Cambridge Healthtech Institute’s Fourth Annual  

Integrating and Leveraging Clinical Trial Operations Data  

Novel Integrative Systems, Visual Analytics, Performance Metrics

February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL

We are witnessing an unprecedented burst of technology that completely changes the way we run clinical trials. The use of technology in the support of Clinical Trials has continued to increase including solutions such as Investigator Portal, EDC, IRT, ePRO, etc. Cambridge Healthtech Institute’s Fourth Annual Integrating and Leveraging Clinical Trial Operations Data conference will feature an array of topics such as data integration and accessibility, novel data visualization technologies, data sensors and others.

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Electronic Data

Wednesday, February 25


Intrinsic_ClinicalSystems1:25 pm Chairperson’s Remarks

Matt KiernanMatt Kiernan, Partner, Pharmica Consulting


1:30 Next-Generation Data Visualization and Collaboration

Ed KellarEd Kellar, Director, Global Data Management Operational Support, Data Management, Astellas

In an effort to streamline clinical, operational and safety data analysis at Astellas, advanced analytics and event-driven collaboration capabilities were employed worldwide. The key to the system is a novel clinical data review tool built around a virtual on-demand data warehouse that provides dependable decision making based on a single source of truth. The solution equipped end users with the ability to perform self-service data discovery and report building without having to rely on IT or biostatistics for report generation so they could focus on higher value-add tasks.

1:55 Using English Language Queries To Gain Insights Into Clinical Data

Munther BaaraMunther Baara, Senior Director, Development Business Technology, Pfizer

Clinical staff have traditionally had to work with programmers in an iterative process to gain insights into clinical data. Using revolutionary technology, users are able to gain insights into the data by asking questions in plain English. At Pfizer, we piloted the use of this technology to augment our Enhanced Quantitative Drug Design process for selected studies related to our product. I will share the outcome of our pilot.”

2:20 Visual Analytics: Sailing Big Data in Clinical Research

Charles RomanoCharles Romano, Senior Director, Clinical Research, Amniox Medical

Whether designing a hot new study or standing in the remnants of a terminated project, determining whether a program is excelling or stalling is an old science with some new tools. With millions of dollars, new indications and patients’ lives depending on our innovation, what do you watch in the spyglass to see where your program is going? In this session, we will examine some useful measures for study startup, execution and conclusion.

2:45 Integrating and Leveraging Clinical Trial Operations Data to Improve your TMF

Jennifer GoldsmithJennifer Goldsmith, Vice President, Vault R&D, Veeva
A 2014 industry wide survey revealed the extent to which leveraging clinical trials operations data can improve study quality and efficiency. This session will share results from the largest TMF survey to date and describe an electronic TMF operating model that provides immediate insight into TMF quality and drives overall business operations. When organizations can measure key factors like site performance – drilling down across studies, therapeutic areas, geographies – and leverage that data to improve the site selection and activation processes enormous efficiencies are gained. 


3:15 Refreshment Break in the Exhibit Hall


4:05 Chairperson’s Remarks

Ozgur Ozkan, Ph.D., Principal Decision Scientist, Biometrics and Information Sciences, AstraZeneca

4:10 Meeting Recruitment Targets: Improving Your Chances to Randomize That Last Subject on Time

Ozgur OzkanOzgur Ozkan, Ph.D., Principal Decision Scientist, Biometrics and Information Sciences, AstraZeneca

Accurate estimation of recruitment performance as well as better assessment of alternative strategies could improve the delivery of clinical studies. For this purpose, a model is developed to track activities at country, site and patient level and simulate trial progress given actual and planned performance. The model is used to estimate the probability distribution of time to randomize the last patient and calculate confidence in completing recruitment by planned timeline. The approach is tested with ongoing trials and alternative strategies are evaluated.

Thomson Reuters4:35 Leveraging Internal and External Data through Semantic Web Technology to Identify New Sites and Investigators

Comis-Tis_LarissaLarissa Comis Tis M.J., Director, Clinical, Thomson Reuters

Thomson Reuters Cortellis™ Data Fusion (formerly Entagen’s Extera) enables new scientific and strategic insights by connecting your proprietary content with the world's data, utilizing Big Data and Linked Data technologies. A powerful data core technology is used to aggregate entities and create associations between them, enabling organizations to securely integrate Life Sciences content from a variety of sources. Cortellis Data Fusion is the leading technology to explore hidden relationships between data entities and is used by top pharma and research institutions for applications such as target finding, drug repurposing, and precision medicine. Discover how to leverage Cortellis Data Fusion in Clinical Operations to find new relationships between investigators, sites, trials and epi-data.

4:50 Technology Framework to Operationalize Precision Medicine

Michael Swietek, Principal Scientist, Informatics, Pfizer, Inc.

Biomarkers become an integral part of clinical trials. In order to run a biomarker-driven trial we need to put in place an effective system of sample and biospecimen management and tracking. IT technologies come instrumental in this process. This talk will discuss the use of a specimen management framework to operationalize biomarker- focused clinical research and the precision medicine development.


5:15 CO-PRESENTATION: Using Clinical Dashboard to Drive Clinical Trial Metrics Improvement

Ron BourqueRon Bourque, R&D IS Senior Manager, Clinical Business Management and Analytics, MedImmune


Graham IrvineGraham Irvine, Director, Therapeutic Area & Capacity Management, MedImmune


MedImmune has developed a clinical dashboard to drive clinical trial metrics improvement and operational information compliance. The dashboard utilizes project management and operational data from major clinical systems and provides an easy access and view of trial summary information and key metrics information. It enables R&D executive review and study teams’ review. It provides a single source of truth of critical clinical management information. The dashboard technology also enables view of information from mobile devices such as iPad and iPhone.

5:40 Reception in the Exhibit Hall

7:00 Close of Day

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Electronic Data

Thursday, February 26

7:30 am BREAKFAST PRESENTATION: What’s New in Protocol Feasibility: An Exploration of the Six Key Elements of Data-Driven Feasibility and What Has Changed

Chris FregaChris Frega, Senior Director, Head, Global Feasibility & Patient Recruitment, Quintiles
The process for conducting protocol feasibility and developing operational strategies has been evolving along with the need for better and more robust planning for clinical studies. As a result, we must include the latest and most relevant data and insights in study planning. By using six data elements, trial managers can ensure the right data is utilized: company proprietary, public and commercial, sponsor, investigator perspectives/input, patient perspectives, and country/medical/operational experts.



8:15 Chairperson’s Remarks

Andrew Porter, Director, Enterprise Architecture, IT Planning and Innovation, Merck & Co.

8:20 CO-PRESENTATION: Real World Analytics in the Cloud: Fact or Fiction?

Patrick M. LoerchPatrick M. Loerch, Ph.D., Director, Health IT, Office of CIO, Merck & Co.


Andrew PorterAndrew Porter, Director, Enterprise Architecture, IT Planning and Innovation, Merck & Co.


How is it possible to conduct research in the cloud with so many restrictions on data from how it can be used, where it can be analyzed, and what it can be combined with. Combine these restrictions with the fact that data owners want stewardship over their data from who can use it, for what, and how long. The problem seems to be unsolvable. The Health Data Exchange (HDEX) is taking an aggressive approach to addressing these very issues along with many more.

8:55 CO-PRESENTATION: Workbench: Improving How We Progress the Portfolio

Eric GrandeEric Grande, Associate Director, Application Architecture, Novartis


David YeeDavid Yee, Ph.D., Translational Sciences Project Leader, IT & Process Improvement, Novartis


Novartis enjoys a rich portfolio with many projects in multiple disease areas managed across many line functions. As such, cross-functional coordination and alignment is challenging. We are designing a simplified environment to enable us to better communicate, collaborate, and manage our work. Our approach is to establish a modern platform based upon a common data model. The benefits of the Workbench include more agile decision making, reduced bureaucracy, and more efficient use of resources.

9:35 Risk Based Data Surveillance

Neri_NickNick Neri, eCI Platform Manager, ERT

Effective data surveillance is critical for ensuring safe and cost-effective clinical trials. With endpoint data being captured in multiple systems (EDC, IXR, Labs, eCOA), many companies rely on manual data preparation processes that are error-prone and resource intensive. Through a case study example, attendees will gain an understanding of how to automate the integration and visualization of endpoint and site performance data to achieve a holistic and real-time solution for data surveillance operations.

10:00 Coffee Break in the Exhibit Hall

10:40 Closing Plenary Keynote

1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)

Wednesday | Thursday | Track Brochure | Full Event Brochure
Arrive early and attend Part 1: Electronic Data

Signature Sponsor

Bio Clinica Logo

Premier Sponsors





PRA Health Sciences


> All Sponsors

> Media Partners

> 2016 Attendee List

> 2016 Attendee Profile