Opening Doors to Data

Main Conference: 15 - 16 May
Workshops: 17 May
Training: 17-18 May

Join us at OC23!
Register early for special pricing

This year it’s all about opening doors to data so you can get your job done easier, faster and better than ever. We’ll spend our time together creating studies, building and optimizing forms, and getting comfortable with all the new features, enhancements and functionality you’ve come to expect from us.

In addition to our expert training professionals, we’re featuring special sessions created by customers. The main conference offers two programming tracks to expand your choices and best match educational experiences with your interests.

Join us for two, three or five days packed with hands-on learning.


Main conference, workshops and training available separately or together.

Main Conference (15 - 16 May)Workshops (17 May)Super User Training (17 - 19 May)

Main User Group Conference

Monday, 15 May, 11:30 am – 4:30 pm

11:30 – 12:30: Welcome Lunch

12:30 – 1:30

Track A: New Feature Round Up!

Features & functionality to make your job easier. Highlights include:

• eConsent: Create engaging digital consent experiences for remote and in-person participants
• Auto-generate annotated eCRFs: Makes it easier to understand study configurations
• Automated & Centralized Calendar: Simplified approach to updating and maintaining protocol calendars to meet shifting needs
•Streamlined navigation between key pages provide time-saving shortcuts

Track B: So Long, SDV!

Dive into the only EHR to EDC solution capable of auto-populating your eCRFs on study day one. Practical, scalable functionality that’s proven to lessen the burden for researchers, sponsors and patients alike. Learn how to:

• Get finalized, verified data on study day one
• Ease the burden for CRCs with automation
• Simplify enrollment, data sharing and participation for patients
• Enhance decision support for site and sponsor stakeholders
• Say so long to SDV!

1:30 – 2:30

Track A: Building Data Pipelines: Different Modes of Data Capture.

From paper to eSource, understand all the ways OC can support and streamline your data capture.

Track B: Health Data Interoperability with HL7 FHIR and Vulcan in UK and Europe

The Vulcan Accelerator aims to bridge data transfer gaps between Clinical Care and Clinical Research. This session will describe how Vulcan operates, its successes to date and future plans, with a focus on the impact across the UK and Europe.

2:30 – 3:30

Track A: Customer Case Study: Getting to SDTM: Designing for the End Goal.

Track B: Customer Case Study: Migrating Data Mid-Study - Lessons Learned from Migrating 12 Studies in 12 Months.

Migrating data mid-study is no small feat. But getting data out of a legacy system and into OC’s EDC is more than worth it. Join this session to get the good, the bad and the ugly. We’ll discuss:

• Background – Why migrate?
• Process
• Timings
• Challenges
• Lessons learned

3:30 – 4:30

Track A: Partner Presentation: Randomization and Supply Management.

Track B: Ditch the Spreadsheet! The Power of Insight to Ease your Workflow.

Insight is like a toolbox. This session will highlight some of the key tools Insight provides – including some you might not know about –  and how to use them to manage your studies more efficiently. You will learn:

• What reports come built-in with every study
• How to build custom reports and the easiest ways to reuse them across studies
• Where to find everything you might want to know about your Insight database
• How to use Insight to build tools for adjudication, RBM, and AE alerts
• What possibilities exist for embedding Insight dashboards for site/study personnel or patients to access
• The best ways to extract your data from Insight

5:00 – 8:00: Included in registration: Dinner & drinks at Coco Momo Kensington!

Tuesday, 16 May, 8:00 am – 4:00 pm

8:00 – 9:00: Breakfast

9:00 – 10:00: Keynote: Opening Doors to Data

10:00 – 11:00

Track A: Introducing eConsent: Beyond the Signature.

eConsent goes beyond the digitally-compliant signature to give you an easy way to create and share engaging digital experiences for remote and in-person participants.This session will show you the different ways the OpenClinica eConsent module can guide your participants through the informed consent process by demonstrating how to build an effective consent form and what the experience could be like from a participant’s point of view in an in-person or remote setting.Learning Objectives:

• How to build an eConsent form that is an interactive experience for the participant rather than a document they have to read
• What it’s like for a participant to consent using OpenClinica
• What tools the OpenClinica eConsent module provides for tracking consent

Track B: Image Adjudication

This presentation will demonstrate how you can utilize OpenClinica’s flexibility with the EDC where you can use the form designer to create a unique workflow for Image Adjudication. The model has image reference, slide verification, and in-form timers to capture various metrics of the adjudication process. Pathologists can view these forms and not interfere with one another, while recording their findings. The model also demonstrates data imports and read-only fields that will be useful to the pathologist during their image reads.

• How to link external hyperlinks to image references
• How to rethink use cases for OC4
• How to create start and stop timers for testing reaction time
• How to use import and calculations to display information for data export

11:00 am – 12:00

Track A: Your Digital Front Door: Improve Participant & Clinician Satisfaction.

Attracting & retaining trial participants is getting harder. CRCs are burnt out. Learn how to leverage OC to help increase engagement & satisfaction for participants and clinicians alike.

This presentation will demonstrate how you can utilize OpenClinica Participate to design forms for participant data entry. These electronic Patient Reported Outcomes (ePRO) forms are fully integrated in the study. Participants can enter data at scheduled time, and the data is immediately available for review by site and Study-level users. Participant can access these forms on their own devices (smart phone, tablet, laptop, or desktop computer) and submit them back to the study. Learning Objectives:

• How to activate Participate
• How to control which forms are available for each participant
• How to invite participants
• How to design Participant forms for efficient data entry

Track B: Clinical Monitoring with OpenClinica.

This presentation will demonstrate how you can build a dashboard using both the simple report builder and SQL in Insight. This will allow your study monitors to identify only the forms and events that require verification.  With a simple click on the dashboard, you will be directed to the participant details page, a filtered SDV table, or a filtered queries table on OpenClinica. Learning Objectives:

• How to consolidate all your insight reports  into a single dashboard
• How to create filters in a dashboard
• How to hyperlink from your dashboard into your OpenClinica environment

12:00 – 1:00: Lunch

1:00 – 2:00

Track A: Sneak Peek: Releases & Roadmaps.

Plan ahead! Get the low-down on upcoming releases and roadmaps.

Track B: Calculations and Functions in Forms: Get Smarter about Study Efficiency and Data Quality.

In this presentation you will learn calculations, functions and logical expressions in a simple and understandable format. Creating eCRFs and using XPath calculations to optimize your study efficiency and data quality has never been easier. You’ll walk away knowing:

• How to improve data quality with form design best practices and study build methodologies.
• How to improve data reliability with calculations, logical expressions, and error checking methods
• How to use complex calculations to process, move, and reuse data for skip logic and edit checks
• Learn how to have your forms self-validate and take burden off your users

2:00 – 3:00

Track A: Customer Case Study: Alternative Ways to Use OC: Safety Data Management Systems.

We love innovative thinking! Learn how one customer uses OC as a safety data management system (SDMS).

Track B: Special Customer Presentation: TBD.

Check back for details.

3:00 – 4:00

Farewell Tea: Ask Us (almost) Anything!

An open forum to ask questions around issues specific to you. Questions submitted in advance to help our team prepare. Bring it!

Note: Registration includes breakfast, lunch, tea and Monday’s dinner.


Wednesday, 17 May, 8:00 am – 3:30 pm

Workshop One: The Art of the Possible: Insight Dashboards & Reporting

In this full-day workshop you will dive into the best-kept secrets of OpenClinica Insight. You’ll learn how to take full advantage of built-in reporting and dashboard creation to get your job done easier, faster and more accurately than ever before. It’s past time to ditch spreadsheet reporting and let purpose-built technology do the heavy lifting for you.

Suitable for: All skill levels

Learning objectives: You’ll walk away knowing:

    • What data are in Insight and how they are organized
    • Where to find key data reports across: clinical data, statuses, summary-level study information, SDV, Queries and audit logs
    • How to build and use both basic and advanced visualizations using built-in tools
    • How to build dashboards for yourself and external stakeholders
    • What the basics of relational databases are and their value to Insight success
    • How to combine data from different tables
    • What SQL is, how to craft SQL queries, and which built-in tools help you work with SQL in Insight

We’ll also 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.

Workshop Two: Advanced Form Building & Logic Calculations

Are you ready to take your OpenClinica form-building skills to the next level? This full-day workshop will cover best practices for creating eCRFs and advanced XPath calculations to help you optimize your study efficiency and data quality. In a step-by-step process, you will add new techniques and skills across key form concepts. We’ll explore guiding principles of study design; design roles and responsibilities, how to create libraries, manage timelines, develop time-saving cross-form calculations, and how to test your study design process before implementation.

Suitable for: Users who have either attended super user training or have some form building experience.

Learning objective: You’ll walk away knowing:

    • How to improve data quality with form design best practices and study build methodologies
    • How to improve data reliability through cross form calculations and error checking methods
    • How to use complex calculations to process, move, and reuse data for skip logic and edit checks
    • When and how to use XPath expressions
    • How to add filters to your expressions to target specific datasets based on user entered data

We’ll also focus on developing the problem-solving skills you need to walk through any form-building challenge.

Workshop schedule (both workshops):

8:00 – 9:00 – Breakfast

9:00 – 12:00 – Workshop, part one

12:00 – 1:00 – Lunch

1:00 – 3:30 – Workshop, part two


Note: Workshops held in parallel with each other and the first day of SUT. Additional fees apply for workshops and super user training, See registration page for details. Registration includes breakfast, lunch and tea.

Super User Training (SUT)

Wednesday – Friday, 17 – 19 May

Our most comprehensive course that prepares data managers and study designers to productively work with OpenClinica. This highly interactive, in-depth training is designed and taught by the same professionals who design, build and test the OpenClinica software.

Learning objective: Become a confident and effective study builder; enhance existing skill; optimize settings and workflows; learn often overlooked functionality; troubleshooting; tips and tricks.

Suitable for: All skill levels

Note: The first day of SUT is held in parallel with workshops. Check workshop tab for details.

Wednesday 17 May

8:00 – 9:00 – Breakfast

9:00 – 12:00 – System demo; introduction to workspaces; form building basics

12:00 – 1:00 – Lunch

1:00 – 3:30 – Publishing to test; testing form logic; review and revise; leveraging OC resources and support

Thursday 18 May

8:00 – 9:00 – Breakfast

9:00 – 12:00 – Publishing to production; sharing the study internally and externally

12:00 – 1:00 – Lunch

1:00 – 3:30 – Advanced form features (e.g. calculations, cross-form logic, external lists)

Friday 19 May

8:00 – 9:00 – Breakfast

9:00 – 12:00 – Data imports; data extracts; reporting, dashboards and data visualization

12:00 – 1:00 – Lunch

1:00 – 3:30 – Managing ePRO and randomization modules; notification actions; scheduling rules


Note: Additional fees apply for workshops and super user training. See registration page for details. Registration includes breakfast, lunch and tea.

Featured Speakers

  • Amanda

    Amanda Bravery

    Head of ICT, at Imperial Clinical Trials Unit, Imperial College

    Amanda is a highly skilled manager and leader with over 25 years industry experience from working in a large Contract Research Organisation, Pharmaceutical company, and the last 12 years in an academic Clinical Trials Unit.

    Included in her successes, is the introduction of new systems into Imperial College for electronic Clinical Data Capture and undertaking systems migration working with stakeholders nationally and globally, with consideration for Business Continuity, Information governance, IT Security, Audit and Quality management. Amanda is Chair of the UKCRC Data and Information Systems Operational Group (DaISOG) and a member of the ACDM Data Management Expert Group.

    Amanda and her team recently migrated more than 12 ongoing studies from a legacy system to OpenClinica. More impressively, they accomplished this feat in around 12 months without study interruption. Amanda will speak candidly about her and her team’s experience. It’s a session not to be missed.

  • tonyb

    Tony Brady

    Founder, Sealed Envelope

    Tony Brady is a qualified medical statistician who founded Sealed Envelope in 2001 to offer an online randomisation service for clinical trials. Previously Tony had worked at the MRC Clinical Trials Unit and Imperial College London UK as a research statistician, and provided independent statistical support to the data and safety monitoring committees for both industry and publicly funded clinical trials.

    Tony’s presentation focuses on best practices for high-quality randomization and supply management.

  • Dan Milgram

    Dan Milgram

    Senior 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 and how to design

  • Ed

    Ed Chappell

    Consultancy Team Lead, Formedix

    Ed Chappell has been working as a Solutions Consultant with Formedix for over 13 years. He authored and presents our training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. Ed was heavily involved in the development of our ryze dataset mapper, and works closely with customers on SDTM dataset mapping. As an expert in clinical data programming, Ed also supports customers with Interim Analysis (IA) SDTM and FDA SDTM clinical trial submissions.

  • openclinica-72

    Cal Collins

    Co-Founder & CEO, OpenClinica

    Cal co-founded OpenClinica with 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.

    Cal will deliver this year’s keynote: Opening Doors to Data

  • openclinica-90-1

    Ben Baumann

    Co-founder & COO, OpenClinica

    Ben co-founded OpenClinica with colleague Cal Collins in 2006 to make it easier for study teams to carry out high-quality clinical research using modern technology. As OpenClinica’s chief operating officer, Ben has helped develop the company into a leading provider of cloud-based solutions to automate and accelerate clinical trials and deliver a superior end-user and patient experience. His passions include finding human-centric ways to unlock existing sources of real-world data for clinical research. Ben earned a bachelor’s degree with honors from Harvard University.

    Ben’s session on different modes of data capture to build data pipelines is especially relevant as more and more sources of medical data are making their way into clinical research.



Conference Location

58 Prince’s Gate, London SW7 1QQ

Owned and run by Imperial College London, 58 Prince’s Gate forms part of the Freake Estate, designed by Charles James Freake in the 19th century. Located in the heart of South Kensington, this impressive house boasts Edwardian features, original chandeliers and historic paintings. 58 Prince’s Gate is easily accessible by public transportation and close to downtown and major attractions.


Monday Evening Dinner & Drinks

Coco Momo Kensington
25 Gloucester Rd, South Kensington

Coco Momo Kensington is a bright and airy café, bar and British brasserie in one of London’s most sought after areas.



South Kensington is home to many lovely accomodations within walking distance of the conference venue.

We have arranged a discounted rate for conference attendees at The Bailey’s Hotel London Kensington.





Discount: 10% off online rates and reduced breakfast from £22.50 to £15 per person
Use code: Openclinica
Travel dates: 14.15.2023 to 20.05.2023
Guests need to provide credit card to guarantee the booking.
Online payment link will be sent once booking confirmed.
Cancellation policy is 30 days before date of arrival.
Call 44 2073 736000 or email


Note: Lodging and transportation are not included in registration.


Conference address: 58 Prince’s Gate, London SW7 1QQ

Monday’s dinner: Coco Momo, 25 Gloucester Rd, South Kensington, SW7 4PL



OC23: Opening Doors to Data

Sign up today for two, three or five days of hands-on learning!

15  – 19 May

London, England


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