OC24: New Roads to Better Data Faster

Virtual Conference: June 10 - 11
Virtual Workshops: June 12

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We’re going virtual!

We are switching OC24 from an in-person to a free virtual event. While we have historically done these events in-person, embracing a virtual platform opens up exciting opportunities for broader participation, allowing individuals to engage with greater flexibility and convenience.

While this shift will bring some changes, our core objectives remain the same — to facilitate meaningful connections, foster learning, and elevate the standard of clinical trial practices.

The timing of OC24 remains unchanged. The event is free to our customers. Registration is required.

Our main conference starts Monday, June 10 at 11:30 am and concludes Tuesday, June 11 at 4:00 pm.

Check out the agenda and featured speakers!

Join us for two or three days packed with professional development!

“As a seasoned attendee, I’ve witnessed first-hand the value of this conference. From inspiration to new ideas to practical solutions, I’ve learned many useful things every time. Looking forward to more!

Virtual OC24 is free to our customers. Registration required.

Agenda

Main conference & workshops available separately or together.

Conference (June 10 & 11)Workshops (June 12)

Conference

Monday & Tuesday | June 10 – 11 

OC24: Unlocking Progress: New Roads to Better Data, Faster

Day One: Monday | 8:50 am – 3:10 pm | Eastern

8:50 – 9:00 am

Welcome & Housekeeping

Quick welcome & things to know before we dive into our first-ever virtual conference! We can’t wait to see you!

9:00 – 9:45 am

Keynote: Unlocking Progress: New Roads to Better Data, Faster!

To kick off our conference, we will delve into the latest advancements in unlocking progress towards better data, faster. We’ll explore innovative features and unveil our roadmap for enhancing data accessibility and efficiency. From cutting-edge technologies to streamlined processes, discover how we’re revolutionizing data management to propel your organization forward.

Highlights include

• Gain insight into the latest features designed to expedite data workflows and enhance productivity.

• Understand the strategic roadmap for future developments, empowering you to anticipate and adapt to upcoming enhancements.

• Explore practical strategies for leveraging new tools and approaches to optimize data management processes within your organization.

9:50 – 10:35 am

Customer Case Study: Using OpenClinica for a Remote-Managed Large-Scale Trial & Complementing it with In-House Software

ASCEND PLUS is a randomized clinical trial designed to investigate whether oral semaglutide protects against heart attacks, strokes and circulatory problems compared to placebo, in 20,000 participants with type 2 diabetes. At the Clinical Trial Service Unit within Oxford Population Health, we previously developed custom software for all our trials. However, in ASCEND PLUS, we opted to use OpenClinica to expedite the process. Notably, the trial is managed remotely, eliminating the need for in-person clinic visits. Participants can conveniently complete forms online, or study nurses can do so during telephone or video call interviews with participants. The study medication is then dispatched to participants’ homes by mail. While we effectively utilized OpenClinica’s features, we also developed several in-house software components to complement our approach.

Learning Objectives

• Dividing participants into Participate and Non-Participate cohorts and reconciling the different pathways

• Progressing the participant through different stages of the trial in an automated manner.

• Common issues we faced and how we used Insight to track, report and rectify them.

• Using OpenClinica’s APIs for two-way data exchange.

• Using Insight and APIs to make data exchange with OpenClinica more efficient.

10:35 – 10:40 am: Break

10:45 – 11:30 am

Unlock the Full Potential of Insight: Best Practices for Designing Comprehensive Dashboards

Discover how to unlock the full potential of your Insight toolbox with insider tips from the experts who built it. In this session, we’ll cover best practices for designing powerful dashboards that provide actionable insights, enabling informed decision-making and enhancing overall efficiency in clinical research. From built-in reports to custom report creation and easy reuse across studies, learn how to leverage Insight to its fullest extent. We’ll also show you where to find everything you need to know about your Insight database and how purpose-built technology can do the heavy lifting for you. Don’t miss this opportunity to elevate your Insight game and revolutionize your clinical research workflows.

Learning Objectives

• Identify the built-in reports available with every study and understand how to leverage them effectively.

• Explore resources for accessing comprehensive information about your Insight database.

• Discover how purpose-built technology can automate tasks and streamline processes, saving time and effort.

11:35 am – 12:20 pm

Customer Presentation: Informing Real-Time Treatment Decisions using EDC Data Algorithms

Traditional clinical trials often adhere to a “one drug fits all” approach, which limits the ability to tailor treatments to individual patient needs. The I-SPY 2 Breast trial represents a paradigm shift by using personalized medicine to optimize drug efficacy and minimize toxicity. This session will explore how the I-SPY 2 trial leverages biomarker subtypes and real-time data analysis to adapt treatment pathways for breast cancer patients.

Participants will learn about the innovative use of tissue analysis results entered directly into OpenClinica to randomize patients to the most appropriate study drug arm based on their biomarker subtype. The session will detail how Electronic Data Capture (EDC) algorithms continuously evaluate MRI and pathology results, providing personalized treatment recommendations that allow clinicians and patients to adjust the treatment plan in response to real-time outcomes. This adaptive approach ensures that patients receive the most

Learning Objectives

• Understand the limitations of traditional “one drug fits all” clinical trials

• Explore the I-SPY 2 trial methodology

• Evaluate the impact of personalized treatment pathways on clinical outcomes

• Discuss the clinical decision-making process in adaptive trials

12:20 – 12:45 pm: Break

12:45 – 1:30 pm

Time-Saving Triumph: Exploring OC's Dynamic Calendaring Functionality

Join us for an immersive session diving into OC’s dynamic calendaring functionality. This cutting-edge feature empowers researchers and study coordinators to efficiently manage study timelines, appointments, and scheduling with unprecedented ease and flexibility. Learn how to leverage dynamic calendaring to streamline participant visits, optimize resource allocation, and ensure compliance with study protocols. From customizable scheduling templates to real-time updates and notifications, discover how this innovative tool revolutionizes study management and accelerates research progress within OpenClinica’s Core EDC platform.

Learning Objectives

• Understand the fundamentals of dynamic calendaring.

• Learn how to efficiently manage study timelines, appointments, and scheduling using customizable templates and intuitive interface controls.

• Explore strategies for optimizing resource allocation and maximizing study efficiency through dynamic calendaring.

• Discover how real-time updates and notifications enhance communication and ensure compliance with study protocols, ultimately improving research outcomes.

1:35 – 2:20 pm

Better Audits, Faster

Join us for an enlightening session led by our head of compliance. We’ll take you through OC’s quality manual, SOPs and product validation documentation, offering insights on utilizing this open-access content to conduct more thorough audits than in the past.

Though we can’t (and won’t) tell you how to audit OpenClinica, we aim to facilitate deep dives into audit processes and improve overall efficiency through documentation review and discussion.

Learning Objectives

• Learn how to navigate the OpenClinica Quality Management System and validation documentation.

• Learn strategies to leverage open-access content for conducting more comprehensive and effective audits compared to traditional methods.

• Discuss tested methods of streamlining the vendor audit process.

2:25 – 3:10 pm

Unlocking Clinical Data from EHRs with OC Unite & Share

Get ready for an immersive, hands-on session where you’ll delve into the practical application of OpenClinica Unite, coupled with Share for patient-directed data sharing. Step-by-step, we’ll guide you through extracting patient data directly from EHR systems into eCRFs / EDC, eliminating manual errors and speeding up data capture. Discover how Share empowers patients to access and share their own health data securely and effortlessly. Through interactive demonstrations, gain practical experience in synchronizing data in real-time, ensuring accuracy and compliance throughout your studies. By the end of this session, you’ll be equipped with the skills and knowledge to leverage Unite and Share effectively, revolutionizing your clinical research data management, downstream validation processes and patient care.

Learning Objectives

• Discuss the significance of EHR data in advancing clinical research objectives.

• Highlight the types of data available within EHRs and their potential research applications.

• Learn about Share and how to empower patients to access and share their own health data securely.

• Gain insights into data validation, quality assurance, and compliance measures to ensure accurate and compliant data capture.

• Discover best practices for leveraging Unite and Share to optimize clinical research workflows while enhancing patient care.

Tuesday | June 11 | 8:55 am – 3:25 pm | Eastern

8:55 – 9:00 am

Welcome Back & Reminders

Welcome back & reminders or updates. 

9:00 – 9:45 am

Strategic Control: Mastering Randomization & Supply Chain Management

Step into the realm of strategic control with OpenClinica’s advanced randomization & supply chain management capabilities. In this session, we’ll explore how to harness the power of Randomize to optimize your randomization processes and streamline supply chain management in clinical trials. From randomization algorithms to real-time inventory tracking, discover how to efficiently allocate treatment assignments and manage clinical supplies with precision and ease. Join us to unlock the potential of our robust features and revolutionize your trial management approach.

Learning Objectives

• Understand the fundamentals of randomization and supply chain management within the OC platform.

• Learn how to implement randomization algorithms to allocate treatment assignments effectively.

• Explore strategies for real-time inventory tracking and management to ensure adequate clinical supply levels.

• Gain insights into best practices for optimizing trial logistics and enhancing efficiency in trial management workflows.

9:50 – 10:35 am

Tips & Tricks for Rocking Forms

Unlock the secrets to optimizing study efficiency and elevating data quality with advanced calculations and functions in form design. Join us for a deep dive into forms as we explore the intricacies of XPath calculations and logical expressions, presented in a simple and understandable format. Discover how to create electronic eCRFs that not only streamline data collection but also enhance reliability and accuracy. From error checking methods to self-validation mechanisms, learn how to harness the power of complex calculations to process, move, and reuse data effectively. Walk away with practical tips and tricks that will empower you to rock your forms and revolutionize your study processes.

Learning Objectives

• Enhance data quality by implementing form design best practices and study build methodologies.

• Improve data reliability through the strategic use of calculations, logical expressions, and error checking methods.

• Utilize complex calculations to facilitate skip logic and edit checks, optimizing data processing and validation.

• Implement self-validation mechanisms to reduce user burden and ensure data integrity within eCRFs.

10:35 – 10:40 am: Break

10:45 – 11:30 am

Monitoring Mastery: Optimizing Clinical Oversight with OC

Enhance your clinical monitoring capabilities! This session will demonstrate how to construct dynamic dashboards that empower study monitors to efficiently identify and address forms and events requiring verification. Learn to consolidate Insight reports into a single, user-friendly dashboard, and discover the art of creating filters to streamline data analysis. Discover how to configure data review tables which offer real time data within Openclinica and allow users to bulk close queries across multiple participants.

Explore how to seamlessly integrate hyperlinks that allow users to take action from reports and dashboards. Join us to unlock the full potential of OpenClinica and revolutionize your clinical monitoring practices.

Learning Objectives

• Gain proficiency in consolidating multiple Insight reports into a centralized dashboard, simplifying clinical oversight.

• Develop skills in creating custom filters within Insight dashboards to focus on critical data subsets for monitoring purposes.

• Configure data review tables to best suit your study.

• Learn to implement hyperlinks within your dashboard, enabling seamless navigation between Insight and OpenClinica environments for enhanced monitoring efficiency.

11:35 am – 12:20 pm

Empowering Trials: Navigating the Digital Frontier of Informed Consent

In this session, we will explore the pivotal role of technology in revolutionizing the consent process, ensuring efficiency, compliance, and participant understanding. From digital signatures to interactive multimedia elements, discover how electronic consent forms offer a dynamic and intuitive approach to obtaining informed consent. Join us to gain invaluable insights and practical strategies for implementing electronic consent forms effectively, ultimately enhancing the integrity and ethical conduct of clinical trials.

Learning Objectives

• Understand the advantages and challenges of utilizing electronic consent forms in clinical trial settings.

• Explore best practices for designing electronic consent forms that optimize participant comprehension and engagement.

• Learn about regulatory considerations and compliance requirements associated with electronic consent processes, ensuring adherence to ethical standards and data privacy regulations.

12:20 – 12:45 pm: Break

12:45 – 1:30 pm

Customer Presentation: Using OC to Create a Full-Featured Safety Data Management System

A little over 10 years ago, while researching safety data management systems to handle client pharmacovigilance efforts, we determined the best approach was to build one using a technology stack with which we were already familiar. OpenClinica’s flexibility and our familiarity with it made it a perfect fit for our SDMS, especially when we determined that implementing a COTS system would be costly. Within six months of the ‘go’ decision and using only internal resources, we set-up, validated, and deployed a fully functional SDMS using an OpenClinica installation as the primary technology stack.

Not only was it the least expensive choice from an implementation perspective, but our intimate knowledge of the entire system made it the least expensive choice in terms of long-term support. Today, we have migrated the SDMS to the OpenClinica v4 Enterprise technology stack (including Insight) and are working closely with OpenClinica’s team to optimize the build out.
This discussion will delve into the what, whys, and hows of using OpenClinica v4 Enterprise as the core platform for a full-featured safety data management system.

Learning Objectives

• Understand the strategic decision-making process in selecting a technology stack

• Explore the implementation and validation process of an SDMS using OpenClinica

• Evaluate the benefits and challenges of migrating to OpenClinica v4 Enterprise

• Learn about ongoing optimization and collaboration with the OpenClinica team

1:34 – 2:20 pm

Building Successful Studies: A Proven Framework

You’ve just been handed a protocol and asked to build it out in your EDC. How can you make sure that the protocol is implemented in a way that maximizes efficiency and data quality? Getting the details right during the build phase paves the way for a smoother study, generates better data and keeps stakeholders productive and happy throughout the process. This session focuses on understanding a proven framework and best practices for building better studies.

Learning Objectives

• Design with the end goal in mind

• Think critically about data collection workflows to help sites deliver better data, faster

• Right-size your eCRFs for maximum efficacy

• Optimize system functionality: Tips & tricks in OC to help you get your job done easier and faster

2:25 – 3:25 pm

Closing Session: Hidden Gems: Insider Tips from OpenClinica's Head of Product with Extended Q & A

Embark on a journey of discovery as we unveil the hidden features of OpenClinica that you didn’t even know you needed! Join us for an exclusive session curated by our head of product, where we’ll delve into little-known configurations and options that can enhance your OpenClinica experience. From optimizing data display with embedded Insight reports to leveraging background form logic after import, explore the hidden gems that can further streamline your workflows and elevate your trial management game. Don’t miss this opportunity to unlock the full potential of OpenClinica and become a power user!

Bring your queries for the team!

Learning Objectives

• Identify and understand little-known configurations and options to enhance trial management processes.

• Learn how to leverage Visit item data display and participate in embedded Insight reports and content pages to optimize data visualization and analysis.

• Explore techniques for implementing background form logic after import to automate processes and improve data integrity.

• Gain practical insights and tips from our head of product to maximize efficiency and effectiveness in utilizing OpenClinica’s hidden features.

• Provide an open forum to listen to and respond to your queries!

Note: Daily schedule subject to change

Workshops

Wednesday | June 12 | 8:00 am – 1:00 pm (exact timing to be determined by time zones of participants)

Workshop One: Unlocking Insight: Advanced Dashboards & Reporting

 

Join us for an in-depth workshop on OpenClinica Insight, a powerful tool designed to unlock valuable insights from your clinical research data. This immersive workshop will provide participants with hands-on experience and expert guidance on utilizing OpenClinica Insight to its fullest potential. From data visualization to advanced analytics, attendees will gain practical skills and strategies for leveraging Insight to drive impactful research outcomes easier, faster and more reliably than ever. It’s past time to let purpose-built technology do the heavy lifting for you.

Suitable for: This is an advanced workshop. Attendees must have a working knowledge of Insight.

 

Learning Objectives

• Understand the capabilities and functionalities of OpenClinica Insight for data analysis and visualization in clinical research.

• Explore advanced visualization techniques and methodologies supported by built-in tools.

• Develop strategies for effectively building dashboards for yourself as well as stakeholders and decision-makers.

• Learn to navigate and manipulate data across: clinical data, statuses, summary-level study information, SDV, Queries and audit logs

• Gain practical knowledge of SQL: What it is, how to craft SQL queries, and which built-in tools help you achieve success with SQL in Insight.

• Learn to combine data from different tables

• Learn the basics of relational databases and their value to your success with Insight

• Explore advanced Insight capabilities such as embedded reporting on PDP, Participate or third-party apps; segments and metrics; URL generation for linking to OC pages.

 

Don’t miss this opportunity to expand your skills and maximize the value of your clinical research data. Join us for a dynamic led by the builders of Insight and take your research to new heights.

 

Workshop Two: Mastering Form Building Techniques & Advanced Logic Calculations

 

Ready to elevate your proficiency in OpenClinica form-building? Join us for a comprehensive workshop focused on advanced form design and XPath calculations. Whether you’re aiming to enhance study efficiency or elevate data quality, this workshop will equip you with best practices and techniques to optimize your form-building skills. Through a systematic approach, participants will delve into advanced concepts, exploring pivotal elements of study design, cross-form calculations, error checking methods, and effective testing strategies.

Suitable for: Attendees with prior experience in form building, including those who have completed super user training or have equivalent proficiency.

 

Learning Objectives

• Discover form design best practices and study build methodologies to elevate data quality and integrity.

• Implement cross-form calculations and error checking methods to enhance data reliability and accuracy.

• Learn the fundamentals of XPath expressions and how to effectively incorporate them into form design.

• Utilize advanced calculation techniques to process, manipulate, and reuse data for skip logic and edit checks.

• Develop skills in applying filters to XPath expressions to target specific datasets based on user input.

• Gain confidence in tackling form-building challenges through hands-on problem-solving exercises and case studies.

 

Walk away from this workshop equipped with the expertise and tools to tackle complex form-building tasks with precision and efficiency, empowering you to optimize your OpenClinica study designs for maximum impact.

 

Note: Workshops held in parallel with each other. Additional fees apply for workshops. See registration page for details.

 

 

“I found great professional value in all of the sessions – it was useful hearing about the new features and timelines. The ‘Ask us (almost) anything’ was a great session. The team demonstrated extensive knowledge of the product and the passion was very clear.

Feature Speakers

  • Lisa Weiss TDI

    Lisa Torrey Weiss

    Healthcare Technology Consultant, Quantum Leap Healthcare Collaborative

    Lisa Weiss works with healthcare consortiums to innovate care delivery and
    research using technology, data, and collaboration. Recent clients include:
    Quantum Leap Healthcare Collaborative; Population Health Innovation Lab;
    The Dartmouth Institute for Health Policy and Clinical Care.

    Partnering with leading healthcare organizations such as Mayo Clinic,
    Dartmouth Health, and Intermountain Healthcare, Lisa played key leadership
    roles in building organizations from the ground up, including: Founding CEO
    for a consortium of 12 leading healthcare systems sharing data and care
    practices to improve quality and cost of care; founding COO for a start-up
    company that partnered with Deloitte to offer population health software and
    services powered by predictive analytics; and co-founder for a start-up
    company (acquired by Press Ganey) that provided software solutions to
    collect and integrate patient-reported data into clinical practice and research.

    As a management consultant for Arthur D. Little, Lisa led large-scale process
    redesign and technology implementation initiatives for clients in healthcare
    and financial sectors. She has served as an adjunct professor and mentor for
    students at Dartmouth Tuck School of Business and Dartmouth Thayer
    School of Engineering. Lisa earned an MBA from Dartmouth Tuck School of
    Business and a BS in Computer Science from University of Michigan.

  • Dan Milgram

    Dan Milgram

    Sr. Director, Bioinformatics and New Technologies, CCS Associates

    Dan is a systems analyst with expertise in managing full-stack development of novel technologies for the clinical product development life cycle. He has a broad background in clinical, safety/pharmacovigilance and regulatory information systems development and validation. In 2009, he built and implemented the CDMS for a multi-national, multi-government study using OC3 Community integrating clinical and biospecimen data in 3 languages (English, Spanish and Portuguese). In 2015, Mr. Milgram designed and developed a Safety Data Management System (SDMS) using OC3 Community, which is currently in use. In 2022, Mr. Milgram (along with Galen Tran of OpenClinica) co-authored the KA, Creating a Safety Data Management System (SDMS) in your current instance of OpenClinica. Currently, with the assistance of OpenClinica, he is in the process of upgrading the SDMS to leverage new features available on the OC4 Enterprise and Insight platforms. Dan’s session will focus on designing with the end goal in mind as he walks us through how to create a safety data management system within OpenClinica.

  • Rijo

    Rijo Kurien

    Senior Analyst Programmer, Nuffield Dept. of Population Health, Oxford University

    A highly motivated individual with over 4.6 years experience in the health care domain. Experience in various stages of the software development ranging from requirements gathering to system maintenance

  • Sonja Grotjahn

    Sonja Grotjahn

    Senior Analyst Programmer, Nuffield Dept. of Population Health, Oxford University

    An accomplished Senior Software Engineer experienced in a variety of development environments, languages and operating systems as well as software development life cycle tools.

  • openclinica-72

    Cal Collins

    Co-Founder and CEO, OpenClinica

    Cal Collins co-founded OpenClinica with his colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the US Food and Drug Administration (FDA) that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team and the HL7 Vulcan Advisory Council and Steering Committee.

  • openclinica-90-1

    Ben Baumann

    Co-Founder and COO, OpenClinica

    Ben Baumann, is Co-Founder and Chief Operating Officer of OpenClinica, a cloud software provider that accelerates clinical research through automation and smart technologies that enhance data quality. For over 15 years, OpenClinica has helped sponsors, CROs, and academic partners innovate to obtain better data, faster, across 10,000+ clinical studies encompassing all study design types, therapeutic areas, and geographies. In 2022 Ben was part of the team which included the FDA and QuantumLeap Healthcare that won Bio-IT World’s 2022 Innovative Practice Awards for their work integrating EHR and EDC systems.

  • Paul Bowen

    Paul Bowen

    Sr. Director, Product, OpenClinica

    Joined OpenClinica in 2016. Instrumental in building our scalable product team. Highly cross-functional software development expert with over 15 years of eClinical product development experience. Prior roles include senior product owner at Clinical Ink and senior product manager at Outcome Sciences/Quintiles (now IQVIA).

  • Andrea Flathers headshot

    Andrea Flathers

    Vice President, Client Services, OpenClinica

    Joined OpenClinica in August 2020 and is responsible for leading our professional services, customer support and customer success teams. In industry since 2008, she has vast experience in leading implementations and support for eclinical solutions partnering with Sponsors, CROs and AROs. Prior to OpenClinica, she held various positions at Veeva Systems and PhaseForward (now Oracle) within the professional services realm.

  • Chris Weiss headshot

    Chris Weiss

    Vice President, Sales, OpenClinica

    Since 2020, Chris’s deep, hands-on experience with the OpenClinica suite of solutions has made him a key member of our team. He has over 20 years of experience in leadership roles across clinical research and data analytics organizations spanning public companies, startups, consulting firms and academia. Chris earned a bachelor of arts in computer science from Dartmouth College.

  • Laura Keita, Sr. Dir. Compliance, OpenClinica

    Laura Keita

    Sr. Director, Compliance, OpenClinica

    Responsible for leading the OpenClinica compliance program, Laura’s been in the industry since 1980 in various roles including programming, software development, documentation, training, computer system validation and – always – compliance. Having worked at many large pharmaceutical companies as well as a few EDC and RTSM software companies, she always has the customer needs in mind when considering the OpenClinica compliance program and how best to serve our customers.

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OC24: New Roads to Better Data, Faster

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