Countdown to OC17

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“Making the Complex Simple”
9th Annual Global Conference
December 4 – 5 | Sessions and Workshops
December 6 – 8 | Super User Training
Mövenpick Hotel, Amsterdam, Netherlands

Three reasons to attend

Get informed.

Learn from the ultimate authorities: your fellow users. This year’s sessions cover it all.

Get instructed.

Explore our newest release up close. Learn the basics at our workshop, then stay for Super User training.

Get inspired.

Hear from a remarkable keynote speaker, then experience Amsterdam during it’s stunning Light Festival.

Get informed.

Today’s research relies on more sources of data than ever, from tissue samples and genomic sequences to MRIs and ePRO measures. How can automation help us navigate this complexity while ensuring data quality? OC17 will offer some answers in the form of best practices and real-world solutions implemented by our users.

Cal Collins

CEO, OpenClinica

Get instructed.

Last year, the new OpenClinica was a vision. This year it’s reality. Climb “under the hood” of our newest release, featuring an all-new study build module, form engine, and more.

Get inspired.

We’re honored to present Dr. Andrew Bastawrous as our keynote speaker. As an ophthalmologist, humanitarian, and innovator, Dr. Bastawrous has brought clinical diagnosis to patients with blindness in a way that must be seen to be believed. 

Raise a pint and celebrate the season in style. We’ll cap each day with an event to unwind and experience Amsterdam at its most breathtaking. 

Detailed Program

Last updated 31-October-2017

Subject to change.

Monday, December 4, 2017

8:00 to 9:00

Breakfast and Registration

Enjoy a continental breakfast that includes coffee and tea, yogurt, fresh fruit salad, croissants, pastries, cereals and milk. 

9:00 to 9:50 

Plenary Session, “The Story of OC4”
Cal Collins, CEO, OpenClinica
The story of OpenClinica is a story of customer-driven innovation. The latest chapter introduces OC4, a product two years in the making, based on the needs, insights, and collaboration of our community. In this plenary session, you’ll see a solution that:

  • Provides easy, self-service onboarding for all user types
  • Is built around “Smart paper” eCRFs – richly interactive, mobile friendly forms that autosave your data yet give you as much control over layout as if you were designing them in Word
  • Gives you a collaborative, drag-and-drop study build environment with validated design->test->production pathway for your studies and amendments.

We couldn’t deliver these enhancements without changes to OpenClinica under the hood that are just as significant as what you see in the user interface. So what are some of those changes? Find out here.

Cal Collins has served as the CEO of OpenClinica, LLC since its founding in 2003. As an active member of the American Medical Informatics Association and the CDISC e-source Advisory Group, he has joined fellow thought leaders in the drive for better patient, clinician and trial subject experience through the combination of open source, interoperability, data standardization, and related best practices.

Track 1

Track 2

10:00 to 10:50 

OC4’s Ultra-Capable Forms
Ben Baumann, COO, OpenClinica
With OC4, eCRFs are under your control, thanks to a form engine that combines flexibility, capability and visual appeal. Real-time skips, edit checks and calculations , autosave, and progress bars are built right in. “Widgets” allow you to present items such as Likert scales, clickable image maps, visual analog scales, tables, and more. Join this session to see everything OC4 forms have to offer, and how best to leverage these capabilities in your study for a better user experience and better data quality.
Ben Baumann has served as the COO of OpenClinica, LLC since its founding in 2003. He is a veteran teacher and lifelong learner in the eClinical space, having contributed as lecturer, presenter and panelist to forums including the Society for Clinical Data Management (2017), Annual Mobile in Clinical Trials Conference (2016), and Clinical Systems and Technology Marketplace (2015).

10:00 to 10:50 

Essential Reports for the CRC, DM, Monitor, and Sponsor
Bryan Farrow, eClinical Catalyst, OpenClinica
eSource may be gaining traction, but trials today still rely on manual data entry, query resolution, and source document verification. These processes depend on people performing tasks that are  easy to postpone in busy clinical environments. One way of driving better performance is to share metrics that indicate how individuals or teams compare to benchmarks. Learn how to create a data management performance report for each of your study’s stakeholders, and how to deliver it in a supportive way.
Bryan Farrow, OpenClinica’s eClinical Catalyst, has worked in clinical trial operations since 2011, with a focus on improving communication to sites. He believes in approaching the “human factors” of trial operations with clear, compelling messaging that improves performance through data-driven feedback.

11:00 to 11:50 

“Go With the (Work)flow”: Multi-system subject tracking, screening automation, and data exporting
Patrick Murphy, Sr. Director, Data Management, RTI
“Dozens of sites, two patient databases, and complex screening requirements” sounds like a recipe for confusion. But with the right processes and technology in place, site and project staff  never need to worry. Join Super User Patrick Murphy as he presents the multiple challenges posed by a multi-site oncology trial and their solutions:

  • Linking data and subject IDs between OpenClinica and a third party system
  • Embedding edit checks and rules in a Screening eCRF to ensure enrollment of qualified participants only
  • Customizing DataMart to generate charts and reports on enrollment rates, complete forms, and adverse events

 

Patrick Murphy is Senior Director of Data Management at Research Triangle Institute-Health Solutions. He has extensive experience developing and maintaining clinical trial database management environments that are compliant with 21 CFR Part 11 and GCP. Patrick has 22 years’ experience in health-based research data management, plus 10 years of experience as a chemical engineer supporting the development of U.S. EPA regulations.

11:00 to 11:50 

EUPID Services for Pseudonymization and Privacy Preserving Record Linkage in OpenClinica
Markus Falgenhauer, Research Engineer, AIT – Austrian Institute of Technology GmbH
The General Data Protection Regulation allows researchers to link records from difference sources if (a) the patient gives informed consent, (b) the linkage preserves privacy, and (c) the records are for analysis only.  But how can researchers establish this link when different psuedonyms are applied in different contexts (e.g. a biobank, a trial) for the same patient?

The Austrian Institute of Technology GmnH launched EUPID (European Patient Identity Management) to address this challenge in a manner compliant with GDPR. This session will present a use case centered on the Opsoclonus Myoclonus Study (OMS, ClinicalTrials.gov: NCT01868269), currently conducted by a European consortium and requiring record linkage between OMS and different neuroblastoma trials. Learn how the AIT team integrated EUPID in an OpenClinica (OC) instance, linked OC to the EUPID Service, and implemented patient registration via the EUPID Service by batching the OC patient registration form. The system is online and by Sep 15th, 2017 twelve patients have successfully been registered.

 

Markus holds a master degree in electrical engineering with the focus on medical engineering which he received from the Technical University in Graz in 2011. Since 2011 he has been working at the AIT at the research group for digital health information systems. During his work he focused on the development of modules for medical research networks and telehealth platforms.

12:00 to 12:50

Lunch

Recharge with a wrap, sandwich, salad, and beverage.

13:00 to 13:50 

50,000 Participants, 15 Countries, and 1 (Multilingual) OpenClinica Study
Gerben Rienk Visser, Sr. Director, TrialDataSolutions
Simplicity can be hard to achieve, but it’s essential when many of your 500 users, located in 15 different countries, are new to data entry. TrialDataSolutions found success by relying on a “plain-vanilla” setup of OpenClinica. This session will present the implementation of the project, the pitfalls, and the lessons learned.

 

Gerben Rienk has been working in the EDC field for more than 20 years, both as a programmer and as user of software such as Oracle Clinical. He has been actively involved in the OpenClinica community for the last 7 years. As a principal of TrialDataSolutions, he works mainly for academic institutes and non-profit organisations, offering OC trainings, study builds, workflow and API consultation, and more. He loves to share what he finds.

13:00 to 13:50 

MIMS-OC – A Medical Image Management System for OpenClinica
Martin Kropf, Technical Director, Imaging Core Lab Berlin
Advances in web technologies now support direct visualization of imaging datasets without the need to download large file sets or to install software on the local computer. This allows centralization of file storage and facilitates decentral image review and analysis.

This session will present the integration of a medical image management system (MIMS) into OpenClinica; a system that accommodates container formats like DICOM, classical formats like PNG, JPEG, PDF, or movie formats like AVI or MPEG. The MIMS consists of an Alfresco backend as (CMIS) content repository, an HTML5-based image viewer (Cornerstone), and OpenClinica CRFs for image uploading and viewing. An Apache HTTP Server connecting to an OAUTH 2.0 authentication provider based on Windows Azure Active Directory enables SSO to OpenClinica and the Alfresco backend.

 

Martin Kropf is the Technical Director of the Imaging Core Lab Berlin, which runs several clinical trials with imaging endpoints (Echo and MRI). Martin is responsible for project-, process-, data- and quality-management in the lab. Beside the lab, Martin is a senior Java developer (with focus on the Spring framework) and has experience in customizing and integrating OpenClinica in existing IT landscapes. Martin holds a Master of Science in eHealth and is currently finishing his PhD at the Technical University of Graz (Institute of Neural Engineering). His research focuses on ECG analysis and predictive modelling in the context of Atrial Fibrillation.

14:00 to 14:50 

OC4 Infrastructure
Krikor Krumlian, CTO, OpenClinica
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. Climb under the hood with OpenClinica CTO Krikor Krumlian to better understand this model and how it departs from OC3, including:

  • separation of study build and study runtime functions into discrete systems
  • the ability for the study build system to publish a study definition (or updates thereof) to test and production environments to simplify validation / training / UAT / re-use
  • a new model for building forms, based around the powerful and widely used XLSForm standard
  • use of separate database schemas for each study, increasing scalability, portability, performance, and better support of the full study lifecycle
  • a single-sign-on mechanism across the suite of OpenClinica systems and services, with an ability to plug into third-party authentication mechanisms more easily

 

Krikor has over 12 years of experience in software engineering. He was a Principal Software Engineer/Team lead at Constant Contact, a SaaS provider of online marketing services to over half a million customers. Prior to Constant Constant, Krikor served as Architect for OpenClinica and Senior Software Engineer for Axeda Corporation & WGBH Educational Foundation.

14:00 to 14:50 

Late-breaking session
Details forthcoming

15:00 to 15:50 

Risk-adapted Strategies Using OC in an Observational Trial with a Marketed Product
Edgar Smeets, PhD, CCRA, Smeets Independent Consultant – SIC
Smeets Independent Consultant-SIC used OC to collect the data in an observational trial, set up in 2014-2015 in the Netherlands. The trial lasted one year for each participant, with LPLV in September of 2017. In this presentation, Edgar will present the decisions made during set-up and execution of the trial, with an emphasis on the risk-adaptation. Discussion topics include:

  • the risk-based monitoring plan
  • the Investigator Team OC Training Manual
  • communication practices among the management team
  • pros and cons of using OC, with regards to each of the phases

 

Edgar is a Freelance Clinical Research professional, based in the Netherlands. He read Health Sciences at Maastricht University, where he also defended his PhD thesis (Biochemistry; field of thrombosis and hemostasis). Accredited as CCRA by ACRP in 2001, Edgar gained extensive experience in the field of (international) Clinical Research, mainly as a CRA. Research fields include pediatrics/orphan diseases, cardiology, urology, internal medicine, neurology, and oncology. Over the last few years, Edgar has offered his clients risk-adapted and lean eCRF and Data Management services, by using OC community version.

15:00 to 15:50 

Building Biomedical Research Platforms Around OpenClinica: The RadPlanBio Approach
Tomas Skripcak, IT Scientist, German Cancer Consortium (DKTK)
The complex nature of radiotherapy research datasets requires distributed storage and management of data across diverse databases. In this session, you’ll learn how OpenClinica’s transparent data standards and web services made it possible to build and maintain a tightly integrated environment of open source components, each mastering its own data domain.

The presentation will cover:

  • HL7-based patient management
  • physical separation of patient identifiable data
  • implementation of custom randomisation
  • ePRO
  • linkage of medical imaging (DICOM) and treatment planning (DICOM-RT) data
  • biospecimen tracking
  • laboratory data management

Additionally, we’ll discuss the possibility of a dedicated, open source search and analytics engine that leverages the CDISC ODM document structure to drive monitoring, reporting and custom dashboards.

 

Tomas joined the Dresden partner site of the German Cancer Consortium (DKTK) in 2013 as a postdoctoral fellow with the goal of establishing radiotherapy-specific clinical research IT infrastructure. He is the main developer of Dresden RadPlanBio platform that promotes vendor neutral data standards, open source software components, and web-services-based system integration as the basis for a long-lasting translational research IT environment. His responsibilities include the administration of OpenClinca-based systems within RadPlanBio and the development of new platform components.

16:00 to 16:50 

Turning Study Risks into Successes with Risk-Based Monitoring
Artem Andrianov, PhD, CEO, Cyntegrity
A recent analysis on the efficiency of the average clinical trial, conducted by the Tufts Center for the Study of Drug Development, indicated several areas for drastic improvement. The average trial undergoes 2.2 amendments with a median cost of $535,000 each for a phase III protocol. 38% of changes made as a result of substantial protocol amendments are related to safety assessment activity.

 

We believe that these costs and risks are avoidable. Thus, obviously, an average clinical trial can escape from $1,177,000 of unneeded costs. We set up a process and technology to foster planning and risk management of a trial. The cloud-based tool with an RBM process was validated in several clinical trials.  

1. Start with risk identification and risk assessment.
2. RACT (Risk Assessment Categorization Tool) consists of a set of categories and questions; we connected them to risks and assign mitigation actions to risks, not to questions.
3. The next step is a compilation of risk register, risk management plan, and RBM plan. Here the technology helps. Apply the cloud-RACT for more efficient collaboration.
4. The identified risks are connected with mitigation actions and data-driven key risk-indicators (KRIs) and key performance indicators (KPIs), which source information from a holistic range of recording systems (EDC, CTMS, etc.).
5. The data-driven KRIs and KPIs are connected to issue management system coped with a CAPA process.
6. Based on risk-profiles of sites the monitoring is adaptively adjusted and SDV reduced. Monitoring efficiency indicators guide us in this process.
7. During this integration of risk-based monitoring and quality management, we work tightly with monitoring and study team.

In result, the studies have received a new process from the risk management. The comparative analysis demonstrated the potential of efficiency, time and costs optimization. The set of cloud-based tools are ready to be used with OpenClinica.

 

Artem Andrianov, PhD, serves as CEO for Cyntegrity. He has more than 15 years of experience in data quality projects, risk-based monitoring, and biostatistics for the pharmaceutical industry, with expertise in an array of indications and modalities that include spirometry, ECG, oncology, ePRO, and clinical data management. Artem’s life passion is to make clinical trials safer and more efficient by improving clinical research with Risk-based Monitoring (RBM) and pushing RBM to new frontiers. He graduated with degrees in software engineering, a Bachelor of Economics, and a Master of Business Administration.

16:00 to 16:50 

New approaches to CDISC SDTM Submission Automation Mark Wheeldon, CEO, Formedix 
In December 2016, the FDA passed regulation requiring that new drug submissions contain clinical trial datasets that conform to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation (SDTM) standards. However, CDISC standards are not just about regulation. They can save time and money in the set-up, conduct, and submission of clinical trial data.  This session will compare and contrast a traditional SDTM dataset conversion process performed by 2 teams of SAS programmers versus a CDISC metadata driven approach which uses CDISC Define.xml in novel ways to:

  1. automate source, target and mapping specification creation,
  2. give dataset conversion engines study specific transformation instructions, and
  3. eliminate manual coding.

We will show how this CDISC metadata driven approach with Define.xml has lowered CDISC SDTM conversion times by 70%.  The final part of our presentation will look at additional SDTM conversion scaling strategies that can be implemented in order to (a) reduce mapping effort on a study-by-study basis and (b) support multiple SDTM versions.

 

In 2000, Mark, a Pharmacist, founded Formedix, a leading supplier of clinical trial automation software and services based on standards developed by Clinical Data Interchange Standards Consortium (CDISC). He has proven that by using Formedix software coupled with the end-to-end use of clinical data standards from form design through to submissions, that 70% of the time and cost of both study set-up and dataset conversions can be achieved. Today, Mark remains passionate about helping companies adopt CDISC standards as early as possible to capitalize on new opportunities to optimize clinical trial processes.

18:00 to 21:00

“Drinks and Demos at Delirium”

Hoist a pint, grab a bite, and talk shop (or not) with fellow community members. Meet OpenClinica’s “extended family” from Bio-Optronics, Vigyanix, Cyntegrity, Formedix, and OpenSpecimen, and enjoy informal demos of the powerful technology available to broaden the impact of your OC instance.

Location: Delirium Cafe Amsterdam, Piet Heinkade 4-6-8, 1019 BR Amsterdam. The cafe is just a three-minute walk from the Movenpick Hotel.

Tuesday, December 5, 2017

8:00 to 9:00

Breakfast and Trivia

Enjoy a continental breakfast that includes coffee and tea, yogurt, fresh fruit salad, croissants, pastries, cereals and milk. While fueling your body, warm up your grey matter for another day of learning with live-action trivia.

9:00 to 9:50 

Keynote Session, “Peek Vision – Using Mobile Technology and Human-Centred Design to Radically Increase Access to Life- Changing Eye Care”
Dr. Andrew Bastawrous, Co-Founder & CEO, Peek Vision
“When we first moved to Kenya, we went with 150,000 dollars of equipment, a team of 15 people, and that was what was needed to deliver health care. Now, all that’s needed is a single person on a bike with a smartphone. And it costs just 500 dollars.”

Great innovation is born from great challenge. Learn how Dr. Bastawrous and his team are helping hundreds of thousands of people in the poorest regions of Africa who are living with blindness caused by a treatable condition. Dr. Bastawrous will speak to the validation of his diagnostic instruments, all available on mobile Android devices. Just as importantly, he’ll remind us that simplicity, while not always easy to acheive, often wields immense healing power.

Dr. Andrew Bastawrous is Co-Founder & CEO of Peek Vision, a social impact organization working to radically increase access eye care in some of the most challenging places in the world. Andrew is an Ophthalmologist (Eye Surgeon), and an Assistant Professor in International Eye Health based at the International Centre for Eye Health, London School of Hygiene & Tropical Medicine where he teaches on public health for eye health and leads a research portfolio.

Track 1

Track 2

10:00 to 10:25

Health-RI, the Dutch national research infrastructure initiative to bridge the valley of death in personalised medicine research Jan Willem Boiten, PhD, Program Manager, Lygature
Health-RI is the Dutch national research infrastructure for personalised medicine & health, initiated by the joint efforts of several existing research infrastructures such as BBMRI, EATRIS and ELIXIR, as well as the collaborating Dutch university medical centers. Health-RI aims to enable excellent personalized medicine & health research by facilitating the research process from start to end. To this end Health-RI acts as a public utility with a portfolio of services including catalogues of data, images and samples, ELSI services, a digital research environment and software tools, and a connected data backbone for FAIR data stewardship.
As a not-for-profit organization, Lygature aims to accelerate the development of new medical solutions for patients by driving public-private collaboration between academia, industry and society. As one of Lygature's leaders, Jan-Willem works at the intersection of IT and health research. He has more than 20 years’ experience with multi-center collaborations across the life sciences.

10:25 to 10:50

 Overcoming the challenges of patient reported outcomes using OC considering multilinguistic users
Vishal Kapoor, Program Data Manager, Terumo

Quality of life is a critical measure in many oncology trials, and patient reported outcomes typically offer the richest and most true-to-life data in this regard. But how do you ensure comprehensive and timely entry from participants?

Terumo adapted OpenClinica's ePRO module, Participate, to collect the quality of life questionnaire at different time intervals in one of their oncology trials. To ensure universal useability and convenience while maximizing data quality, Terumo:

  • collected requirement specifications
  • designed multilingual X-forms
  • developed automated, XML-enabled rules to notify and remind subjects
  • tested the completed module in various mobile and other electronic devices

The results:

  • More accurate and timely responses promoting a higher level of Subject compliance
  • reduction in site coordinator’s time to question patients
  • reduction in time spent on administration
  • elimination of bias from witnessed reporting
  • reduction in study cost as data is directly transferred to the database with no real need of discrepancy management

Vishal has over 11 years of experience in providing end-to-end clinical data management solutions. He has led the data management group within Terumo Europe since 2013. Previously he had worked with MSD (Merck & Co.) and HCL Technologies. He has worked in different therapeutic areas across the medical device and pharmaceutical industry. He graduated with an Engineering degree in Bioinformatics and also holds a Master degree in Management Science.

10:00 to 10:50 

Combining a Nationwide Prospective Registry With Multiple RCTs in a Single OpenClinica Dataset
Nora Hallensleben, Medical Doctor, and Remie Bolte, Software Engineer, Dutch Pancreatitis Study Group (DPSG)
In 2011, the Dutch Pancreatitis Study Group (DPSG) launched an ambitious project to create a centralized database of patient data regarding acute pancreatitis patients. The project goal was to create a single dataset containing a nationwide prospective patient registry as well as current, and future randomized controlled trials. After an unsuccessful attempt using Oracle Clinical, the DPSG switched to OpenClinica, hoping it would be able to facilitate the study group goals.

The nationwide registry consists of patient variables of more than 3000 subjects, including (re-)admission, lab results, and classification of disease severity. The data can span several years due to multiple episodes of recurrent pancreatitis and long-term complications. In addition, it contains study specific data for all current and future DPSG randomized control trials. Having all this data together in one single Electronic Data Capture system gives the DPSG unique research opportunities for a better understanding of acute pancreatitis. The presentation will discuss the challenges involved in creating such a unique nationwide patient registry.

Remie Bolte will join the stage as co-presenter to showcase the technical enhancements to OpenClinica to enable the DPSG to achieve its goals and improve productivity of the DPSG researchers. Unorthodox use of OpenClinica features allowed the DPSG to automate complex calculations, like classification of disease severity, by using the OpenClinica API to combine data from multiple CRFs.

Nora Hallensleben is a medical doctor, currently working as a PhD student with the Dutch Pancreatitis Study Group (DPSG). She coordinates a multi-center randomised controlled trial on early interventions in acute gallstone pancreatitis. Furthermore she coordinates the PWN-CORE, a nationwide registry for acute pancreatitis patients.

Remie Bolte is a software engineer who has helped the Dutch Pancreatitis Study Group (DPSG) getting the most out of OpenClinica. He has created a set of enhancements that have improved the overal user experience, including automatic calculations of predictive scores which dramatically increased productivity of DPSG researchers. During the presentation, he will demonstrate some of the techniques that were used to achieve this.

11:00 to 11:50 

E-Consent: A New Application of OpenClinica ParticipateTM
Brittany Stark, Project Manager, OpenClinica
Informed consent is more than a regulatory requirement: it’s the start of a relationship with a trial participant. Clarity and comfort are essential to the process of arriving at informed consent. With eConsent, Investigators and their team can now offer convenience as well. Learn how to adapt ePRO-style forms, at the heart of OpenClinica Participate, to incorporate eConsent with e-signature into your trial.
Brittany directs client projects involving the implementation of clinical trials using OpenClinica software. She oversees the planning, build, testing, and delivery of client projects on time, within scope and in budget.
Prior to joining OpenClinica, Brittany 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, she gained experience as a Clinical Research Coordinator, Regulatory Affairs Specialist and later Clinical Trials Staff Educator.

11:00 to 11:50 

Open Conversation: A Dialogue Between OpenClinica and OpenSpecimen Srikanth Adiga, CEO, OpenSpecimen, and Aurélien Macé, Data Manager, FIND Diagnostics
OpenSpecimen is an open source biobanking informatics platform to track and annotate biospecimens. API integration with OpenClinica puts this tracking in the context of your EDC for turn-key data and biospecimen management.  Learn how OpenSpecimen and OpenClinica worked in concert to support research at FIND Diagnostics.
Srikanth “Sri” Adiga is the founder and CEO of Krishagni, the company the built and maintains OpenSpecimen. Sri interacts closely with clients and the development team in addition to leading business operations. He is an open source evangelist who is eager to help others use open source technologies to run their business.

12:00 to 12:50

Lunch

Recharge with a wrap, sandwich, salad, and beverage.

13:00 to 14:50 

WORKSHOP
Designing Your Study in the New OpenClinica
Laura Keita, Director of Compliance and Training, OpenClinica
The Study Build System is a cornerstone of the new OpenClinica, bringing the design of your study to life through an intuitive, “drap-and-drop” interface. Learn how to quickly associate forms with events, collaborate with fellow trial managers, publish your studies to test and production environments, and track changes to your design through this powerful module.
Laura Keita has worked in biotechnology and pharmaceutical research for more than 30 years, over a decade of which was spent as an auditor of e-clinical system providers. Her varied background includes roles in SAS programming, software development & validation, documentation, and training. Laura developed and delivered training programs for Clintrial, Clintrace, Oracle Clinical, Empirica Study, and Empirica Signal.

13:00 to 14:50 

WORKSHOP
Reporting and Data Visualization with OC Insight
Lindsay Stevens, Solutions Engineer, OpenClinica
Data managers need quantitative snapshots of their
study data–ones that can be understood at a moment’s glance. Without them, reporting on enrollment
progress, planning for locks, tracking adverse events,
managing SDV, and holding sites accountable to
form completion and query resolution deadlines all become
impossible. 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.

Lindsay is clinical trials data management (CTDM) specialist with 9 years’ experience spanning the trial data lifecycle. A long-standing power user in our commmunity, Lindsay officially joined OpenClinica in 2017, bringing with him a set of strong technical skills in applications programming, analytics and visualisation tools, IT system administration, and security standards.  He holds a Bachelor of Science from Macquarie University and is now pursuing a Master degree in biostatistics.

15:00 to 16:50 

WORKSHOP
The World of OpenClinica APIs
Krikor Krumlian, CTO, OpenClinica
OpenClinica is constantly expanding 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.
Krikor has over 12 years of experience in software engineering. He was a Principal Software Engineer/Team lead at Constant Contact, a SaaS provider of online marketing services to over half a million customers. Prior to Constant Constant, Krikor served as Architect for OpenClinica and Senior Software Engineer for Axeda Corporation & WGBH Educational Foundation.

15:00 to 16:50 

WORKSHOP
Achieving More Through OpenClinica Partnerships
Michael Sullivan, Senior Directors of Sales, OpenClinica
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, and ask questions of, the passionate technologists behind these partnerships, including:

  •  Bio-optronics (clinical trial management)
  • Vigyanix (healthcare applications, HIPAA compliance, and Enterprise mobility)
  • OpenSpecimen (biospecimen collection, shipping, and tracking)
  • Cyntegrity (risk-based monitoring)
  • Formedix (SDTM)

In just one two-hour workshop, get up to speed with all you can accomplish with OpenClinica’s “extended family.”

Michael is a technically-oriented new business professional dedicated to finding the right fit between study needs and OpenClinica resources. Prior to joining the team at OpenClinica, Michael helped clinical research clients tap the power of a proprietary cloud-based data networking and collaboration platform as a member of Lincoln Peak Partners. While at Lincoln Peak, he was part of the leadership team that transitioned the company from an IT services & consulting business to a product-focused Software-as-a-Service business providing distributed data solutions to the clinical research market.

17:40 to 19:00

Water Colors Cruise

Immediately following the last workshops of the day, we’ll head into Amsterdam Centre, where we’ll board a heated/covered boat to take in the brilliance of the city’s Light Festival.

Location: Prins Hendrikkade 25. 1.4 km from the Movenpick Hotel. We’ll check in at 17:20.

Venue

Pricing

Sessions and Workshops (December 4th and 5th)
Discount available to presenters and groups. Inquire here.

Super User Training (December 6th, 7th, and 8th)

$2000 per student for OC3 course
$1500 per student for OC4 course
Delivered on site, with lunch served daily.
Details on OC3 training available here. (Register via the form below). OC4 curriculum details forthcoming.

Accommodations

Attendees are responsible for booking and paying for their own accommodations. Rooms are in high demand in Amsterdam during December. We recommend booking today to secure the best location and rate possible. Click here for a real-time listing of rates.

Reserve your room at the Mövenpick Hotel Amsterdam City Centre website or refer to their list of contact phone numbers.

Other nearby hotels:

Pension Homeland Amsterdam
Gebouw 006, Kattenburgerstraat 5, 1018 Amsterdam, Netherlands
http://www.pensionhomeland.com/en/
+31 20 723 2550
(1 km away)

NH Collection Barbizon Palace
Prins Hendrikkade, 59-72. 1012AD, Amsterdam, Nederland
https://www.nh-collection.com/nl/hotel/nh-collection-amsterdam-barbizon-palace
+1 646 760 2413
(1.1 km away)

Lloyd Hotel & Cultural Embassy
Oostelijke Handelskade 34, 1019 BN Amsterdam, Netherlands
http://www.lloydhotel.com/
+31 20 561 3636
(1.5 km away)

Registration

Each attendee’s registration includes two days of workshops and sessions. You are free to move between the learning tracks at will. Breakfast and lunch will be served both days. A gala event will be held the evening of December 4th. Your registration fee includes admission to this event.