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.

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

We have been learning a lot about this software over the last couple of years and I feel we have not yet taken advantage of its full potential. The software is very intuitive and easy to navigate even if you don't necessarily have a development background. OpenClinica is always looking to improve the product and has various channels to receive feedback from users to have input in implementing or improving features within the system. So far it has been a very positive experience!

The way the user groups cannot be customisable, although already OpenClinica is working on it for the future.

I loved building the study. The options for designing forms are diverse, though some of them require learning additional skillsets to be able to implement, which they don't explain to you in the training. The design tool is lacking but once you get the hang of designing with the spreadsheets there are a lot of possibilities. Many queries cannot be sustained easily by their build in data validation system and you will need to use an external querying system to appropriately manage all the data. This would have been good to know from the beginning. They charge you for training hours but require you to use them within a certain timeframe or they expire. It's a use it or lose it thing. I don't remember that being a thing until the last year and I really don't like it at all. If I pay for the training hours that I'm forced to by in certain hour blocks of time then I should get to use them whenever I need them, not in a window of time that OC thinks is reasonable. They are paid for. The customer service people are always friendly and helpful. Some training sessions go really well, especially when you are with someone hire up on the support team, but there have been many sessions where the trainer is referring to a manual to instruct me on my question and I lose a lot of my "training hours" waiting for them to figure it out and then pass on the information. I'd prefer to just have the manual and figure it out myself.

I love the diversity in the form design. There are a lot of great features and possibilities that can make a very sophisticated form/study.

The built in edit checks/constraints are very limited in what they can do. The stuff they have is great, but the ability to do cross-form logic checks gets very messy, very fast and for some of the most simple data. You have to use a separate system to access the database for reports and full audit details called Insight and you have to pay extra to use that with your study. It's the only way to find and send reports to sites/safety teams that do not have access to Insight. The automated survey invitation tool is a mess. The system easily breaks and invitations do not get sent out as expected and the means to test this for accuracy is very difficult so you feel like you are setting up a tool blindly that is most expected to fail. The sites get very frustrated and do not trust the software to help them keep their visits on track and completed as expected. We have also run into problems where participants can access surveys too early. There has been a lot of clean up work we've had to do and a lot of hours spent trying to find all the errors since the querying system is limited in it's design to pretty basic edit checks. Cross form date checks are not at all easy and very much needed to quickly catch the system errors that happen. The randomization tool is pretty sophisticated but it also costs extra and whenever you need to do updates to the tool it's a much more difficult process then simply publishing it to test. This also adds layers of difficulty to the testing.

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.

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.

Sometimes there are minor delays on some customer support requests.

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.

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.