OpenClinica Central User Training – Brussels – October 15-18

Don’t miss OpenClinica’s Central User training course in Brussels, from October 15 – 18!

Register now, seats are filling up!

Register for Training

About the course:

Our most popular course, OpenClinica “Central User” Training delivers a 4-day intensive experience for people who need to learn about using OpenClinica from all types of user perspectives. This course is ideal for someone who wants to become an OpenClinica super user or will be responsible for training/teaching/supporting their colleagues. Classes are highly interactive and incorporate exercises and tailored instruction. We also regularly organize private classes as needed.

Register at:

https://www.openclinica.com/open-enrollment-training

We hope to see you in Belgium!

Warm Regards,
The OpenClinica Team

OpenClinica and TraIT: A Dutch National Research Infrastructure

Is it possible to set up an IT infrastructure for translational research for an entire country? The Dutch Translational Research IT (TraIT) project (http://www.ctmm-trait.nl/) believes it is. Admittedly, The Netherlands is not exactly the same size as China or the US, but nevertheless already 26 partners from industry and academia to collaborate in this consortium to organize, deploy, and manage a nationwide IT infrastructure for data and workflow management targeted specifically at the needs of translational research. It includes the Dutch university medical centers, notable companies like Philips, and charities such as Dutch heart and cancer foundations.

At its outset, TraIT worked closely with selected translational research projects and scientists, piloting potential solutions with real research data from these projects. This work resulted in the selection and implementation of central TraIT services for clinical data gathering (OpenClinica) and image archival and retrieval (NBIA). TraIT has now reached a very interesting phase where the first IT solutions put in place in each of the four major domains of translational research (clinical, imaging, biobanking and experimental (any-omics)) are starting to flourish.

Word is quickly spreading about the TraIT infrastructure available. In particular, OpenClinica is taking off very well with amazingly little advertisement: currently the TraIT installation (OpenClinica.nl) contains 47 studies with 256 users representing 77 institutions, and is still growing rapidly as can be seen in the following graph:

Uptake of OpenClinica in TraIT

Based on the input obtained from users, we decided to augment some of OpenClinica’s capabilities, in particular for data loading. Obviously, the improvements are made available to the community whenever possible. For further enhancements, TraIT and OpenClinica, LLC entered into a partnership focusing (initially) on improvements in the areas of role-based security, linking to external (imaging) data archives, and data import/export. Hopefully, the fruits of this collaboration will soon be available to the entire OpenClinica community.

The next challenge faced by the TraIT project is integrating the clinical data from OpenClinica with molecular profiling data, which is needed to address the key question in translational research: how to correlate the variation in disease phenotype to variations in underlying biology. Another open source solution has been selected for this purpose: tranSMART, a translational workbench and data integration environment supported by several major Pharma and research consortia. The open source tools selected promise to be a powerful combination: data collected in OpenClinica can be further shared and analyzed in the tranSMART environment.

View slides from a presentation on TraIT delivered at the 2013 OpenClinica Global Conference.

Jan-Willem Boiten
Project Manager
TraIT at the Center for Translational Molecular Medicine (CTMM)

Synchronizing OpenClinica Instances: Another Option for Using OpenClinica in Disconnected Settings

While tablet software maker Mi-Co is showcasing an integration of their Mi-Forms tablet-based forms software with OpenClinica that can be used in “offline” settings, elsewhere within the OpenClinica community, Raymond Omollo and Michael Ochieng have developed a separate option for using OpenClinica in settings without internet connectivity. Their method synchronizes multiple locally deployed instances of OpenClinica with a central OpenClinica database. Michael and Raymond recently presented their work at the OC13 conference. You can access their presentation slides here to see how they address key issues such as synchronization, back-ups, encryption, and user training.

Synchronization Flow Chart
Synchronization Flow Chart

While working for Drugs for Neglected Diseases initiative (DNDi), Michael and Raymond devised this approach for a WHO study of Buruli ulcers in West Africa (Ghana and Benin). The study, which is ongoing as of the date of this post, is a randomized controlled trial comparing the efficacy of 8 weeks treatment with clarithromycin and rifampicin versus streptomycin and rifampicin. It involves 430 subjects across 5 sites. The participating sites have limited or unstable internet connectivity, so a solution is needed that provided timely, auditable, and quality data entry given this constraint. A positive byproduct is enhancing the capacity of these disconnected sites to utilize EDC.

As they say, necessity is the mother of invention. And open source makes it easier for people to believe that what is necessary can in fact be accomplished. Kudos to Raymond and Michael for devising a solution that works for them. Perhaps it may work for others as well.  If you’d like to access the source code and documentation for their work, you can download these from the OpenClinica Tools and Tips page (scroll to bottom).  You can reach Raymond and Michael on the OpenClinica Developers mailing list: developers@openclinica.org.

– Ben Bauman

More About DNDi

Headquarted in Geneva, DNDi is a global organization that develops safe, effective, and affordable treatments for neglected diseases. The neglected diseases that DNDi tackles afflict many of the world’s poorest people (Malaria, Leishmaniasis, Chagas disease, Sleeping Sickness, Paediatric HIV, Filaria). DNDi’s goal to develop 11 to 13 new treatments by 2018. More at www.dndi.org.

Webinar: Tablet-based Offline EDC for OpenClinica – July 24

Offline Data Capture for OpenClinica – Demo of Mi-Forms Tablet Integration with OpenClinica

Date: July 24, 2013
Time: 2:00PM – 3:00PM EST

Attend this webinar to see, first hand, the use of tablets in offline, disconnected settings to capture and verify CRF data, and transmit them back into OpenClinica. See how the Mi-Forms/OpenClinica integration allows for easy design, deployment and verification of data at the point of capture.

RegisterButtonAt this webinar you’ll discover how to:

  • Enable multi-site offline data capture
  • Reduce query rates & speed trial completion
  • Cut clinical trial costs with mobile data capture

Presenters:
Ben Baumann, OpenClinica COO
Chris DiPierro, Mi-Co Director of Software Development
Gautham Pandiyan, Mi-Co VP of Sales & Marketing

OC13 Wrap Up – The Fruits of an Awesome Community

DSC02823It’s hard to believe that OpenClinica’s Global Conference, OC13 happened one week ago. What a memorable experience! Excellent sessions, great workshops, and an amazing Boston Harbor Dinner Cruise–here’s a recap:

P6210325The Highlights

Doug Bain delivered a insightful keynote presentation that challenged attendees on how to think about about patient engagement in today’s clinical trials. The discussion looked at the use of social media and the many systems and websites such as WebMD, PatientsLikeMe, etc., that are regularly referenced by patients and how this trend is setting new standards for communication.

DSC02816The multitude of OC13 sessions were delivered by an incredibly diverse background of presenters. With presenters from Africa,  Netherlands, Germany and Japan and wide representation from both industry and academia, a wide breadth of relevant, helpful and interesting topics were covered.

cruise1

Visit the conference page to view presentation slides.

I will be posting photos on Facebook highlighting the event. If you are not currently linked to our Facebook account, please “like” us and feel free to post and share your OC13 experiences.

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Thank you for attending and making OC13 a great event! Until next year!

– Rob

Doug Bain – OpenClinica Keynote address – Boston, 6/21/2013

Doug Bain - CEO and Co-Founder

Doug Bain is proud to be invited to give the keynote address at the annual OpenClinica User group meeting schedule for Friday 21st June in Boston – just prior to the annual DIA 2013.

“As a former developer of an open source EDC solution,  I have the greatest respect for the work completed, and success that OpenClinica have had in recent years.   It is very difficult to get an Open Source solution off the ground, and to gain a critical momentum to move the solution forward.   Despite working within a tightly regulated environment, with an audience often verging on the conservative when approaching technology,  the platform has evolved and extended with a solid user base.

One of the areas I will be focusing on during my keynote address is the field of Patient Engagement.  In the development of technologies, we have often fallen back to a role of attempting to replicate a paper world.  To some extent, we have done this with CRFs.  We have stuck the ‘e’ on the front to create eCRF’s…  but have we really changed how clinical trials function?

I look forward to meeting the OpenClinica community, and to discuss the opportunities that exist for reaching out and involving patients more intimately in research.”

Doug Bain, CEO, eClinicalHealth Limited.

Kool-Aid > Coffee

Over the last few weeks, the OpenClinica LLC team has spent a lot of time on future-based thinking. We have been taking an introspective approach and asking ourselves difficult questions. What kind of value should we deliver? What kind of community do we want to develop? What exciting possibilities exist for those who use our products? How do we get there and how do we start? Why are we spending time thinking about such heady things? Simply put, we are laser-focused on taking OpenClinica into the next generation.

As OC’s Software Applications Manager, I am uniquely positioned at the confluence of OpenClinica’s Ghosts of Software past, present, and future. In one sense, we are challenegd with a tangled web of brittle legacy code which, while stable, needs to be refactored. As such, we face the daily conundrum of “bandaid and patch” vs. “rip and replace” whenever we encounter unscalable and unsavory implementations. We literally make these decisions every day as we work on the new and improved Print CRF. The “New Print CRF” Kool-Aid has officially replaced our coffee machine and we are fully invested in a more modular architecture, which makes it hard to not dig in and REFACTOR ALL THE THINGS!

 

 

 

 

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In addition to the above, we are in the midst of a tool suite change. We are moving away from Mantis as our IssueTracker and have been making the transition over to GreenHopper for JIRA for tracking our projects. Cal touched on this in his last email, as well. This process is taking more time than we originally anticipated, but for good reasons. First, we are busy getting 3.1.4 wrapped up and release ready. Second, we have been growing our staff and recently welcomed our new DevOps/Release engineering guru, Rob M. Rob has been carefully architecting a scalable role-based SSO solution for OpenClinica LLC’s internal tool suite, among many other things. Rob’s top priority is to make JIRA accessible and secure to allow for maximum visibility into our development process. We hope to continue growing our staff this summer to give us some much needed development horse power.

“Mantis seems to work fine, why change tools?” you may ask. JIRA provides vital project metrics and, more importantly, clear audit logs, traceability, and valuable integrations which help us cut down on documentation and release overhead and communicate more clearly with you, our community.

This is all a means to an end, friends! We realize we need to make the participation process easy, transparent, and engaging in order to foster a stronger community. Our community is what drives our innovation. You create our mission. You push our product forward. You are the reason I come to work every day. Just like you, I am passionate about what we are doing with OpenClinica, but passion doesn’t count for much without a proper bearing to know where the next step is. It is up to all of us to author our product’s story. Together, we are greater than the sum of our parts and together we have the power to change the world of clinical trial EDC.

OC13 Boston – Less than a month to go!

Please excuse our excitement! There’s less than one month to go for OC13 — if you haven’t registered, now is the time to do it. Come learn about the world’s most widely used clinical trial software. All are welcome — whether you’re new to OpenClinica or already a seasoned expert.

  • Improve your effectiveness
  • Hone your skills at workshops
  • Hear case studies and best practices
  • Establish valuable connections

We looking forward to seeing you in Boston!

Odyssey Cruise
After a jam-packed day of presentations, tutorials, case studies and workshops, enjoy a relaxing dinner and drinks aboard the Odyssey. Explore Boston from the vantage point of this historical harbor. Sign up.Odyssey Cruise Ship

The Open Source Way

The OpenClinica LLC team subscribes to a core set of values we do our best to live and work by in everything we do. They are primarily based around what it means to us to be open source. In the spirit of living by the first one (be radically open), here they are!

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At OpenClinica, we believe that a successful business depends on a successful and growing open source community. We aspire to be part of a community that is as accomplished as Linux, Drupal, and Apache. We want to achieve a similar level of innovation, quality, collaboration, and transparency. To travel this journey (and build a great product along the way!) we constantly strive to put in practice the following values:

  • Be radically open.
  • Release early and often. Not always production releases, but find ways to get code in the hands of users and testers.
  • With enough eyeballs, all bugs are shallow. Follows from release early and often.
  • Keep barriers low!! For distribution, evaluation, adoption, contribution. Question complexity. Some is necessary but favor simplicity where at all possible.
  • If you need it, then build it. Or find it (see next one).
  • Share and re-use other’s work. Avoid not-invented-here (NIH) syndrome. Somebody has done it before. Or, someone has done something similar but not thought of using it for what you need. Here’s where radical innovation and gigantic leaps forward happen.
  • Keep at it. There are no substitutes for persistence and perspiration.
  • Reward good ideas and good contributions. Let leadership and accountability thrive.
  • Maximize participants’ strengths.
  • Avoid community anti-patterns.
  • Make it yours. You are your personality.
  • Most of all, find your passion and let your love for what you do shine through!

There are hundreds, if not thousands of articles, presentations, and academic papers on what makes open source communities work. Here are a few that best articulate the values described above:

Eric Raymond, The Cathedral and the Bazaar. It all started here. Read the summary or the full paper.
Matthew Mascord, How to Build an Open Source Community
Joel Dietz, How to build a vibrant open source community
David Neary, Open Source community building: a guide to getting it right
Jonathan Corbet, How to destroy your community
David Nalley, Leadership in open source communities
Stephen Walli, Open Source: No one is working for free
Ben Baumann, OpenClinica Community Surpasses 10,000 Members …and oh yeah, what is this open source thing?

 

 

A Fresh Perspective on Upcoming OpenClinica Events

GrassGuy_KickedBackWhat a great time of year! The sun is out and the flowers, trees, and grass are blooming. There is no better time to spread the news about our fresh perspective on electronic data capture.

What are we up to?

  • We’ll be at SCT – Society for Clinical Trials 34th Annual Meeting in Boston next week, talking with over 650 professionals dedicated to the design, conduct and analysis of clinical trials.
  • Going to Shanghai! We will be holding our Central User training in Shanghai, China from May 28-31. This follows the DIA China Annual meeting, where OpenClinica was featured in numerous presentations.
  • We hope to see you at the OC13 Global Conference in Boston on June 21. We have an exciting lineup of great workshops, sessions, demos and training classes–there is something useful for everyone. We are really looking forward to the Boston Harbor Dinner Cruise for a chance to kick back after the event and visit with our OpenClinica friends. Sign up! You don’t want to miss this.
  • Capping off our spring events and immediately following OC13 is DIA 2013 in Boston, June 23-27. We are bracing ourselves for 7,000 life science professionals converging on our booth to take in our fresh perspective and enjoy some espresso, demonstrations and some very competitive games of cornhole (yes, this is a real game!). We have some great giveaways and prizes in an outdoor-themed space. Will you be there? If so, stop by Booth #122 and have some fun.

OpenClinica Next Generation

EnterpriseDo you want to boldly go where OC is going? Engage! Check out Nick Sophino’s blog on next generation OpenClinica. This is where to find information on prototype design and development for OpenClinica Next Generation. Nick is going to be showing off this work at OC13 so be sure to check out his session!

Throw a few steaks on the grill and kick back and enjoy the season. And, remember to always look for a fresh perspective.

Warm Regards,
Rob