4.5 / 5 8 reviews

Who Uses This Software?

Clinical research organizations, academic institutions, pharmaceutical companies, biotech companies, medical device companies, site management organizations

Average Ratings

8 reviews
  • 4.5 / 5
  • 4 / 5
    Ease of Use
  • 4 / 5
    Customer Service
  • 4 / 5
  • 4.5 / 5
    Value for Money

Product Details

  • Free Version
  • Deployment
    Cloud, SaaS, Web
  • Training
    In Person
  • Support
    24/7 (Live Rep)
    Business Hours

Vendor Details

  • OpenClinica
  • Founded 2006

About This Software

Protocols are complex. Getting data shouldn't be. With a collaborative, drag-and-drop study designer for you and mobile-friendly forms for your sites and subjects, OpenClinica is more than just data capture. It's a better experience. The result? Higher quality data for your study, at a low cost that makes budgeting easy, too. With every deployment: secure, high-performance cloud hosting on AWS | Documented validation | FDA, EMA, GDPR and HIPAA compliance

OpenClinica Features

  • 21 CFR Part 11 Compliance
  • Document Management
  • Electronic Data Capture
  • Enrollment Management
  • HIPAA Compliant
  • Monitoring
  • Patient Database
  • Recruiting Management
  • Scheduling
  • Study Planning
  • Audit Trail
  • CRF Tracking
  • Data Entry
  • Data Verification
  • Distributed Capture
  • Document Imaging
  • Document Indexing
  • Forms Management
  • Remote Capture
  • Study Management

OpenClinica Latest Reviews

Automatically translated. Show original review

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

4 / 5
Ease of Use
4 / 5
Features & Functionality
5 / 5
Customer Support
5 / 5
Value for Money

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.

Automatically translated. Show original review

Good Research Study Database

3 / 5
Ease of Use
4 / 5
Features & Functionality
4 / 5
Customer Support
5 / 5
Value for Money

Comments: 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
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