New eCRFs (Colleague Revelation Forms)

OpenClinica has welcomed several new team members over the last few months. We’ve collected some eCRFs (Collegue Revelation Forms) to introduce them!

Name: Paul Bowen
Title: Product Owner
Responsibility: I bridge the gap between our stakeholders and our engineering team to ensure that we build the features into OpenClinica that are needed most.
Background: Prior to joining OpenClinica, I spent ten years at Quintiles/Outcome Sciences developing an EDC platform for late phase studies. I also spent one year at Clinical Ink working on a patient engagement app.
What I love about research: I like being a part of something that is making people’s lives better in a significant way.
What I love about technology: Technology provides us with many new options to improve the way we do research. Working to figure out the best solutions is a fun part of this job.
What I love outside of work: When the weather is nice, my girlfriend and I like taking long walks with our dog. When it’s not as nice, we like watching sci-fi TV and movies.


Name:
 Bryan Farrow
Title: eClinical Catalyst
Responsibility: I’m the link between the data management community and OpenClinica. It’s my job to distribute news about our products and services to data managers who’ve been looking for solutions to industry-wide problems like integration and ease of use. Just as importantly, I bring unmet challenges back to our incredible team of developers and customer success professionals so that we can find a solution.
Background: Prior to joining OpenClinica, I spent five years at DrugDev, learning how just how much technology can affect the duration, cost and experience of running a trial. Prior to that, I was responsible for physician and patient communications at Boston Children’s Hospital.
What I love about research: The journey and the destination. Asking questions, devising ways to get an answer, and analyzing evidence are thrilling. With clinical research, we get to do all that with the aim of improving lives.
What I love about technology: For me, technology comes down to problem-solving. If you’re curious and persistent, you can always find a better way. And it’s so gratifying when you do.
What I love outside of work: My family above all. I love being a father to my two kids and a partner to my incredible wife. But when I need some “me time”, I usually reach for a book or journal dealing with philosophy. That was my major in college, and I’m still enamored with the power of logic and the gravity of big ethical and political questions.

Name: Brittany Stark
Title: Project Manager
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent 4 years in the Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center, working with phase 0-IV clinical trials in oncology. During this time, I gained experience as a Clinical Research Coordinator, Regulatory Affairs Specialist and later Clinical Trials Staff Educator. Prior to this, I spent over 4 years working in academia at the University of Kentucky (in a Human Behavioral Pharmacology and Clinical Psychology Lab) and later at the University of Maine (teaching SPSS as part of a Research Methods and Designs Course Lab).
What I love about research: The potential to advance our understanding of the world we live in and change lives for the better.

Name: Chris White
Title: Customer Success Team Lead
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent two years in the consulting industry working with many different types of software. Prior to that, I spent 14 years creating positive customer experiences with two successful start-ups, helping to build their client focused operations.
What I love about research: There is still part of me that is the seven-year-old Calvin (from Calvin and Hobbes), always asking questions, wanting to know and understand the wide world around me.

 

 

What prevents you from doing (more) ePRO?

Patient-reported outcomes give us insights that no clinical assessment, imaging study and lab report can. For subjective measures, such as mood or energy level, there’s often no other source. But common methods of collecting PRO, from paper diaries to provisioned devices, pose real barriers. We want to know which ones you’ve faced. Tell us by completing the form below. We have more to say on the topic, but we want to start with your experiences!

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

When it comes to your assessing your trial technology, your data managers, study coordinators, Investigators and senior leaders are all study subjects.

In the previous post, I described the difference between efficacy and effectiveness, an increasingly important concept in clinical research and healthcare. After stressing the importance of effectiveness research to health policy planning and patient decision-making, I summarized seven criteria for identifying effectiveness studies. Finally, I asked whether these criteria could be re-purposed beyond a medical intervention to inform how we measure the effectiveness of software systems used to conduct clinical trials.

Is it possible to assess clinical trial software through the lens of effectiveness, as opposed to just efficacy?

I believe that it’s not only possible, but crucial. Why? We all want to reduce the time and cost it takes to deliver safe, effective drugs to those that need them. But if we don’t scrutinize our tools for doing so, we risk letting the status quo impede our progress. When lives are on the line, we can’t afford to let any inefficiency stand.

In this post, I adapt the criteria for effectiveness studies in clinical research into a methodology for evaluating the effectiveness of clinical research software. I limit the scope of adaptation to electronic data capture (EDC) systems, but I suspect that a similar methodology could be developed for CTMS, IVR, eTMF and other complementary technologies. If I open a field of inquiry, or even just broaden one that exists, I’ll consider it time well spent.

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)

Are you measuring all the relevant outcomes of your clinical trial technology?

For pure pathogen-killing power, it’s hard to beat a surgeon’s hand scrub. Ask any clinician, and she’ll tell you how thoroughly chlorhexidine disinfects skin. If she’s a microbiologist, she’ll even explain to you the biocide’s mechanism of action–provided you’re still listening. But how would the practice fare, say, as a method of cold and flu prevention on a college campus? Your skepticism here would seem justified. After all, it’s hard to sterilize a cough in the dining hall.

Efficacy and effectiveness. It’s unfortunate their phonetics are so close, because while the terms do refer to relative locations along a continuum, they’re the furthest thing from synonyms, as the ever accumulating literature on the topic will attest.

In this post and the one that follows, I’d like to offer some clarity on efficacy vs. effectiveness and illustrate the value that each type of analysis offers. If nothing else, what emerges should provide an introduction to the concepts for those new to clinical research. But I have a more speculative aim, too. I’d like propose standards for assessing trial technology through each of these lenses. Why? Because while we’ve been asking whether a particular technology does what it’s explicitly designed to do, as we should and must, we may have forgotten to ask a critical follow-up question: Does it improve the pace and reliability of our research?

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)

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:

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  • 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 openclinica.nl 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.