Last week we unveiled the new OpenClinica, the product of two years of effort based on the needs, insights, and collaboration of our community. Posts here and here highlight OpenClinica’s new features and user experience. I’d encourage you to try it for yourself to get a first-hand perspective. You’ll see a solution that:
- 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?
- Better forms:
- 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
- Study DesignerTM:
- 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|
|Encourage innovation||Prioritizes integration capabilities of the platform|
|Maintain transparency||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|
|Enable researchers||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!