OpenClinica

Electronic data capture & clinical data management software

About OpenClinica

OpenClinica is an Enterprise-level electronic data capture (EDC) and management solution designed to meet the needs of clinical researchers. The single, all-in-one platform provides HIPAA compliant online deployment, offering 256-bit encryption to secure centralized data and claim ISO 9001, 27001 certification. From here, OpenClinica spans integrated modules across not only EDC and specifically clinical data management, but also the addition of randomization to studies, supply management, patient reported outcomes (ePRO & eCOA) and also reporting.

Using OpenClinica's collaborative designer, users can create studies and mobile optimized forms for every site and subject. Electronic case report forms (eCRFs) can be generated with additional features including editing checks in real time, field skipping logic and also automatic saving. Drag and drop editing allows for intuitive definition, ordering, and re-arrangement of events and forms, while audit logs ensure safe collaboration thanks to audit logs and versioning. Forms can be previewed authentically within the system, with sharing among study managers also facilitated via custom permissions. Data capture is then assisted by batch upload or API-based connectivity with existing systems, before patients and participants are able to engage and make submissions directly from any web-enabled device. Notifications send gentle reminders to participants via SMS or email to prompt engagement, while monitors can keep track of site activities from the field with access to a mobile optimized dashboard. OpenClinica also incorporates integrated reporting functions, providing bar chart and line graph visualizations for operational and clinical data which can be scheduled for sending as report updates to team leads.

Pricing starting from:

N/A

  • Free Trial
  • Free
  • Subscription

Key benefits of OpenClinica

• OpenClinica is a cloud-based clinical data capture and management solution that allows electronic case report forms (eCRFs) to be created that feature real time edit checks, skip logic and support for electronic signatures.

• Cross-form intelligence results in the creation of eCRFs that are responsive to any element of a dataset, with auto-saving on every field change.

• Patient reported outcomes, ePRO and eCOA, is supported by study participant engagement across devices, with the ability to send gentle SMS and email reminders to submit due data.

• Field-based monitors can access a mobile optimized dashboard facility to assist with guidance on tasks to perform and when, with the ability to review site activities and verify data against the source.

• Access to operational and clinical data is backed by sharable, custom reporting capabilities with visualizations such as bar charts, line graphs, enrollment graphs and more.

Devices

Business size

S M L

Markets

United States, Canada, Germany

Supported Languages

English

Pricing starting from:

N/A

  • Free Trial
  • Free
  • Subscription

Images

OpenClinica promises support for multiple devices, enabling patients to complete forms and submit required data with convenience, while monitors can also access their own online dashboard
Follow study progress closely with custom reporting capabilities and data visualizations including bar charts, line graphs etc
Patients and participants are able to provide data anytime and from any location via their own web-enabled devices, receiving encouraging notifications or reminders when pending requested data is required
Field monitors are granted access to a mobile-friendly dashboard UI that provides remote assistance across task performance, site activity reviews, plus data verification etc
Studies and eCRFs can be created, previewed and published within a collaborative, drag and drop editor
OpenClinica promises to give clinical sites a system for capturing accurate study data, with features including the automatic notification of site users with required actions, automatic study calendar management, plus electronic signature support
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OpenClinica video
OpenClinica video
OpenClinica video
OpenClinica screenshot: OpenClinica promises support for multiple devices, enabling patients to complete forms and submit required data with convenience, while monitors can also access their own online dashboard OpenClinica screenshot: Follow study progress closely with custom reporting capabilities and data visualizations including bar charts, line graphs etc OpenClinica screenshot: Patients and participants are able to provide data anytime and from any location via their own web-enabled devices, receiving encouraging notifications or reminders when pending requested data is required OpenClinica screenshot: Field monitors are granted access to a mobile-friendly dashboard UI that provides remote assistance across task performance, site activity reviews, plus data verification etc OpenClinica screenshot: Studies and eCRFs can be created, previewed and published within a collaborative, drag and drop editor OpenClinica screenshot: OpenClinica promises to give clinical sites a system for capturing accurate study data, with features including the automatic notification of site users with required actions, automatic study calendar management, plus electronic signature support

Features

Total features of OpenClinica: 22

  • API
  • Activity Dashboard
  • Charting
  • Collaboration Tools
  • Custom Fields
  • Custom Forms
  • Data Capture and Transfer
  • Data Import/Export
  • Data Visualization
  • Drag & Drop Interface
  • Electronic Signature Capture
  • Email Notifications
  • HIPAA Compliance
  • Monitoring
  • Reminders
  • Reporting & Statistics
  • SMS Integration
  • Scheduled Reporting
  • Secure Data Storage
  • User Management
  • Version Control
  • Web Forms

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Reviews

Overall rating

4,6 /5
(17)
Value for Money
4,5/5
Features
4,3/5
Ease of Use
4,2/5
Customer Support
4,6/5

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Showing 5 reviews of 17
Andrew M.
Overall rating
  • Industry: Research
  • Company size: 51-200 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 9.0 /10

Powerful form designs that compete with products ten times the price.

Reviewed on 2020/10/10

Pros

Having worked with OpenClinica and other EDC systems for several years, OpenClinica puts all the others to shame when it comes to customer service; their team bends over backward to help train, explain and fix. The software is continually improving based on user feedback.

The forms are very powerful and have almost every feature you might need: conditional display, modern responsive interface, touch friendly, lots of question types, conditional requirement, programmable notes to users.

The new version (OC4) is considerably easier to develop than OC3: no coding required, if you can write Excel functions then you can use even the moved advanced features. SDTM compatible examples of the most common OpenClinica eCRFs are readily available.

It's much cheaper than alternatives and has some features that I have only seen on the most high end products: question libraries, one-click deployment, advanced user inputs (eg drawings, VAS), localisation features, customisable ID generation etc.

Cons

The older version (OC3) requires coding experience to make the nost of it. I recommend avoiding OC3 and using OC4 instead.

Response from OpenClinica

Thank you for your review Andrew. It's great to hear from a seasoned data manager. We appreciate your acknowledgment of our team's diligent work toward greater usability and capability.

Ranjan N.
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support
  • Likelihood to recommend 9.0 /10

Moving in the right direction

Reviewed on 2020/11/03

Overall switching to OpenClinica has brought numerous benefits to our data collection methods. The...

Overall switching to OpenClinica has brought numerous benefits to our data collection methods. The learning curve for some employees has been steep, however, a few months in I can claim that it was worth the effort. I look forward to whatever new features/updates OpenClinica team has planned in the future.

Pros

OpenClinica offers a wide array of features for electronic data collection. Specifically the customizability of the forms and events when designing a survey has benefitted us immensely.
Additionally, the OpenClinica team members work hard to both understand what their users need and proactively update the software with new features.

Cons

Sometimes there are minor delays on some customer support requests.

Response from OpenClinica

Thank you for your review and candor Ranjan. We remain steadfast in our mission and passion to reduce complexity while maintaining powerful capabilities.

Paul T.
Overall rating
  • Industry: Medical Practice
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 0.0 /10

Difficult to use for doctors (maybe easy for programmers)

Reviewed on 2017/02/28

This program is a difficult program, which I tried to use for my clinical trial. Building the case...

This program is a difficult program, which I tried to use for my clinical trial. Building the case report form took ages, and a lot of frustration. Furthermore, using the CRF is not intuitive at all. I am quite disappointed.

Pros

nothing

Cons

the lack of ease of use

Catherine M.
Overall rating
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support

I used OpenClinica for ~3 years and found it a flexible and reliable system.

Reviewed on 2017/10/13

Pros

The study build is straightforward, validation/derivation procedures were a breeze to create, and data extractions easy to set up and quickly provide to my statistician. Mid-study updates/amendments were a simple process and the audit trail versioning was excellent and easy to track.
There is a learning curve for the novice data manager when building CRFs. But after the first few CRFs build from scratch, it became very easy. Also the training program I took was very good (1 week face-to face-class). I was comfortable building studies on my own within a couple of weeks of taking the class. The online user community was extremely helpful and a great resource.
As I was the only DM for some time, the site/user administration was easy to manage.
As I performed all end user training, most CRAs & CRCs were pleased with the system's ease of use for the end user. I built ~13 production studies and these functioned well as traditional EDC as well as in-house double DE databases. I found the query email function was a very helpful tool.
Customer support (using Enterprise Edition) was second to none. My questions were usually addressed within a few hours after submitting the ticket. Any unexpected issues were addressed and usually corrected that same day.

Cons

The data load process was a bit challenging. I would recommend an easier method for non-programmers to perform this task. For complex types of reports, additional tools are needed as the included extracts can be a bit cumbersome to join (depending on the report) however I was able to utilize Excel for the majority of the reporting tasks I performed.

L M.
Overall rating
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

Good Research Study Database

Reviewed on 2016/12/01

Pros:
Automated audit log tracking,
structured subject matrix for visits for visualization of...

Pros:
Automated audit log tracking,
structured subject matrix for visits for visualization of longitudinal follow-up,
capability to link subject co-enrolled in two different studies,
exportable datasets,
Some metadata / information about study protocol incorporated into the database for documentation (helpful for new employees in future),
Built in discrepancy tracking which can be linked to a specific variable

Cons:
Rigid user roles/privileges,
Import of data into system can be challenging because of structure,
Need IT background for initial setup/installation if you are setting up on own server and not using the cloud

Wishlist for future improvements:
Easier, built-in import mechanism of data into existing projects,
Make cohort groups usable within system,
Build in more scheduling features and functionality (for example, printable list of subjects expected to arrive on a particular day according to scheduled visit dates) or create reasonably priced product for this aspect which can be used as add-on,
Make user roles more flexible/al a carte,
Allow aliases for user roles as user role titles do not match structure of every organization

In my experience, many are hesitant to adopt an open source product because they may have concerns about security, reliability or functionality. After using for around 3 years and for hundreds of participants, I have found this to be a very high-quality database and certainly worth considering for small academic research organizations.

Pros

Automated variable level audit log/change tracking

Cons

Difficult to import lists/data

Showing 5 reviews of 17 Read all reviews

OpenClinica FAQs

Below are some frequently asked questions for OpenClinica.

OpenClinica offers the following pricing plans:

  • Pricing model: Free, Subscription
  • Free Trial: Available

Contact OpenClinica directly for pricing information.

OpenClinica offers the following features:

  • 21 CFR Part 11 compliance
  • CDISC import / export
  • Data entry
  • Distributed capture
  • Double data entry
  • Electronic data capture
  • Error tracking
  • HIPAA compliant
  • IT systems integration
  • Monitoring
  • Patient data
  • Patient database
  • Patient recorded outcomes
  • Randomization
  • Scheduling
  • Study management
  • Study planning
  • Supply management

OpenClinica has the following typical customers:

Large Enterprises

OpenClinica supports the following languages:

English

We do not have any information about what devices OpenClinica supports

We do not have any information about what integrations OpenClinica has

OpenClinica offers the following support options:

Phone Support, Online Support

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