OpenClinica

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

Vorteile:

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.

Nachteile:

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

Moving in the right direction

Kommentare: 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.

Vorteile:

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.

Nachteile:

Sometimes there are minor delays on some customer support requests.

Leading in Industry

Kommentare: OpenClinica is a responsive and supportive company, run by people who are smart, adaptable, and interested in creating new and compliant solutions at the leading edge of the industry. Over the years I have watched them improve their processes and product constantly.

Vorteile:

For ease of use, efficiency, and UI, OpenClinica is my first pick. The regulatory support package is robust and validation maintenance is simple and straightforward. Development processes are well controlled and the company is at a mature place in testing and compliance. Aside from really nice software, the people are really lovely and provide excellent support.

Nachteile:

There are some features still in development that I look forward to.

Difficult to use for doctors (maybe easy for programmers)

Kommentare: 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.

Vorteile:

nothing

Nachteile:

the lack of ease of use

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

Vorteile:

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.

Nachteile:

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.