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Overview

Struggling to optimize clinical trials and data management? OpenClinica offers intuitive platforms to streamline operations and automate workflows. Explore how its electronic data capture solutions reduce manual labor while enhancing data quality. Now collect patient-reported outcomes from any device through mobile-optimized ePRO tools. Learn about its OpenClinica's scalable architecture now!

OpenClinica Specifications

  • Appointment Management/Scheduling
  • e-Prescriptions
  • Lab Integration
  • Patient Portal

OpenClinica Features

Electronic Data Capture (EDC)

OpenClinica allows users to create electronic case report forms (eCRFs) for remote data collection. These eCRFs can be customized with features like skip logic and validation checks. Users can design intuitive eCRFs via a simple drag-and-drop interface. Data is captured in real-time and stored securely in the cloud. Audit trails ensure regulatory compliance.

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Randomization

OpenClinica supports randomization of trial subjects during data capture through configurable randomization methods and algorithms. Randomization codes can be generated on-the-fly. Block and stratified randomization are supported. Randomization data is securely linked to corresponding eCRFs.

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Electronic Patient Reported Outcomes (ePRO)

The system offers HIPAA-compliant electronic questionnaires for remote collection of patient-reported outcomes data via web and mobile. Real-time data is captured directly from patients. Notification prompts improve compliance. ePRO sync with EDC avoids duplicate entries.

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Reporting

Comprehensive dashboards and reporting tools enable real-time monitoring of operational and clinical metrics through graphs, charts and customized reports. Configurable permissions control report access. Scheduled distribution keeps stakeholders informed. Analytics detect data trends.

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Data Management

Centralized data management capabilities include data standards management, data validation, query handling and review of audit trails for quality oversight and compliance. Role-based access controls ensure data security. Configurable workflows streamline review processes. Integrated change management yields transparency.

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Pros And Cons of OpenClinica

Pros

  • Offers a separate system for audit details called insight, which tracks all user activity and changes made in the clinical data management system

  • Offers bar charts and line graphs to OpenClinica team members

  • Secure and Compliant clinical data management

Cons

  • Cloud-hosted only, no on-premise option

  • Support may be required for complex requests, according to some user reviews

OpenClinica Reviews

Total 3 reviews

5

All reviews are from verified customers

Rating Distribution

5

Stars

100%

4

Stars

0%

3

Stars

0%

2

Stars

0%

1

Stars

0%

Share your experience

F
Francesco

Healthcare, 51-100 employees

More than a year

5.0

“OpenClinica 4”

Pros

OpenClinica is a comprehensive platform that meets most data capture needs. Its easy-to-use interface and drag-and-drop design make form creation simple even for non-technical users. There's plenty of material to help users understand the system, and the support is excellent.

Cons

The customisation of user roles and permission is somewhat restricted meaning there is less flexibility when dealing with multiple different access levels. Some of the additional modules and if professional services have to be engaged to deal with user errors and compliance issues can come up a little on the expensive side especially in a an academic setting.

Rating Distribution

Ease of use

10

Value for money

9

Customer Support

10

Functionality

10

A
Adam

Healthcare, 1-10 employees

More than a year

5.0

“OC4 for Oncology Clinical Trials”

Pros

The support from the Openclinica team is unbeatable, and the OC system is incredibly user-friendly.

Cons

We needed a centralised system to collect quesitonnaire responses from participants, record that data, enter clinical results, and upload copies of paper work related to each participant visit. This system provides all of the above.

Rating Distribution

Ease of use

10

Value for money

9

Customer Support

10

Functionality

10

V
Vanessa

Healthcare, 11-50 employees

More than a year

5.0

“OpenClinica for Investigator led Clinical Trials in the UK”

Pros

It is easy to create and update forms for data collection.

Cons

Automatic scheduling is a bit limited, however this is planned to be updated soon

Rating Distribution

Ease of use

10

Value for money

10

Customer Support

10

Functionality

10

Frequently Asked Questions

What level of support does OpenClinica offer?

OpenClinica EMR offers 24/7 expert customer support via phone, email and online ticketing. Implementation services and training are also provided.

Who are the typical users of OpenClinica?

Typical users include clinical research coordinators, data managers, physicians and drug trial monitors across various industries and company sizes.

What languages does OpenClinica support?

The user interface is offered in English.

Does OpenClinica support mobile devices?

Yes, ePRO data collection and access to dashboards/reports is fully supported through mobile web experiences on any device.

How much does OpenClinica software cost?

Pricing is tailored to your specific requirements and volume levels. Contact us for your customized quote.

Is OpenClinica free?

No, the software is not free.

How does OpenClinica provide audit details and tracking capabilities?

OpenClinica gives clinical researchers full audit details called Insights to track all user activity and changes made in the system. This separate system, accessible from within OpenClinica, captures a complete record of edits, downloads, and data exports for full traceability and compliance with regulatory standards for clinical data management.

Can I access surveys and track inventory from OpenClinica?

Yes, OpenClinica allows you to capture patient-reported outcomes and, access surveys on any device and manage drug supply inventory directly in the system through the integrated randomization and supply management features. You can randomize trials with all standard methods and better track inventory levels with a seamless experience. OpenClinica aims to empower clinical researchers with better data and streamline operations across departments with customizable solutions tailored to your needs.