See the video now, join the webinar on March 26 or 28.
You know it better than anyone: clear, on-demand reporting is more than a “nice to have” in our field. It’s essential to conducting research that’s efficient and safe. That’s why we’re launching OpenClinica Insight. Insight makes it easy to ask questions of ALL of your clinical and operational data and visualize answers via interactive reports and dashboards.
Learn more at either of these upcoming webinars:
Monday, March 26, 8pm GMT, or
Wednesday, March 28, 8am GMT
The idea is simple, but the results are powerful: ask your questions, choose your visualizations, then return often for updated, interactive results that link you to all of the underlying data.
We’re excited to start 2018 with our most significant new release in 10 years. We want to give you all the details in one info-packed hour.
On Monday, January 22nd, from 11am to 12pm EST (UCT-5), learn about the smarter way to build and publish studies, create mobile-friendly forms, and manage your data. We’ll also show you the rock solid security, compliance, performance, and reliability that comes with our cloud hosting.
Provides easy, self-service onboarding for all user types
Is built around “Smart paper” eCRFs – richly interactive, mobile-friendly forms that autosave your data yet give you as much control over layout as if you were designing them in Word
Gives you a collaborative, drag-and-drop study build environment with validated design->test->production pathway for your studies and amendments
We couldn’t deliver these enhancements without under the hood changes that are just as significant as what you see in the user interface. So what are some of those changes?
What’s under the Hood?
The new OpenClinica is a multi-tenant cloud platform that embraces open source, automates provisioning, and provides validated traceability, massive scalability, and high-grade security.
By breaking from the monolithic application model and turning to a microservices model built for the cloud, we’re able to deploy more user-friendly, productivity-enhancing features quickly and reliably. A traditional monolithic software application encapsulates all its functionality in a single code base, continues to grow in complexity as it adds new features, and requires deep expertise in the code base to fix or improve even minor things. With the microservices model, each service performs a small set of business functions, and is built around a web services API from the start, making it far easier to configure, integrate, and orchestrate functionality within the platform and with third-party systems.
For those of you familiar with the OpenClinica 3 architecture, a few of the key changes are:
Separation of study build and study runtime functions into discrete systems
The ability for the study build system to publish a study definition (or updates thereof) to test and production environments to simplify validation / training / UAT / re-use
A new model for building forms, based around the powerful and widely used XLSForm standard.
Use of separate database schemas for each study, increasing scalability, portability, performance, and better support of the full study lifecycle
A single-sign-on mechanism across the OpenClinica systems and services, with ability to plug in to third party authentication mechanisms more easily
Together, these changes make OpenClinica easier, more powerful, smarter, and more open.
Our vision is to harness open technology to make research better. The new OpenClinica is fast to adopt, simple to learn, and a joy to use, whether you’re a data manager, CRA, investigator, or study subject. It doesn’t just capture data: it empowers the entire trial team to work fast, with high quality, and to monitor and respond in real time to challenges that arise. It enables the rapid exchange of clinical, laboratory, imaging, and patient-reported data, with the intelligence to take action on it.
Compliance with all pertinent FDA and EMA regulations, including GCP, 21 CFR Part 11, Annex 11, and HIPAA, continues unchanged, as does our SSAE-16 SOCII/ISO certification.
It doesn’t end there, either. The new architecture provides greater scalability, redundancy, and zero downtime; is modular, built for integration and extension; and is able to evolve faster and more flexibly.
For today’s complex clinical research needs, the leverage we get from modern cloud, DevOps, test/build automation, best-of-breed frameworks designed for microservices is enormous. But there are some trade-offs, including the need to manage 10-50 services at a time instead of 3 (database, application server, application) in the old model. Thus, the new OpenClinica is built to be consumed as a native cloud-based solution. This means that it’s not feasible to provide an easily downloadable ‘Community Edition’. Even with a massive amount of effort, packaging all of those services up into a straightforward download/install process that works reliably in a generic set of environments would be hard. Or, as one of our engineers put it, “a nightmare-inducing morass of things-that-could-go-wrong when it’s not used in the context it was specifically designed for.” By highly automating our cloud environment, we are focusing our engineering resources on getting the most secure, fail-safe, fastest, and highest quality user experience possible shipped and available for your research.
For all the added muscle, the new platform retains the heart of OpenClinica. Most of the database schema is the same. Much of the OC3 source code has been adapted to work within the new architecture. As with OpenClinica 3, most (but not all) of it is open source and available on GitHub. OpenClinica was conceived as a commercial open source project–one that has thrived in large part due to the enthusiasm of developers, domain experts, and practitioners who know that collaborative innovation benefits everyone. This ethos continues to guides the OpenClinica LLC team and inform our work.
What’s new in OC4?
Real-time edit checks and skip logic
Easier and more powerful logic for validation, skips, calculations, and inserts
Real-time, field-by-field autosave
Mobile-friendly design and UX suitable for any device
Layout options for every use case
Build studies using a drag-and-drop interface
1-click publish to test/production environment
Preview forms and edit checks
Define study events, append associated forms, and more
Collaborate in real-time with other users while building and testing studies
Easily re-use forms and events
Form and protocol versioning
Data extracts that reflect clearer form versioning
Self-service training embedded into the user interface
Built for performance and scalability
Updates delivered safely, seamlessly, and automatically
A modernized technology infrastructure enabling future enhancements, including:
Better SDV, reporting, coding, configurable permissions, and metrics
Self-service startup to select your plan and immediately provision your instance
Libraries of reusable items, forms, users, and sites
More efficient handling of “reason for change” and cross form-edit checks
More capable and consistent API
How will this affect my existing OC3 studies?
For existing users, we recommend starting new studies on the new OpenClinica cloud while you keep your OC3 installation for studies already underway. Studies you are conducting on OpenClinica 3 will continue to receive the best-in-class support you’ve always known, all the way through to their completion. While major new features and improvements will focus on the new platform only, we have made more than 50 improvements to OC3 in 2017 alone, and will continue to produce maintenance releases as long as existing studies remain in production.We’re not yet able migrate existing study data from OC3 to OC4, given differences in the form definition model. We’re working on it!
Can I use both OC3 and OC4 at the same time?
Yes! We recommend starting new studies on OC4, with one exception: studies requiring double data entry. This feature is not currently supported on OC4.
How will I get trained and request support?
Integrated training, help, documentation, tutorials, and videos are embedded right into the OC4 application. In addition, our stand-alone training modules and dedicated client services team will be available as always to ensure your success.
What do I have to learn?
The new OpenClinica is far more intuitive, and has tutorials and guides embedded in the application. The biggest change between OC3 and OC4 is the form design model. We offer plenty of resources, training, and examples to help you understand the difference. We’ll be releasing a drag-and-drop form designer and enhanced form library capabilities very soon.
What is the cost?
Plans and pricing are the same for OC4 as for OC3, and based on the number of studies you are actively running. To calculate the number of studies, we’ll add together the studies you have on OC4 and OC3.
You will keep your current pricing through the end of your contract. At the end of that term, you may renew at then-current pricing, whether you upgrade to OC4 or not.
Although we stopped offering plans with ‘unlimited’ studies some time ago, some long-standing customers remain on unlimited plans. At the end of their contract, we will assist these customers in selecting a plan that includes ample studies for current and projected projects at a per-study price that remains cost-effective.
We’ve introduced some new plan options whose flexibility and scope we believe will better serve you. Discounts are available for academic institutions and hospitals.
Is OpenClinica still open source?
As with OpenClinica 3, most (but not all) of the new OC is open source and available on GitHub. OpenClinica was conceived as a commercial open source project–one that has thrived in large part due to the enthusiasm of developers, domain experts, and practitioners who know that collaborative innovation benefits everyone.
Key motivators for open sourcing OpenClinica have been, and continue to be, (1) encouraging innovation, (2) maintaining transparency, and (3) enabling researchers. These principles continue to guides us and inform our work. The new model aims to improve the way these goals are met by:
prioritizing integration capabilities of the platform
keeping key parts open
incorporating and contributing significantly to widely used, third party OSS projects, and
providing a cost-effective and quickly deployable solution, thereby avoiding the potential technical hurdles, security pitfalls, and time costs of maintaining self-provisioned instance.
Key motivators for open sourcing OpenClinica
How the new OpenClinica improves the way these goals are met
Prioritizes integration capabilities of the platform
Keeps key parts open and accessible. Contributes significantly to widely used, third party OSS projects. Continues the RSP which facilitates structured, complete audits for users requiring it
Provides an affordable and quickly deployable solution, thereby avoiding the potential technical hurdles, security pitfalls, and time costs of maintaining self-provisioned instance.
In the near future we will offer a low-cost plan, “OC Ready”, that gives you access to the key features of the new OpenClinica, including the new protocol designer, form engine, and more.
How can I contribute to this innovation?
Open source, open APIs, and readily available tutorials empower developers and technical users to push the envelope of what’s possible. We plan on releasing an OpenClinica “toolkit” for building integrations and health research apps that guarantee high-integrity, trustworthy data and rigorous standards of quality. When it’s available, developers of all experience levels will be able to:
Obtain an API key
Download the toolkit/SDK
Consult API docs & tutorials
See an example module
Build a UI or integration module using the toolkit
Share their module
Improve an existing module
The OC4 Toolkit is still under development, so stay tuned!
In the previous post in this series we covered how the new OpenClinica makes study build, change control, and collaboration so much easier. This improved user experience doesn’t end at first patient in. Take a journey through the heart of the new OpenClinica: its incredible form engine.
As you bring research sites and study team personnel into the fold, they’ll be greeted with a friendly invitation and smooth on-boarding.
Integrated walkthroughs help get your study personnel up to speed quickly.
After a new user responds to their email invitation, OpenClinica will direct the user to the appropriate part of the system and offer a brief tutorial of the application. When they’re ready to go deeper, in-depth online training and on-demand assistance are available.
Connections can sometimes disappear, but data should never get lost.
The solution? Auto-save.
Display only what's relevant.
Not every patient is the same. OpenClinica’s powerful skip logic allows you to show or hide questions, groups of questions, or entire form pages based on prior responses, making data entry more efficient and intuitive. Ask only relevant questions to avoid overwhelming your CRCs and Investigators. They’ll thank you with cleaner, more complete data faster.
Real-time edit checks alert the user to out-of-range or otherwise discrepant values.
(And how about those auto-calculations and the value piping?)
Clearer eCRFs mean cleaner data.
The form engine in the new OpenClinica can help your team minimize mistakes with clear, media-rich, mobile-friendly forms.
The world’s not perfect, and sometimes a CRC will need to leave a record in an imperfect state.
We’ll save it as-is and track the follow-up for you with auto-queries.
A picture is worth a thousand data points.
Let your participants submit images directly into the study database. A link right on the ePRO form launches their mobile device camera.
“Protocols change. I need a fast, reliable way to make needed updates without having to worry about breaking things.”
“I need a way to update forms more quickly, before and after study start.”
“My eCRF build/test/deploy process is too prone to human error.”
“I want my study team to see and take action on what needs to get done today. Then they can apply their brain power to the hard stuff.”
“I’m done with paper forms. My sites need fast, real-time data entry flows that match how they actually work.”
If so, you’re not alone. Since the advent of eClinical, we’ve settled for making paper processes work “on a computer.” Web-based technologies may have made your work faster. But so far, in moving away from paper, we’ve only traded crawling for walking.
Now it’s time to fly.
Today, we officially release the new OpenClinica, a leap forward in making research both faster and smarter. We’ve spent the last 18 months listening to users, looking at eClinical through the eyes of data managers, coordinators, and participants. We’ve tested beta versions of new technology and refused to settle for any experience that wasn’t seamless, efficient – even beautiful.
Now, you can expect to move from study idea to data extract in a logical, reliable, and speedy way. The new OpenClinica retains and adds to the power of prior generations of OpenClinica, while entirely rethinking how you get work done.
Here’s a tour of our study build system in six screen captures. Click the down arrow at the bottom of the frame to advance.
For starters, let’s take a look at how easy it is to build a study.
Associate forms with your events.
Haven’t build your forms yet? No problem. Use a form card as a placeholder. We’ll remind you to finish the form definition before you publish it.
Need to copy a form from one event to another? Remove a form?
It’s as easy as dragging and clicking. (And nothing is ever “lost”, just archived, so you can restore what you need later.)
Once you’ve added a form, preview and test it right from the design environment.
Test drive your edit checks, calculations, and skip logic, too!
Collaborate in real time.
You’ll see your colleagues’ updates as they make them.
Like what you see? In just two clicks, publish your study to a test and/or production environments.
Publishing study changes is just as easy, and OpenClinica does the hard work of ensuring the integrity of your changes.
The OpenClinica community has proven once again its passion for innovation and knowledge sharing. We received a record number of abstracts exemplifying the OC17 theme, Making the Complex Simple. Best of all, the diversity of expertise among our community yielded a set of sessions that covers a wide swath of data management challenges and solutions. To claim that OC17 “has it all” would be a cliché (and, given the breadth of our field, an obvious exaggeration). But with sessions on pseudonymization, patient registries, biobanking, medical imaging integration, and more, this year’s conference will deliver case studies and how-to’s that almost certainly bear on your research. So let me an offer another, more defensible, another cliché: OC17 has something–and more likely two or three things–for everyone.
Below you’ll find the program as of today, September 26th. (Order is subject to change.)
Monday, December 4: Track 1
Plenary session, “The Story of OC4” | Cal Collins, CEO – OpenClinica
OC4’s ultra-capable forms | Ben Baumann, COO – OpenClinica
Multi-system subject tracking, screening automation, and data exportation | Patrick Murphy – RTI
50,000 subjects, 15 countries, and 1 (multilingual) OpenClinica study | Gerben Rienk Visser – TrialDataSolutions
Is that what you thought of as you arrived at work today? It’s true. Working in clinical research, you bring positive change to the world, through the discovery, testing, and dissemination of therapies that improve people’s health.
No doubt your role (and mine) is a lot more specific and focused than that. It has to be, because clinical research is all about the details. To achieve the big changes, we need to implement, control, and communicate many other, smaller changes on a constant basis.
Sometimes, change is initiated from within. Sometimes, it’s imposed from outside. And at times, the whole context shifts. This last kind of change has dominated research for the past few years. Mobile technology, patient-centricity, healthcare upheavals, economic pressures, real-time monitoring, and genomic medicine are changing the context of how we approach research, and the nature of what we’re trying to accomplish.
Responding to this type of change requires clarity, purpose, and vision. A decade ago, a few of us started the OpenClinica project to inject a sorely needed dose of flexibility and accessibility into the clinical trials technology landscape. Now, we’re working to make it easy to adapt to the complexities of the new research ecosystem, while continuing to prioritize our original principles of flexibility and accessibility.
The biggest changes to OpenClinica in years are coming next month. As I’ll illustrate in my next post, closer to release, the new OpenClinica is designed to be both easy and powerful. It’s fast to adopt, simple to learn, and a joy to use, whether you’re a data manager, CRA, investigator, or study subject.
One thing that will never change is our commitment to the success of our customers and our community.
Like you, sites strive to capture high quality data to answer safety and efficacy questions. But that’s not an easy task, given complex protocols and the competing demands of the clinical setting. Which areas of data management would you most like to improve among your sites?