program path, 20x.

Section H. Description

As published on the marketplace

The provider's own description of the service, reproduced from the FedRAMP feed without edits.

OpenClinica is a Software-as-a-Service (SaaS) eClinical platform that centralizes clinical trial technology for electronic data capture (EDC), eConsent, eCOA (electronic clinical outcome assessments), and reporting and analytics. OpenClinica is hosted on AWS US East/West as a Public Cloud deployment. The platform serves academic institutions, pharmaceutical, biotech and medtech sponsors, and contract research organizations (CROs) running clinical trials, including federally funded research studies.

Next step

What the same authorization would cost you

The worksheet turns an impact level, an existing security posture and an organization size into a line-by-line budget, with the 3PAO fee split out.

Open the Cost Worksheet →More Initial Implementation offerings

Provenance and independence

Source: the FedRAMP Marketplace product feed, produced by the General Services Administration. The feed's own last-change stamp is September 3, 2026; this copy was taken on September 5, 2026.

GSA's disclaimers page states that FedRAMP content about a specific commercial product or service is provided for the information and convenience of the public and “does not constitute endorsement, recommendation, or favoring by the General Services Administration”. A listing here is a record of a certification status, not a judgment about the product.

FedRAMPCost.com is an independent cost reference. We are not affiliated with FedRAMP, the GSA, any provider listed on this page, or any assessment organization, and no provider pays to appear in this register.