Countdown to OC18

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“Can we get personal?”

That’s the question motivating today’s most innovative research. Whether it’s an RCT with a biomarker cohort or an observational study based on real-world evidence, we’re seeing the “data funnel” widen to encompass much more about the participant than their diagnosis. Genomic medicine is just one example. Factors including phenotypic traits, diet, and lifestyle, among others, are all counting for more in studies that seek to match the right therapy with the right patient.

This year’s theme is a recognition of this important new paradigm. But it’s not meant to constrain. How are you adapting to the complexity of new and expanding data types? How do we make the tools of data management as personal and precise as the results we’re seeking?

We’ll explore these questions and more as data gets personal at OC18! 

Venue

Le Méridien Cambridge-MIT
20 Sidney Street
Cambridge MA 02139
+1 617-577-0200
Reserve a room at Le Meridien
Browse nearby hotels

Program

Below are sessions and workshops planned as of September 11, subject to minor updates. Interested in presenting? Submit your abstract here.

Monday, October 15

Breakfast, lunch, and all workshops will take place in or adjacent to the Hunsaker Ballroom on the 3rd floor of the hotel.

9am to 10am

Breakfast and registration

10am to 11:50am

Morning Workshops (choose one)

OC4 Architecture and Integration

Moving from genomes to biomarkers to disease risk models and personalized treatment requires more than one big dataset: it requires the integration of data from multiple systems that are secure, geographically separated, and disparately schematized. Here’s where OpenClinica shines. Get a grip on all the API tools available to build the full data picture you need.

Learn more about this workshop

OC4 is a multi-tenant cloud platform that embraces open source, automates provisioning, and offers validated traceability, massive scalability, and high-grade security. By breaking from the model of a monolithic application and turning to a microservices model built for the cloud, we’re able to deploy more user-friendly, productivity-enhancing features quickly and reliably.

Meanwhile, we continue to expand the ways to make it possible (not to mention reliable and easy) for users and developers to interact with their instances in a programmatic way. This can mean anything from data loading to more meaningful integrations of applications common to the clinical research environment. With CTO Krikor Krumlian as your guide, learn how to create new efficiencies with workflow integrations relying on OpenClinica’s proven RESTful architecture.

Graphical Reporting with OC Insight

Data managers need quantitative (and often visual) snapshots of their study data–ones that can be understood at a moment’s glance. Historically, through, the burden of creating those snapshots has fallen to the resident Excel expert, who often needs hours and sometimes days to create reports that are almost immediately out of date. OpenClinica developed Insight to replace this “extract-format-repeat” process. Insight taps your study database directly to create up-to-the-hour line graphs, bar charts, scatterplots, pie charts, and more, allowing you to spot trends and share reports at will. In this workshop, you’ll learn how Insight works and how to create and share data dashboards.

See Insight in action

12pm to 12:50pm

Lunch

1pm to 2:50pm

Afternoon Workshops (choose one)

Validating OpenClinica

Do you know your IQ from your OQ? Wondering if you’re living in a traceability matrix? We offer a wealth of resources designed to make it easy for you to achieve, maintain, and demonstrate compliance. But navigating it all can be daunting. Attend this session to make the most of our compliance support.

Voice of the User

The users of OpenClinica tackle challenging clinical research problems, manage vast amount of data, and make difficult decisions to advance research and improve patient outcomes. A web interface needs to make these tasks easier, not more difficult. Welcome to User Experience, or (UX). UX is not just an industry buzzword at OpenClinica, but a cornerstone of our software development. We sit side-by-side with our users to understand their workflow, conduct in-depth interviews to discover their needs and pain points, and perform testing to gather feedback on designs.

In this workshop, we will highlight some of our UX efforts, and invite you to continue to share your insight with us through a series of fun and interactive games.

3pm to 4:50pm

Demonstrations (choose one set)

OpenClinica Core and Modules

Live, interactive demos of each component of our solution: our core data capture and management platform; OpenClinica Randomize; OpenClinica Participate; and OpenClinica Randomize.

Clinical trial management with Bio-Optronics

“Smarter Front Ends” with Vigyanix

Easy, powerful software is really just the means: at OpenClinica, our aim is better data capture and management.
That’s why we proudly partner with companies who share that mission and are willing to work with us and our
clients to make it a reality. This workshop gives you the chance to learn from leaders at two such partners. See how our peers at Bio-Optronics help you achieve end-to-end trial management through integration with OpenClinica. Then learn how to make your workflow visions reality with front-end customization from Vigyanix.

Tuesday, October 16

Breakfast, lunch, and all sessions will take place in or adjacent to the Hunsaker Ballroom on the 3rd floor of the hotel.

8am to 9am

Breakfast

10am to 10:50am

“Running Tomorrow’s Trials Today on OC4” with Cal Collins, CEO 

11am to 11:50am

Morning sessions (choose one)

Form Magic

Astound your sites and participants with forms as intelligent as they are dazzling. We’ll share examples of form crossing, auto-completing, score calculating wizardry you can use to make your eCRFs more powerful and engaging.  

Your Site Engagement Starter Kit

After participants, the hard-working investigators, coordinators, and clinicians at your trial sites are your most valuable study resources. How do you keep your study top of mind with this key audience? How do you instill a sense of excitement and ownership that will translate to the best possible enrollment, protocol compliance, and data entry and query resolution performance? Attend this session to learn strategies and tactics you can implement today, using free Web-based tools and resources. You’ll learn: how to build and send high-impact, metrics-driven, customized emails to all site personnel; bring the science of your study to life with video; make procedures and processes clearer; and recognize your high achievers. A more vested, happier, and productive trial team awaits!  

12pm to 12:50pm

Lunch

1pm to 1:50pm

Customer Case Studies

OpenClinica customers are innovators and problem-solvers. After lunch, we’ll turn the spotlight on them to hear their stories of the role OpenClinica played in recent studies.

2pm to 2:50pm

Afternoon sessions (choose one)

Is eConsent Right for Your Study?

Informed Consent is a multifaceted process that goes far beyond obtaining a signature. Genuine consent involves providing potential participants with adequate information about the research to allow for an informed decision to participate, facilitating and verifying comprehension of the information, and allowing adequate opportunity for questions and consideration. 

Electronic informed consent (e-Consent) must accommodate all these requirements. Done well, e-Consent can maximize patient understanding, engage non-English speakers with multilingual tools, improve documentation and reporting, and standardize the consent process across sites, all while reducing cost and administrative burden. Attend this session to learn how to determine the suitability of e-Consent in light of your study’s setting, participant profile, and indication (among other attributes), as well as the best way to adapt the principles of fully informed consent in its usual, paper-based context to one where the process is electronic.

 

Making the Leap from OC3 to OC4

Change isn’t always easy, but often worthwhile. First-time users of OC4 do face a learning curve, with a new form engine and study building module presenting new skill sets to master. But the power, possibilities, and efficiencies gained represent a tremendous “ROI” on the time spent by users to develop these skills.

Of course, like any change in the real world, bumps are inevitable. So are unexpacted delights. In this session, hear from some of your peers on what to anticipate when making the transition from a great solution to our best yet.

3pm to 3:50pm

Afternoon sessions continued (choose one)

CDASH: What Is It, and What Is It Good For?

Data silos aren’t just frustrating and inefficient; they’re barriers to getting much-needed treatments to patients quickly. Clearing these barriers is a multi-faceted initiative that involves standardizing processes and terminology. Today, CDISC (The Clinical Data Interchange Standards Consortium, formed in 1997) provides the most centralized leadership of this initiative.  CDASH (Clinical Data Acquisition Standards Harmonization) represents one of its key tools for allowing data to “speak the same language.” The CDASH model includes standardized form and item names, input conventions, and harmonized codelists to provide clearer traceability of data. Attend this session to review instructive examples and learn where to find resources for bringing your studies into compliance with CDASH.

Handling Data in a GDPR World

This past May, the EU enacted sweeping new laws, called the “General Data Protection Regulation,” which redefine the handling of personal data. GDPR has far-reaching implications for all entities collecting or storing data, even those beyond the physical borders EU/EEA, and stiff penalties for non-compliance. This session will provide an overview of GDPR and the principles and requirements which pertain to data subjects, data controllers, and data processors. Emphasis will be placed on breaking down GDPR into practical takeaways that can be implemented for groups running clinical studies.

4pm to 4:50pm

Afternoon sessions continued (choose one)

What’s New at the FDA? A Review of Recent Guidance

If you’re looking for guidance on procedural and technological compliance, the FDA has you covered. But if you’re looking for specifics and how-to’s for implementation, well, you’ll need to ask around. Your team at OpenClinica is a great source of intepretation and insight. In this session, we’ll present recent FDA guidance in plain language, without simplifying the requirements for auditor-friendly practices and system standards. 

How to Secure Your Clinical Data

In the wake numerous high profile data breaches, data security is a hot topic these days. Security is not something that can be addressed by software features alone–adequately securing your clinical data is a complex undertaking requiring numerous technical and procedural safeguards across varied technology systems and business functions. This session will provide a framework for considering risk and ensuring security of your clinical research data in a holistic way, with an emphasis on practical steps that can be taken.

Keynote (October 16)

We are honored to welcome MIT professor and MacArthur genius grant receipient Dr. Regina Barzilay for a talk on the clinical applications of deep learning.

From every pixel of their MRI scan to each word in their medical chart, patients bring a wealth of data to their clinical trial or care journey. We can learn from this data? It may not be obvious to human minds, but neural networks trained on historic data and outcomes may be capable of producing models that predict, for new patients, everything from future morbidity to treatment fit. 

You don’t want to miss this fascinating discussion.

Dr. Regina Barzilay

Regina Barzilay is a Delta Electronics professor in the Department of Electrical Engineering and Computer Science and a member of the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology. Her research interests are in natural language processing and the applications of deep learning to chemistry and oncology. She co-directs the pharmaAI consortium at MIT. She is a recipient of various awards including the NSF Career Award, the MIT Technology Review TR-35 Award, Microsoft Faculty Fellowship and several Best Paper Awards at NAACL and ACL. In 2017, she received a MacArthur fellowship, an ACL fellowship and an AAAI fellowship. She received her Ph.D. in Computer Science from Columbia University, and spent a year as a postdoc at Cornell University.

Night LIFE

Join your peers for an evening of elegance and education on October 16. With wine, beer, or sparkling beverage in hand, explore the incredible Hall of Human Life at the Boston of Museum of Science. Then adjourn to the top of the museum for an “Oktoberfest” themed German dinner as you take in the city’s radiant, autumn skyline.

Beverage Menu

Kenwood Yulupa Chardonnay & Merlot

Stella Artois

Harpoon IPA

Sam Adams

Soft drinks

Water

Sparking Water

Dinner Menu

Wood Fire Flàmmeküeche (Tarte Flambee) – Fromage Blanc, Speck, White Onions, Gruyere Cheese

German Cured Meat Platter – Black Forest Ham, Speck, Marinated Vegetables, Bavarian Mustard, Pumpernickel –

Wurst Salat – Lyoner (German Sausage), Shaved Onions, Gruyere

Kartoffle Soup and Wurst “Potato Soup and Sausage”

Veal Weisswurst and Pretzel – House Made Bavarian Mustard

Beef Ribs Goulash “Sauerbraten” – Spätzle, Parsley

Braised Sauerkraut “Choucroute Garnie” (Alasatian) – House Made Beer Sausage, Chicken Weisswurst, Pork Belly, Potato, Spicy Mustard

Pork Schnitzel – Potato Salad, Marinated Cucumber

Super User Training (October 17, 18, and 19)

Over three days of interactive learning, master the full capabilities of OC4 for each user role (data manager, monitor, CRC). Topics will include:

System Overview

Creating a Study

Building Forms

Testing & Publishing

Creating sites and users

Entering, querying, and managing data

Pricing

Amounts shown are USD. The evening event at the Museum of Science is included with registration. Reserve early and in groups for the most savings.

Sessions and Workshops (October 15 and 16)

# of attendees Total
1 $400
2 $750
3 $1050
4 $1300
5 $1500

Super User Training (October 17, 18, and 19)

# of attendees Total
1 $1500
2 $2900
3 $4200
4 $5400
5 $6500