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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 Software Specifications

Appointment Management/Scheduling

e-Prescriptions

Lab Integrations

Patient Portal

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What Is OpenClinica?

Overview

OpenClinica is a leading clinical trial management software that top life science organizations use worldwide. As a cloud-based platform, it offers solutions across electronic data capture, electronic patient reported outcomes, eSource integration, randomization, and reporting. OpenClinica helps organizations design efficient eCRFs, collect high-quality clinical data, and streamline operations. Some key pain points it addresses include reducing data entry workload and automating routine tasks to speed up trials.

What Is OpenClinica Best For?

OpenClinica EHR is a leading clinical data management software top life science organizations use worldwide. As a cloud-based platform, it offers solutions across electronic data capture, electronic patient reported outcomes (ePRO), eSource integration, randomization, and reporting. OpenClinica helps organizations design efficient eCRFs, collect high-quality clinical data, and streamline operations. Some key pain points it addresses include reducing data entry workload and automating routine tasks to speed up trials.

OpenClinica Pricing

OpenClinica software cost is based on a customer’s needs and requirements. Get in touch with us to discuss OpenClinica pricing plans.

OpenClinica Integrations

The software integrates seamlessly with EHRs. However, the vendor has not disclosed any information regarding its specific third-party integration.

How Does OpenClinica Work?

Here’s how to get started with the software after signing in to the web-based portal:

  • Navigate to the dashboard to view current studies and create a new one
  • Define the study protocol and set up associated metadata
  • Design customized case report forms (eCRFs) using the drag-and-drop builder
  • Enable features on the eCRFs like validation rules, skip logic, calculations
  • Assign user roles and permissions for data entry and management
  • Initiate data capture by logging patient enrollments via the eCRFs
  • View data in real-time as it is entered by monitoring dashboard analytics
  • Generate reports at scheduled intervals or on-demand for ongoing oversight
The OpenClinica demo takes you through all of these steps in more detail.

Who Is OpenClinica For?

OpenClinica caters to all organizations conducting clinical research - from small biotech firms to large global pharmaceutical companies. Popular in the government, academic and CRO sectors, it can support trials of any size or therapeutic area. Key users include study coordinators, data managers, clinical monitors and other research professionals.

Is OpenClinica Right For You?

Is clinical research your top priority, but finding the right technology partner is weighing you down? OpenClinica could be the ideal solution to accelerate your trials. As a software-as-a-service platform, it offers the security and scalability required to support countless global projects seamlessly.

With bank-level data encryption, multi-factor authentication, and centralized access management, your sensitive patient information and intellectual property are entirely secure. Meanwhile, the cloud-based architecture ensures unlimited elasticity to adapt to your evolving needs, as it can scale from a single study to thousands, with endless concurrent users and petabytes of data at the touch of a button.

Still not sure if it's the right choice for you? Contact us at (661) 384-7070 and let our experienced team assist you in making an informed decision.

OpenClinica Software Features

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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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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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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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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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 Software

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 OpenClinica reviews

OpenClinica Software Reviews

Overall Rating

5

3 Reviews

Rating Distribution

5

star

(3)

4

star

3

star

2

star

1

star

February 2024

OpenClinica for Investigator led Clinical Trials in the UK

Vanessa

Research

Ease of use

10

Value for money

10

Customer Support

10

Functionality

10

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

February 2024

OC4 for Oncology Clinical Trials

Adam

Research

Ease of use

10

Value for money

9

Customer Support

10

Functionality

10

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.

February 2024

OpenClinica 4

Francesco

Hospital & Health Care

Ease of use

10

Value for money

9

Customer Support

10

Functionality

10

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.

Frequently Asked Questions

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