OpenClinica Reviews

The software is very user friendly and yet embedded with very powerful functionalities for creating a study. It also allows the extraction of datasets in various formats in a very well organized output with some being pre-coded for ease of use.

Still a few limitations with customizing the user interface, but a great improvement from the previous versions.

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.

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

nothing

the lack of ease of use

Highly cost effective for small firms; company's focus on developing a robust, competitive SaaS solution for clinical data management; Company's dedication to enhancements based on company's evolving needs.

ePRO module has some limitations related to its effective use for patient diaries.

Thank you for the great review John! We also appreciate your candor on Participate and we continue to enhance the functionality on that module. We would love to hear your thoughts on making Participate more effective for diaries. Axogen has been a fantastic client and we love working with you folks. All the best! Your friends at OpenClinica

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...

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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.

Automated variable level audit log/change tracking

Difficult to import lists/data

Our business requires continuous frequent changes to study design. The OpenClinica design tools make it easy for non-technical resources to make, test and then deploy changes while maintaining compatibility with previous iterations. In the event that the required form logic is really complex, OpenClinica professional resources are there to assist. The webservices allow us to enroll participants and schedule events in OpenClinica programmatically which is a significant time saver. This also made integration with existing systems and business processes much smoother.

Not applicable: OpenClinica professional services have been responsive to our needs. Our development requests over the past 18 months have been added to the roadmap and delivered on, although sometime later than expected. I consider the timeline slips the nature of development, and most importantly, the quality of code has been really solid.

Thank you for your review Nick. It's great to hear that our RESTful API has been a significant efficiency driver. The myriad software enhancements can only be facilitated through the agile methodology. Our dev team does a remarkable job aggregating, orchestrating, and delivering advancements.

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...

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

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.

OC there is an excellent application for clinical trial projects. - It is easy to build a CRF, and one does not need a technical background to develop a CRF. - It supports multi-site studies. - It supports multi-event studies - It supports multi CRFs per event studies - Support multi-section (tabs) and multi group CRF - Supports repeating events - Support grid layout questions which is helpful (e.g. if you wont record participant's medication history) - User-friendly interface - compatible with Firefox, internet explore and Chrome - Good user support - Easy to install

- OC 3 interface is not responsive ( OC4 is responsive) - No offline data entry capability - Programmer skills are needed to implement complex validations during CRF design

Great interface for sites to enter data for their subjects, repeating rows for AEs and con meds, validated system, automatic data exports, robust querying system, dynamic display of questions on one form based on answers from another form, great visual cues for data entry staff (colors, icons are meaningful), calendar control is powerful and easy to write data cleaning checks for, version control of...

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Would like to have patient compensation built-in to patient PRO module, more reports needed but are coming based on user feedback.

I have been using OpenClinica for years, and really love the new features in OpenClinica4. The web-based interface is user-friendly, and the new features of real-time queries, and auto-saving features really improve the user experience for data entry persons. The new study/form building tools, and click-button publishing studies to test/production environments make the database design much easier.

We have users report compatibility issues with different browsers. It would be great if this can be fixed, given the users are from different locations, and with different preference for browsers.

Thank you for your review Jia. We work hard to make the complex, easy. It's great to see the word easier. Browser capability is absolutely key ... I'd like to get more details from you to make sure this is addressed.

OC4 is extremely user friendly for both administrators and users. The study build is straight forward, allowing for powerful eCRFs to be designed, developed and validated with ease. Excellent customer support.

Some more search functionality when trying to find users and sites. Ability to archive studies.

Thank you for your review David. It's wonderful to hear how you have embraced OC4 and recognize the work that the team has done in optimizing the experience for our users. Your improvement suggestions are much appreciated as well.

I have had a great experience using OpenClinica EDC during the last 3 years with several studies (Observational studies, Registries and Clinical Trials). It´s a web based solution to build and manage multi-sites clinical studies. It´s a powerful platform, great user support, Data Entry and DM capabilities makes everything simple. The study build and CRF designer allows re-use across studies. Updates...

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Programmer skills are needed to implement complex validations during CRF design. Complex reports should be customized in Excel after data extract.

I continue to be impressed by how many ways we can personalize OpenClinica to our clinic setting. We were able to select the different categories we want completed for each patient, as well as unique drop-down options for everyone.

The version of OpenClinica we use does not look very modern. It doesn't affect the functionality of the software, but could be nicer to look at.

Thank you for the candid and encouraging review. Let us help you transition to the latest release, OC4. You'll find the ultra-modern (and ultra-powerful) UX you deserve! https://openclinica.com/contact-openclinica/

This product has many positive features, especially mobile crf management. It has a very good audit trail. It is easy to use. The customer support is very efficient.

The software does not natively manage GDPR privacy, and it would be useful to have more flexibility and autonomous management of randomization lists

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.

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

Hi Liz. Thank you for your great feedback. You will be delighted to know we have coding on our roadmap this Fall! That, as well as some exciting dev on eConsent, anonymous/offline forms and a whole slew of other stuff. I can't wait to say, "yes, we have medical coding." Thanks again!

Our department has recently has recently begun the process for eConsent development and deployment through the OpenClinica platform. The functionality and engaging features of the forms and other various tools within the program will make our processes run much smoother and increase our efficiency and overall ability to recruit qualified participants for our clinical trials. The OpenClinica team have been tremendous in providing support with prompt and professional communication all along the way, from the initial product demonstration through our current design and implementation stages.

So far, we are in the design and implementation stage, and no complaints.

Ease of use once you have been trained on the software

I wish it would be integrated to a Finance system as well as a Clinical Trial Management System.

Thank you for your review Maya! We appreciate your feedback. With our set of RESTful APIs, folks have been quite successful in integrating with CTM systems which are primarily for project, site management, site and patient payments, etc. where EDC (CDMS) is really the source for the clinical trial data. Thank you again!

OpenClinica has listened to their customers and it shows with this new product. Being a user for 10 years, I see the features I have personally requested in OC3 appear in OC4. The people behind the product have passion for their product.

I have trouble with using it on different internet browsers. Seems to be optimize, in my experience, for Firefox.

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