OpenClinica Enterprise allows you to focus on better clinical research, not IT.


Optimized Cloud

Maximize performance and reliability of your studies, 24/7 support, zero data loss, disaster recovery. Validated and secure global infrastructure. SOC1, ISO27001 certified.

Regulatory Compliance

Complies with GCP, 21 CFR Part 11, and other regulations. Complete validation documentation and audit support.

Training and Support

Comprehensive hands-on training. Learn to build and manage your studies. Rapid support from OpenClinica experts. Library of pre-fabricated, standardized eCRFs.

Cost Effective

Make better use of limited resources. With our EDC system, you can start small and scale as needed. Cost effective for any organization.



Sites

Keep sites productive and compliant

Give sites an easy, and intuitive way to provide accurate study data. Auto-notify site users with actions required. Auto-manage study calendars. Apply electronic signatures.



Data Managers

Maintain control over your study data.

Powerful tools for centrally reviewing data, resolving queries, and flagging discrepancies. Sophisticated edit checks to ensure accurate data capture. Maintain accurate data to close studies faster. Aggregate data from disparate sources. Provide data to stakeholders in useful formats. Tools for study closeout.



Monitors

Simplify your monitors’ work.

Give your monitors a mobile friendly dashboard to assist them in the field, showing what they need to do, and when they need to do it. Review site activities, verify data against source.



Patients / Participants

Frictionless data capture from patients.

Allow patients to provide data anytime, anywhere from their own device. Provide timely notifications when data is required. More >



Sponsors

Keep up-to-date with study progress. Save time and money. Maintain regulatory compliance. Rest well knowing your data is secure.

8 easy steps for building your OpenClinica study:

Step 1 - Create Study
  • Create a profile for the study
  • Description & Status
  • Configure basic parameters
Step 2 - Create CRF
  • Design your CRF layout
  • Define your data structures
  • Add dynamic capabilities (show/hide, skip patterns, calculations and scoring)
  • Reuse forms and data elements
Step 3 - Create Events / Visits
  • Define event type (scheduled, unscheduled, repeating, etc.)
  • Select CRFs that will be associated with the event
  • Indicate if CRF is for patient, or for clinician use
  • Set requirements for SDV, double data entry, etc.
Step 4 - Create Subject Groups

Create categories for subjects–for example, to track treatment groups, cohorts, etc.

Step 5 - Create Rules

Define rules to automate routine data cleaning tasks, sending notifications, managing study calendars, and more.

Step 6 - Create Sites

Add sites to your study. Tailor the protocol by site if needed–e.g. different languages, etc

Step 7 - Assign Users

Add users to your study and manage their access privileges.

Step 8 - Add Modules

Add available modules to your study.

Integrate systems

SOAP & RESTful web servicesWeb services describes a standardized way of integrating web-based applications using XML, SOAP, RESTful open standards over the internet. SOAP and REST are used to transfer the data.

Multi-language support

Over 10 translations available

Do you have questions on OpenClinica Enterprise?

For pricing, demos, or other inquiries, please fill out form and we will respond shortly.

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