Introducing OpenClinica v4

The OC16 Conference (Oct 3-4 in Boston) is two weeks away and I’m thrilled to be there to introduce the all-new OpenClinica.

The OpenClinica project started 11 years ago with two goals in mind: use the web to help clinical researchers get better, faster data, and champion an open technology model that gives users the power to extend and customize it to their needs.

These goals remain our main focus and are as important as ever. Achieving them improves quality, gets new discoveries to patients faster, improves patient satisfaction, and reduces costs. But clinical trials keep getting more complex, expensive, and harder. Better technology is a must, and it’s time for OpenClinica to evolve.

Here’s a quick preview of what we’ll be showing at OC16. It has two main components:

1. OpenClinica 4 is a self-service e-source, patient engagement, and EDC platform with low cost of entry, rapid startup, optimized workflows, and massive scalability. It is designed to save time, work great in mobile environments, and encourage better collaboration. Picture:







  • Working with your colleagues in real time on protocol design, in a visual, drag-and-drop way. When ready, its one-click to deploy to test, training, and production environments,
  • A fast, mobile-friendly, flexible forms engine with real-time edit checks, powerful expression logic, and advanced multimedia capabilities
  • Quickly, seamlessly, and securely inviting other users. Have them trained and working productively with the system in a self-service, fully automated way, and
  • Smart & customizable reports, dashboards, and queues that help you work better.

2. The OpenClinica 4 Toolkit is an open, modular environment for building health and research apps that guarantees high-integrity, trustworthy data and adherence to rigorous standards of quality. Developers in healthcare need to be able to easily build mobile & web-based health apps with powerful data collection, workflow, messaging, and visualization capabilities. A junior developer or a healthcare professional with some web programming background will be able to set up a development environment in 5-10 minutes, get a free developer key, and build a ‘hello world’ module in under 30. The toolkit, with a smart mix of modern web & mobile tools, the right amount of domain-specific intelligence, and guaranteed data integrity & security, can unlock immense productivity and innovation. The fundamental features OpenClinica is already built around– trustworthy data provenance, flexible data models, secure REST APIs, and high quality–are a great basis for such a toolkit.

Some key parts of the OpenClinica 4 technology have already been in use for over a year now in OpenClinica Participate. OpenClinica LLC’s engineers have been hard at work on the first four components of OC v4:  the protocol designer, the new form engine, a multi-tenant cloud architecture with single sign on, and self-service training. We will be putting these into use in trials early next year. Other components, like customizable dashboards, workflows, and improved reporting, and the toolkit will soon follow.

Over the past several months, 25 dedicated members of the OpenClinica community, with expertise in clinical trials, EDC, ePRO, data management, and community-based development, have worked in five advisory groups – EDC, Study Startup, eSource, API, and Community – providing strategic direction and ideas to shape the new OpenClinica.

Want to find out more? OC16’s opening panel will have a member of each advisory group sharing their view on where OpenClinica is going, and throughout the day we’ll have live demos, discussion, and training on OpenClinica 4. Come join us at OC16!




Network with OpenClinica at Mobile in Clinical Trials and DPharm

Busy Q4 2016 events program getting underway

This fall sees a busy events calendar for OpenClinica. In the run up to OC16 which starts on 3 October, OpenClinica is participating in some important events for the CRO community from September 19 – 21. Some may have registered already, but if you haven’t quite decided yet, these events are truly noteworthy.

They are essential for keeping you up-to-date and in the loop on the increasingly pivotal role of digital and cloud-based technology on clinical trials and the general advancement of life sciences.

These events are being held back-to-back in the same location, so if you’re attending one, then it’s worth getting more out of your time in Boston by making time to be at both.

The Conference Forum’s 3rd Annual Mobile in Clinical Trials

September 19, 2016 – The Fairmont Copley Plaza, Boston, MA

The program is led by Daniel Karlin, MD, Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer, Inc. The 2016 program is packed with the latest thinking, insight and updates into what’s real and proven in the application of mobile technology to advance clinical research.

Ben Baumann, OpenClinica COO is featured in panel discussion with other experts in various aspects of mobile in clinical trials, including wearables, IoT, BYOD, endpoints, validation and barriers, and research on messaging to engage patients. Moderated by Daniel Karlin, this session starts at 8.45AM: How are we Using Mobile in Clinical Trials Today? What are the Current Barriers?

6th annual DPharm: Disruptive Innovations to Advance Clinical Trials

September 20 – 21, 2016 – The Fairmont Copley Plaza, Boston, MA

The organizers are dedicated to presenting the annual event that the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development.

Originally conceived as an industry forum on thinking radically differently about the way clinical trials are performed, the conference brings together disruptive thinkers and change makers eager to discuss current solutions in clinical development, propose innovative changes, and commit to testing and sharing the results in order to transform drug development and the industry.

Ben Baumann will be in attendance at DPharm.

Meet OpenClinica at Mobile in Clinical Trials and DPharm

We invite anyone planning to attend either event to track down Ben and introduce themselves, network with him and have a one-to-one informal chat. It’s good to talk… Hope to see you there!

Look who’s talking at OC16

The OC16 conference will shortly get underway in Boston on Monday, October 3rd 2016 at the Harvard Medical School. The line-up across the two-day program is made up of noteworthy experts and practitioners in the field of EDC, who will be sharing their knowledge and experience with the OpenClinica community. Here are just a few of the great speakers who will be taking part:

Morgan Hess-Holtz

Based at the Gorgas Memorial Institute for Health Studies, Panama, Morgan Hess-Holtz will be leading an informative breakout session discussing the use of OpenClinica in a prospective, multi-center cohort study in Latin America, on Monday 3rd October at 10:00 – 11:00am.

Lindsay Stevens

Lindsay Stevens will be leading two sessions at OC16, a Community Datamart breakout on Monday 3rd October, 11:00 – 11:55am, and a look at Tablet Data Collection with ODK Collect at 4:15 – 5:10pm.

Lindsay holds a Bachelor of Science from Macquarie University and joined the Kirby Institute, University of New South Wales, Australia in 2013. He provides data systems development and support to the VHCRP, with extensive experience of programming languages and EDC platforms. Systems developed include OpenClinica studies, OpenClinica reporting systems, and offline ODK collect surveys.

Patrick Murphy

Patrick Murphy holds a BS in Chemical Engineering from Northwestern University, and is Senior Director of Data Management at RTI-HS. He has personally led the 21 CFR Part 11 validation of many clinical database systems, including Clintrial and OpenClinica, and has provided on-site data management support to observational studies and clinical trials globally.

Patrick will be discussing Lessons Learned: Naming Conventions, Rules, and Data Cleaning in Grids on Monday 3rd October from 2:00 – 2:55pm.

Jacob Rousseau

Jacob Rousseau, Senior Clinical Developer at the Netherlands Cancer Institute is an OpenClinica developer/administrator, and contributes to the maintenance of the website. Jacob will be revealing the secrets behind Streamling OpenClinica Data Uploads on Monday 3rd October, 3:15 – 4:10pm

Brittany Couture

Brittany Couture is a Research Assistant at Brigham and Women’s Hospital in the US presenting to us on Monday 3rd October, 3:15 – 4:10pm. The topic of her session is MySafeCare and the use of OpenClinica and other open source software to provide hospitalized patients and their families with a quick, electronic, and real time way to submit safety concerns to appropriate hospital staff.

Ready to register?

Click here to visitRegister-Button the OC16 Conference Page to see the full program and reserve your space now.

OC16 Program Announced!

There is not long to go now until OC16 kicks off at the Harvard Medical School New Research Building in Boston on Monday, October 3. We’re very pleased to be able to announce our full program and speakers.

At OC16 we’ll be hearing from more than 17 speakers from across the world, and you’ll have some not-to-be-missed opportunities. These include:

  • Meeting and networking with your peers in the community
  • Participating in discussions about the future of clinical data
  • Discovering innovation and finding out what’s next for OpenClinica

Day 1 highlights

The event will kick off on day one with an opening plenary from OpenClinica co-founder Cal Collins, followed by a panel discussion from our new Advisory Group. This session will be a great opportunity to hear about OpenClinica’s development and its influence on the future of clinical data.

After this, 12 sessions will run over the course of the day, split into two streams giving you a wide variety of topics to choose from. We’ll finish in the evening with a cocktail reception at The Isabella Stewart Gardner Museum, also known as Fenway Court. The evening event will showcase various technology demonstrations as you unwind with the rest of the community.

Day 2 highlights

Day two lets you get hands-on and feature a series of workshops led by fellow users, giving you a chance to develop best practice, expand your knowledge and learn from your peers. There will be morning and afternoon workshops offered.

Super User Training

If you’re in Boston for OC16 get more out of your time here! In conjunction with our annual conference, we will be offering our user training following the event, October 5th-7th. In this course you will learn how to use OpenClinica from the perspectives of all user roles, both site-level and study level. OpenClinica Super User training is great for people responsible for building studies, and training/supporting other users. To register, visit our Super User Training page.

Ready to register?

Click here to visitRegister-Button the OC16 Conference Page to see the full program and reserve your space now.


OC16: Call for Abstracts!

OC16 is coming to you this fall at the Harvard Medical School New Research Building–save the date!

Monday, Oct 3rd: Sessions & Demos
Tuesday, Oct 4th: Workshops
Wed-Fri, Oct 5th -7th: Optional OpenClinica Super User Training

The 2016 OpenClinica Global Conference is a unique opportunity to meet with and learn from OpenClinica users around the globe while discussing OpenClinica’s impact on the future of clinical data. Join us for a high-impact event in the heart of Boston’s medical research area to collaborate, integrate, and participate at all levels with the OpenClinica community.

The two-day conference will showcase new developments with OpenClinica’s architecture, preset case studies, illustrate exciting new modules, and much more.

Are there integration, strategies, or techniques you’d like to share? Connect with the community and illustrate your work at OC16!

Submission deadline is July 15, get your abstract in now! For more, visit OC16 conference page.



“An approximate answer to the right problem is worth a good deal more than an exact answer to an approximate problem.” – John Tukey

Biopharma, governments, and the healthcare industry as a whole are grappling with what really provides healthcare value, and how to evaluate and measure it. Though not a new problem, it’s one that is now front-and-center as established models for healthcare research and evaluation are proving too slow, costly, and restrictive for today’s needs.

At the same time, easy-to-use mobile computing is everywhere in our day-to-day lives, providing the pipeline to ever more comprehensive and accessible data about our world.

How are these two things related? The relative lack of mobile technology in health research illuminates the limitations of research designs and data gathering methods from the 1970s that are still relied on today.

In field after field for the past 30 years, Internet technology has shown it can radically democratize and commoditize information, through automation and scaling with low-to-zero marginal costs. There’s a fancy term for this: disintermediation. Many in the healthcare and clinical research fields are looking toward general-purpose consumer mobile technology to disintermediate themselves from the data they seek. Direct engagement with patients using a mobile-centric, real-time approach is a big part of the way forward. This disintermediation aims for greater efficiency and improved accuracy in research. In some cases, entirely new ways of looking at problems may result from the ability to passively collect continuous data streams – the Parkinson’s mPower study is a great early example.

There’s no question population health and observational research are being transformed by the ability to use mobile technology on a wide scale: A flood of low cost wireless sensors coming to market opens possibilities for ubiquitous, passive data collection. We have an unprecedented ability to engage and capture near-real time, in some cases, continuous data at a very low burden to the participant. Online communities are empowering patients by bringing together people who share a common disease burden and providing them with the chance to interact, share knowledge, and compare experiences like never before. This often includes raising the visibility of research participation opportunities. 

The needs of interventional research are changing too. An increased emphasis by payers and providers on effectiveness requires understanding how patients and therapies work in the real world. With the ubiquity of smartphones, we can collect patient-reported measures in a far more meaningful and timely way than with paper diaries or dedicated hand-held devices, allowing us to develop the evidence needed for a value-based market. Even in pivotal randomized registration trials, we can introduce changes to help better engage and retain patients, shorten timelines with adaptive designs that rely on real-time data, and do so in a way that improves these studies’ ability to demonstrate safety and efficacy.

We’re still in the early days of this patient-centric era. Most mHealth and virtual trial systems are bespoke platforms with purpose-built apps. These custom built solutions can be coded exactly to the needs of a given project. But building custom solutions sacrifices reusability and inhibits the ability to start the next project fast with out-of-the box, proven technology.

At OpenClinica, we are working to achieve both. We aim to combine the rigor and exactness of RCTs with a big data/population based approach that yields richer answers about how the real world works. The best way to do that is with a platform that creates a unified experience based on reusable, but customizable components. Our nearly 10 years of work in electronic data capture has taught us a lot about how to ensure data integrity and enable our customers to implement research protocols without writing code. At the same time, we’ve built a user experience for study participants that from the ground up is designed around simplicity, mobile-friendliness, and, ease-of-use. We’ve focused on components that solve problems in a generalizable way and just work, while also providing the means to tailor the user experience and features to meet the unique needs of each study.

Every day is an exciting challenge as we and our customers learn more about the patients we both serve.  Just a few months after the launch of OpenClinica Participate, we have started, or will soon begin, connecting patients in a daily diary study on nutrition, a behavioral health risk screening study, a hospital safety outcomes project, a long-term maternal & child health cohort, and two surgical device studies, including one involving photos captured directly from mobile devices. We’re rapidly making refinements to their user experience and adding features that help improve the speed, convenience, and quality of the research. With these new approaches comes changes at every level: research design; privacy, ethics, and consent; data validity; regulatory compliance; and analytical models. But the potential payoff is great – we now have new abilities to ask big, important research questions that have been impossible to answer in the past.


The Forecast is Cloudy

GE recently announced it is moving its 9,000 supported applications to the cloud. Nowadays, all of us are bombarded with information about “the cloud”, and it can be hard to wade through the hype and hyperbole to understand the landscape in a way that helps us make decisions about our own organizations.

Enterprise cloud computing is a complex topic, and how you look at it depends on many variables. Below I try to outline one typical scenario. Your inputs, and the weight you give to different factors involved in making the decision will vary, but the general paradigm is useful across a wide variety of organizations.

In the interest of full disclosure, I am CEO of a company that sells cloud-based clinical research solutions (OpenClinica Enterprise, OpenClinica Participate). We adopted a cloud model after going through exercises similar to the ones below. Rather than reflecting bias, it demonstrates our belief that the cloud model offers the greatest combination of value for the greatest number of organizations in the clinical research market.

So… Let’s say you’re a small-to-medium size enterprise, usually defined as having under 1000 staff, and you are considering moving your eClinical software technologies to a public cloud and/or to a Software-as-a-Service (SaaS) provider.

Let’s start with the generic move of in-house (or co-located) servers and applications to public cloud environment. We’ll get to SaaS in a bit.


For this exercise, we’ll use the handy modelling tools from Intel’s And we’ll assume you want to run mission-critical apps, with high levels of redundancy that eliminate single points of failure. We’ll compare setup of your own infrastructure using traditional virtualization to a similar one on cloud, based on certain assumptions:

The results for an internal, or “private” cloud are:


The public cloud looks as follows:




Wow. A 26x difference in cost. Looks pretty compelling, right? But not totally realistic – you’re probably not considering building a highly redundant in-house or co-located data center to host just a couple of apps. Either you already have one in place, or are already deploying everything to the cloud. In the latter case, you don’t need to read further.

In the former case, let’s explore the cost of adding several more applications to your existing infrastructure. What are the marginal costs of adding the same amount of computing capacity (12GB of memory, 164GB storage) on top of an existing infrastructure? We can use the same calculator to compute the delta between the total cost of a private cloud with 190GB of memory and 836GB of storage. But here it gets much trickier.

According to the calculator, our 190GB cloud costs $379,324 – the same as the 12GB cloud in the first example! Moreover, adding another 12GB of capacity pushes the cost up to $513,435, a difference of $134,111. However, if we change our assumptions and start with a 150GB cloud, then add 12GB of capacity, the marginal cost is $0.

What we’re seeing is how the IT overhead costs of running your own private cloud infrastructure tend to grow in a discrete, rather than continuous, manner, and the cost of going from one tier to the next is usually very expensive.

Our calculator makes a bunch of assumptions about the size of each server, and at what point you need to add more hardware, personnel, cooling, etc. The exact number where these thresholds lie will vary for each organization, and the numbers in the example above were picked specifically to illustrate the discrete nature of IT capacity. But the principle is correct.

Large cloud providers, on the other hand, mask the step-wise and sunk capital costs from customers by only charging for each incremental unit of computing actually in use. Because these providers operate at a huge scale, they are able to always ensure excess supply and they can amortize their fixed and step-wise costs over a large number of customers.

The examples above show that the actual costs of a public cloud deployment are likely to be significantly lower than those of building or adding to a comparable private cloud. While there’s no guarantee that your public cloud cost will be less than in-house or colocated, market prices for cloud computing continue to become more competitive as the industry scales up.

What is certain however, is that flexibility of the public cloud model eliminates the need for long-term IT capital budget planning and ensures that a project won’t be subject to delays due to hardware procurement pipelines or data center capacity issues. In most cases it can also reduce burden on IT personnel.

Qualitative Advantages

The central promise of the cloud is a fundamental difference in the ability to run at scale. You can deploy a world class, massively scaled infrastructure even for your first proof-of-concept without risking millions of dollars on equipment and personnel. When Amazon launched the S3 cloud service in 2006, its headline was “Amazon S3 enables any developer to leverage Amazon’s own benefits of massive scale with no up-front investment or performance compromises”.

It is a materially different approach to IT that enables tremendous flexibility, velocity, and transparency, without sacrificing reliability or scalability. As Lance Weaver, Chief Technology Officer for Cloud at GE Corporate identifies, “People will naturally gravitate to high value, frictionless services”. The global scale, pay as you go pricing models, and instantaneous elasticity offered by major public cloud providers is unlike anything in the technology field since the dawn of the Internet. If GE can’t match the speed, security, and flexibility of leading public cloud providers, how can you?

What You Give Up

At some level, when moving to the cloud you do give up a measure of direct control. Your company’s employees no longer have their hands directly on the raw iron powering your applications. However, the increased responsiveness, speed, and agility enabled by the cloud model gives you far more practical control that the largely theoretical advantages of such hands-on ownership. In a competitive world, we outsource generation of electrical power, banking, delivery of clean, potable water, and access to global communications networks like the Internet. Increasingly, arguments for the cloud look similar, with the added benefits of continuous, rapid improvements and falling prices.

Encryption technologies and local backup options make it possible to protect and archive your data in a way that gives you and your stakeholders increased peace-of-mind, so make sure these are incorporated into your strategy.

Risk Reduction

The model above is based on the broad economics of the cloud. However, there are other, more intangible requirements that must be met before a change can be made. You’ll want to carefully evaluate a solution to ensure it has the features you need and is fit for purpose, that the provider you choose gives you the transparency into the security, reliability, and quality of their infrastructure and processes. Make sure that data ownership and level of access is clear and meets your requirements. Ensure you have procedures and controls in place for security, change control, and transparency/compliance. These would be required controls for an in-house IT or private cloud as well. One benefit of public cloud providers in this area is that many of them offer capabilities that are certified or audited against recognized standards, such as ISO 27001, SSAE16, ISAE 3402, and even FISMA. Some will also sign HIPAA Business Associate Agreements (BAAs) as part of their service. Adherence to these standards may be part of the entry-level offering, though sometimes it is only available as part of a higher-end package. Be sure to research and select a solution that meets your needs.

External Factors

No matter who you are, you are beholden to other stakeholders in some way. Here are a couple areas to ensure you pay attention to:

  • Regulation – Related to risk reduction, you want to have controls in place that adhere to relevant policies and regulations. In clinical research, frameworks such as ICH Good Clinical Practice and their principles of Computer System Validation (CSV) are widely accepted, well understood, and contain nothing that is a barrier to deploying a well-designed cloud with the appropriate due diligence. You may also have to consider national health data regulations such as HIPAA or EU privacy protections. Consider if data is de-identified or not, and at what level, to map out the landscape of requirements you’ll have to deal with.
  • Data Storage – A given project or group may be told that the sponsor, payer, institution, or regulatory authority requires in-house or in-country storage of data. Sometimes this is explicitly part of a policy or guideline, but just as often it is more of a perceived requirement, because “that’s the way we’ve always done it”. If there is wiggle room, think about if it is worth fighting to be the exception (more and more often, the answer is yes). Gauge stakeholders such as your IT department, who nowadays are often overburdened and happy to “outsource” the next project, provided good controls and practices are in place.
  • Culture – a famous saying, attributed to management guru Peter Drucker, is that “Culture eats strategy for breakfast, every time”. Putting the necessary support in place for change in your organization and with external stakeholders is important. The embrace of cloud at GE and in the broader economy helps. Hopefully this article helps :-). And starting small (something inherently more possible with the cloud) can help you demonstrate value and convince others when it’s time to scale.


SaaS (Software-as-a-Service) is closely tied to cloud, and often confused with it. It is inherently cloud-based but the provider manages the details all the way up to the level of the application. SaaS solutions are typically sold with little or no up-front costs and a monthly or yearly subscription based on usage or tier of service.



When you subscribe to a SaaS application, your solution provider handles the cloud stuff, and you get:

  • a URL
  • login credentials
  • the ability to do work right away

Which leads to a scenario like the following:

A few years ago, you typically had to balance this advantage (lack of IT headaches and delays) against the lack of a comprehensive feature set. As relatively new entrants to the market, SaaS platforms didn’t yet have all the coverage of legacy systems that had been around for years, or in some cases decades. However, the landscape has changed. The SaaS provider is focused on making their solution work great on just one, uniform environment, so they can focus more of their resources on rapidly building and deploying high-quality features and a high-quality user experience. The result is that there is far more parity. Most SaaS solutions have caught up and are outpacing legacy technologies in pace of improvements to user experience, reliability, and features. Legacy providers have to spend more and more resources dealing with a complex tangle of variations in technology stack, network configuration, and IT administration at each customer site.


Furthermore, the modern SaaS provider can reduce, rather than increase, vendor lock-in. Technology market forces demand that interoperability be designed into solutions from the ground up. Popular SaaS frameworks such as microservice APIs mean your data and content are likely to be far more accessible, both to users and other software systems, than when locked in a legacy relational database.

The SaaS provider has the ability to focus on solving the business problems of its customers, and increasingly-powerful cloud infrastructure and DevOps technologies to automate the rest in the background in a way that just works. These advantages get passed that along to the customer in continuous product improvements and the flexibility to scale up and down as you need to, without major capital commitments.


YMMV, but cloud & SaaS are powerful phenomena changing the way we live and work. In a competitive environment, they can help you move faster and lower costs, by making IT headaches and delays a thing of the past.


2015 Future of Open Source Survey Results

Open source software has emerged as the driving force of technology innovation, from cloud and big data to social media and mobile. The Future of Open Source Survey is an annual assessment of open source industry trends that drives broad industry discussion around key issues for new and established software-related organizations and the open source community.

The results from the 2015 Future of Open Source Survey reflect the increasing adoption of open source and highlight the abundance of organizations participating in the open source community. Open source continues to speed innovation, disrupt industries, and improve productivity; however, a reported lack of formal company policies and processes around its consumption points to a need for OSS management and security practices to catch up with this growth in investment and use.

Check out the slides below for survey results.

Reducing friction in patient engagement: an (unconventional) case study

Participate_SCDM_SurveyOur quest for frictionless, electronic patient reported outcomes (ePRO) data capture has us looking for novel ways to engage patients and streamline process. I’d like to share a fun and interesting example of this work, in which we used Participate (the OpenClinica ePRO solution) to engage study subjects at the recent SCDM annual conference.

Our goal at the SCDM conference was to get as many attendees to try OpenClinica Participate as possible. With the vast array of vendors, eye candy, and giveaways, it’s a big challenge to cut through the noise and offer a simple, fun way to engage an audience. The same holds true when engaging patients. With the enormous number of daily distractions, ensuring that your patients can quickly access, fill out and submit well-constructed, simple forms is key to compliance and ultimately, better data.

I built the form, shown here, in OpenClinica and enabled access to it via a custom URL, a new feature in our latest release.

Attendees filled out the form, sprinkled with fun health habit questions, then captured information to allow us to draw their names to win Fitbits and other giveaways. We were able to use this data and update our graphs to give the participant a view of how they stacked up with their peers—cool!

Imagine if patients could view a visual representation of the study they are enrolled in – see the parallels and possibilities?


Who says ePRO and patient engagement can’t be fun?