Monday, September 30

12:45 PM – 01:30 PM
Shortening Database Builds by 40-60% with Agile Design

Radical time savings aren’t possible with incremental process improvements. However, inefficient build processes are often the byproduct of EDC limitations. An agile EDC enables process transformation that shortens database builds by 40-60%. Veeva describes the technologies and processes behind those savings, including spec-less design, real-time UAT, and easy amendments.

Speakers: Richard Young, vice president, Vault CDMS
Sharmin Nasrullah, solution consultant, Vault CDMS

EDC, ePRO, eConsent, eZ:
How a Unified Approach to Data Collection Makes Everything Easy

So you want to include ePRO and eConsent into your trials but are concerned about adding two more vendors with the associated cost and complexity?  See how OmniComm’s EDC solution can overcome this with a single EDC/eConsent/ePRO capability.

Driving Real-Time and Quality Insights Through Direct-from-Patient eCOA Data Collection to Accelerate Study Timelines and Enhance the Patient Experience.

Traditional paper-based patient data collection makes real-time insight very difficult or impossible to gather and understand. There’s a clear need for a more effective and efficient solution.

In this session, we will discuss the evolution of electronic clinical outcome assessments (eCOA), highlight how new technologies can strengthen patient data collection, and share insights into rapid implementation of eCOA in a study.

We will share a brief demo of IQVIA’s new eCOA technology platform and how using state-of-the-art technology can flip the development lifecycle upside down and shorten eCOA implementation timelines.

Speakers: Arshad Mohammed, Senior Director, eCOA, IQVIA

Monday, September 30

03:15 PM – 04:00 PM
Participant-Centric Data Collection

During this session you will learn how Medrio can enable your trials to move toward patient-centric data collection. Our eClinical tools empower Data Managers with the combination of data collected from both patients and trial site staff, as well as labs and other sources. The combination of Medrio EDC, DDC, ePRO, and eConsent gives you the solutions needed to move from traditional EDC to gathering data directly from study participants.

Speakers: Gabriel Westerlund, Sales Engineer, Medrio
Tony Brown, Senior Product Manager, Medrio

Visualize Site and CRO Performance and Take Control of Your Clinical Study

Clinical trial sponsors are rightfully concerned about losing control of their study and their study data when they outsource. No wonder, since many studies can involve a dozen vendors or more. Getting the right information to track performance and efficiency within a useful time frame can be ‘challenging’.
In this demonstration, see ways that CONFERO data visualization and reporting will help you take back control of your studies. Quartesian experts will demonstrate ways to better track site and CRO performance and show how data visualizations help you more easily see the status of your study and patient enrollment — along with your site and CRO performance. Electronic Data Capture and site metric data provide a wealth of data that can provide an accurate status for each study. With easy-to-understand reports and visuals we can transform this data into real-time information to make better informed decisions. Working with a partner who doesn’t have a direct stake in the outcome of the reports can be key to taking control of your clinical data.

Advantages of a Unified EDC/CDMS for Study Designers

IBM Clinical Development is a truly unified EDC system where creating a new study environment is easy and doesn’t require IT, research and development, and any other barriers that typically hinder speed and efficiency. With IBM, you have access to all of our EDC and eClinical functionality such as ePRO, RTSM, and monitoring in one place so that updates are easier than ever before.

Tuesday, October 1

09:30 AM – 10:15 AM
Better Forms, Better Data

If data is the lifeblood of a study, then forms are its arteries. The appearance, behavior, and “intelligence” of your eCRFs may be the greatest determinant of data quality. OpenClinica forms are designed to delight CRCs and participants, prompting accurate and timely entry with the aid of cross-form calculations, sophisticated skip logic, real-time edit checks, multimedia question types, autosave, and more. Take a brief tour of what OpenClinica forms have to offer as we proceed through an example study. You’ll leave with a newfound appreciation of the once humble, but now awesome, form.

Speakers: Bryan Farrow, eClinical Catalyst, OpenClinica

The Smart Mapper: A Machine Learning Tool for SDTM Mapping

Minnal is a Machine Learning platform for Clinical Data and Submissions Management, developed by Ratilan Technologies. The Smart Mapper, which will be showcased today, is one component of Minnal, and uses Machine Learning to automate SDTM Mapping.
Presenters: Eric Weising and Tarun Prashanth

How Liquid Data Takes us Beyond Data Management 2.0

…toward a new future: Data Management²

Medidata is developing a unified and protocol-aware platform that makes all of your data – irrespective of its source – liquid. The result: you will know exactly when you’re “done,” get to “done” faster, and have full visibility into the journey your data has taken from point of capture to “done.”

Join us for this live demonstration to learn how Medidata’s latest solutions can make your data liquid and how this enables a fundamentally new approach to Data Management.

Next Generation Data Review Using the elluminate Clinical Data Hub.

eClinical Solutions will be presenting the elluminate Clinical Data Hub in the product showcase. See how  elluminate Data Central is helping to transform and automate the process of clinical data review and management. The elluminate Data Central module allows for comprehensive data review across all data sources and enables an automated data pipeline for next generation data management. Learn more about how elluminate data central can transform the data review process with;

  • Incremental data review enabling data managers to focus on the data that has been changed since last review
  • Issue and query management workflow streamlining data questions to numerous source systems
  • Interactive patient profiles for review by safety and medical monitors

Tuesday, October 1

12:30 PM – 01:15 PM
Dacima Clinical Suite: Tired of Having to Fit a Square peg in a Round Whole – Dacima Takes EDC to a Whole New Level of Study Design!

Tired of EDCs that limit your design capabilities. Dacima Clinical suite is an advanced cloud EDC platform with integrated modules for IWRS, Supply Management, ePRO, eDiary, medical coding, eConsent and monitoring, that let you go beyond what is possible with traditional EDCs. The system is the most configurable EDC on the market with powerful and advanced design features that let you create more sophisticated, visually engaging and user-friendly eCRFs. Eliminate the need to use different systems for different study designs. With Dacima Clinical Suite, one system lets you configure and tailor your study workflows and interface for all kinds of study designs, including RCTs, Registries, Observations designs, chart review studies, ePRO, web surveys and more.  This session will show you how Dacima has taken EDC to a whole new level of study and eCRF design.

Streamlined Data Processing Strategies with Emerging Data Source
Presented by Julie Smiley, Sr. Director Life Sciences Product Strategy

Clinical data diversity and volume is growing rapidly, leaving traditional clinical trial programming methods unsustainable. Single artifact, duplicate programming is slow, resource intensive, and costly. In this session, learn why many of the top biopharma companies are moving to enterprise clinical data management solutions that focus on centralized aggregation and cleaning of study data from multiple sources to produce consumer data outputs more efficiently, resulting in greater quality and transparency.

In this session, the audience will learn about strategies and tools to:
• Reduce study cycle times while increasing operational flexibility
• Increase regulatory compliance while reducing operational costs
• Reduce risk while gaining faster insights from the data

Leveraging the power of standardized data from Wearables
eCOA and EHR to pave the way for decentralized trials.

Patient centric, decentralized trials have many advantages over more traditional trials, but bring their own challenges with regards to both data quality and large volumes of data.

In this session we will discuss how standardizing data at the source can allow researchers to leverage the power standardized data to support decentralized trials.

We will demonstrate how the Castor platform simplifies the process of capturing data from eCRFs, ePRO, EHR and Wearables into one easy to manage and user friendly database.

We will showcase our proof of concept technology for enrollment and data driven patient adherence tracking in decentralized trials.

EHR-to-EDC is Finally Here!

For decades, integration between EHR and EDC systems has been seen as the “holy grail” to optimize clinical research. Finally, key technologies and standards are now making such integration a reality. The presenter will explain how SMART and FHIR on the EHR side and CDISC ODM on the EDC side allow for scalable integration. The speaker will describe the solution developed by Clinical Pipe and implemented successfully in oncology clinical trials across multiple academic clinical trial centers. Clinical Pipe uses real-time API connectivity to populate EHR data into EDC. As of July 2019, the application integrates with all leading EHR systems and export data in real time to Medidata Rave and Oracle InForm, among others. The speaker will also address adoption across research institutions and sponsors/CROs, as well as discuss downstream operational impacts of acquiring data “automatically” from the EHR.