OpenClinica

OpenClinica for Investigator led Clinical Trials in the UK

장점:

Easy to create and update forms for data collection

단점:

Automatic scheduling is a bit limited, however this is planned to be updated soon

Moving in the right direction

주석: 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.

장점:

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.

단점:

Sometimes there are minor delays on some customer support requests.

An honest review

주석: 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.

장점:

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.

단점:

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.

Why I cannot live without OpenClinica

주석: I have worked with OpenClinica for more than 15 years and loved how it has developed

장점:

The ease of set up a new study and the management functions

단점:

I cannot think of anything, have worked with clinical studies my entire professional life and used any tool on the market and OpenClinica has resolved all the issues.

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

장점:

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.

단점:

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

I use OC 3 for over five years and found it a good electronic data capture system

주석: OC is a great application for clinical trial research projects. It is easy to use and easy to build CRFs. The user support team is very helpful and there is a big community of people who could be helpful. The new version of the application OC4 seems to be very promising and the team has done a great job with interdicting new functionalists.

장점:

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

단점:

- 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

OpenClinica 4

주석: Overall the experience with OpenClinica has been very positive so far. Apart from being an all encompassing system, it has a good support infrastructure and works pretty well even with the time zone differences (i.e., US/UK) and usually resolutions are provided in good time.
User feedback is always well received and feature changes are genuinely considered to be included in the roadmaps. We have dealt with some pretty complex projects over the last couple of years and have had a positive experience.

장점:

OpenClinica is a pretty comprehensive platform that can tailor to most if not all needs of data capture. The interface is easy to use and navigate and the drag and drop design features allow even the less technical to be able to create data capture forms with relative ease. There is a lot of material to help users understand the system and the support is good.

단점:

The customisation of user roles and permission is somewhat restricted meaning there is less flexibility when dealing with multiple different access levels. Some of the additional modules and if professional services have to be engaged to deal with user errors and compliance issues can come up a little on the expensive side especially in a an academic setting.

OpenClinica review

장점:

smart data collector tool through survey on patients in hospital care operations help to earn time easy to use outcome report in form of tests and graphic very faster than other measures

단점:

request for customer support is some time slowthe money value of the tool is still expensive for small hospitals

Personalization options are impressive

주석: OpenClinica makes it easy to us to keep track of a huge number of patients in the same place and query it for studies.

장점:

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.

단점:

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.

OC4 for Oncology Clinical Trials

장점:

The support provided by the Openclinica team cannot be beat. If I may list two things, the OC system is incredibly user friendly.

단점:

We needed a centralised system to collect quesitonnaire responses from participants, record that data, enter clinical results, and upload copies of paper work related to each participant visit. This system provides all of the above.

Enhancing Clinical Trials with OpenClinica: A Comprehensive Review

주석: I had the chance to collaborate with OpenClinica while I was interning at the university's pharmaceutical product development and research division. The program was essential in organizing the data from research projects and clinical trials. I saw first-hand how OpenClinica's flexible form builder enabled us to precisely develop and collect study-specific data items. The software's user-friendly interface streamlined and expedited the data entering process, decreasing errors and cutting down on data entry time. Our research on the efficacy and safety of medications was supported by OpenClinica's reporting and analytics capabilities, which gave us insights into patient demographics, treatment outcomes, and adverse events. Overall, OpenClinica was a great help in organizing and processing the data we needed for our research activities.

장점:

For clinical research investigations, OpenClinica has a number of benefits. The program, in the first place, offers a versatile and scalable data management platform that enables researchers to create and collect study-specific data items. The data entry procedure is streamlined, lowering errors and increasing efficiency thanks to its user-friendly interface and intuitive form builder. Researchers can get insightful knowledge from gathered data using OpenClinica's powerful reporting and analytics features, promoting the use of evidence in decision-making. In order to guarantee data integrity and safety, the program also enables regulatory compliance, including data security and audit trails. Overall, OpenClinica equips scientists with a full suite of tools for trustworthy and effective data management in clinical trials and studies.

단점:

Even though OpenClinica has many advantages, there are a few things to keep in mind. First off, the initial setup and configuration process can be challenging and complicated, necessitating qualified technical knowledge. For non-technical users, the software's advanced functionality could have a longer learning curve, demanding thorough training and continuous assistance. Users have occasionally reported experiencing performance issues with the system, especially when working with huge datasets or intricate study designs. Additionally, for smaller research institutions with tighter budgets, the cost structure of the program can be a barrier. Despite these factors, OpenClinica is a smart choice for clinical research studies due to its flexibility, extensive data management capabilities, and compliance features.

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

장점:

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.

단점:

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.

Good Research Study Database

주석: 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.

장점:

Automated variable level audit log/change tracking

단점:

Difficult to import lists/data

Flexible and agile design with robust webservices-OpenClinica delivers

주석: We took offline and paper-based processes and moved them onto the platform which has obvious efficiencies and significant improvements in audit.

장점:

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.

단점:

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.

Great product, stable for many years, always incorporating new features, great support, open source

주석: Solid platform, great user support, query system, design is currently spreadsheet based which appeals to the minds of programmers, lots of options for data export, have used it in multi-country clinical and observational trials.

장점:

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 forms, strong data integrity (can't change pre-programmed answer sets for questions without adequate control), great user support including option to contract for development at reasonable prices, built-in support for double data entry of paper forms, stable over the 7 years I've used it for clinical and observational trials, incredible user community which makes 3rd party tools available, yearly international conferences to keep users up to date, patient PRO module is very feature laden, patient PRO module creates solid link between site CRF data and patient PRO data, I have used it for 7 years and have never lost a data point.

단점:

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

User-friendly OpenClinica version 4

장점:

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.

단점:

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.

OC Enterprise offers a robust GxP compliant core EDC solution at a cost effective price point.

주석: We've enjoyed a very strong relationship with OC. They are very supportive of our changing needs, and this solution provided robust core EDC system as a very cost effective option for our growing data management programs. They trainers and programming consultants have been exceptional at helping us learn and navigate the system. The customer service has been exceptional.

장점:

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.

단점:

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

OpenClinica 4 makes setting up new studies a breeze

주석: I have been using OpenClinica for nine years, the majority of which I have used OC3, which performed well (and still does) but was lacking features other alternative products offered. However, since the release of OC4 that has all changed. OC4 is a exceptional product and a significant improvement from OC3. The ease of use has saved countless working hours but also produces high quality eCRFs - a product the OpenClinica team should be immensely proud of.

장점:

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.

단점:

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

OpenClinica makes it simple. Flexible, reliable and easy to use

주석: Flexible, reliable and easy to use

장점:

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 and amendments are a simple process. Audit trail is excellent and easy to track and data extractions are available in several formats whenever is needed for the statistician. Data management capabilities improves data quality and productive monitoring. Most CRAs were pleased with the system. OpenClinica offers Cloud Services. No need IT skills for installation and setup. Super User Training is very helpful for data managers when building CRFs. If regulatory submission is required, the Regulatory Support Package service is highly recommended.

단점:

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

Very easy to use, user friendly and logic system

주석: I really like the system - you do not have to know much about programming to use it and the OC support is just amazing

장점:

OpenClinica is a system which is very easy to use - for the basic use you can simply start with the designer and create EDC. The system is not overloaded with information and therefore user-friendly. I use this program every day in my projects and my clients also praise this system very much - after a short training they are able to start using it. I really appreciate that the system allows for many possibilities to design CRFs. A super useful thing are also the ePROs and ruls option.

단점:

I hope new guideline version will be more detailed - the one which is available is very general

OpenClinica Software Setup

주석: OpenClinica is a great software program. If you have someone who can dedicate the time to program it, then you can get it exactly how you want it. We used the excel sheets to program ours and not the other way. I'm sure it is easier to do it the other way, but it didn't have the additional feature like we wanted without using the excel sheets. Overall it is an excellent product and one I would recommend.

장점:

The training was really nice and their support line is fast. They have a 24 hour turn around and sometimes they are much faster than that. It was easy to program once I learned how to do it. We did like the example files, like the Kitchen Sink file. Most everything we needed could be found there.

단점:

It was a bit of a learning curve to get how to use this software but I must admit, once we learned how to use it, it wasn't bad. There are some sorting features with long drug lists that are tough to use at times. Drop down features are a bit rough but once we figured it out, it wasn't too bad.We would have liked training videos for the excel sheets if you didn't remember your superuser training functions.

Easy to use system for the end user

장점:

There is openness to feedback on what can be improved within the system and there is typically good communication with the person helping with the form designs. Sites find the system very easy to use.

단점:

One item that I would like to see is item level/partial SDV within the form being reviewed, as well as form status that shows what forms have open queries requiring assessment.

A useful tool in a multicentre clinical trial

장점:

The ability to structure events and related forms which can be assigned to research staff or completed by participants electronically. The software is easy to use for data collection which is hugely important which many staff spread over many centres need to use it effectively.

단점:

I would prefer data extraction to be more customisable/targeted.

OpenClinica EDC

장점:

OpenClinica has easy-to-navigate features for users. It is easy to learn.

단점:

OpenClinica does not replicate blank databases at this time.

Excellent Product

장점:

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.

단점:

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