Cambridge Healthtech Institute’s Seventh Annual

Electronic Data in Clinical Trials

Collecting and Leveraging Data to Optimize Clinical Trials
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL

Electronic data capture systems had revolutionized the way clinical trials are performed. E-clinical technology is getting more sophisticated every year; and every year it faces new challenges and changes induced by the changing landscape of clinical research industry and healthcare IT in general. Cambridge Healthtech Institute’s Seventh Annual Electronic Data in Clinical Trials conference is designed to bring together experts in clinical IT from pharmaceutical and biotech companies as well as from  CROs to discuss the novel technologies and strategies to increase effectiveness and accuracy of clinical trials.

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Leveraging Clinical Trial Data

Tuesday, February 24

7:30 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks
van der Post_KunoKuno van der Post, Ph.D., Senior Vice President, Business Development, OmniComm Systems, Inc.




10:50 Roche Biometrics and the Evolving New Medical Data Landscape: The Plan, Opportunities & Challenges

Francis KendallFrancis Kendall, Global Head, Statistical Programming and Analysis, GLIDE Future Investigation Team Lead, Genentech

This talk will look at the challenges and opportunities the new Medical data Landscape for Pharma brings, and how Roche are setting the foundation with implement a new systems. Roche has explored what was the best approach and systems to implement and is now at the start of it implementation phase. The talk will explain how we got here and what is next...

11:15 What RBM Needs: Breaking Down the System and Functional Silos

Andy LawtonAndy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

RBM requires a holistic approach from the whole clinical team from the initial assessment through to risk reporting at the end of the trial. The systems that we use are not conducive to such cross-functional approaches. This presentation describes an integrated approach centred around a web-based tool, that allows the integration of onsite and central monitoring, and also facilitates a directed onsite monitoring strategy based on the regular risk assessment centrally and from the onsite monitor.

11:40 Driving Innovation in Clinical Data Standards, Technology and Processes

Raj BandaruRaj Bandaru, Informatics Science Director, AstraZeneca Pharmaceuticals

The confluence of mobile technology, high through put genomics, and big data analytics are enabling the shift in drug development to a more personalized and patient centric paradigm. We are exploring several developments in this space to fully realize the potential of our drug portfolio. But there are challenges that need to be addressed. In addition, sustaining innovation in operatons under a regulated environment can also be challenging. Taking a value chain approach to implement innovative approaches in clinical operations can be promising and I will share some approaches in driving innovation in AstraZeneca.

12:05 pm Designing Innovation: Using eSource to Streamline Clinical Trials

Ed SeguineEd Seguine, CEO, Clinical Ink

The rising cost and complexity of clinical trials requires a willingness to do new things – often with the help of novel technology. This presentation will explore how data capture has evolved to enable more innovative approaches like risk-based monitoring and adaptive design. We will use case studies to demonstrate how forward-thinking companies are streamlining and innovating clinical development via electronic source (eSource) data capture.

OmniComm12:35 LUNCHEON PRESENTATION: Practical Considerations for eSource
Howells_KeithKeith Howells, Senior Vice President, Product Development, OmniComm Systems, Inc.
The recent FDA guidance on eSource in clinical investigations lays out the expected processes and controls when clinical data is populated directly from electronic instruments rather than being transcribed from paper records. This session will cover some of the practical considerations in implementing eSource, such as how to communicate from an instrument to a web-based EDC system, manage the audit trail when the source instrument and the eCRF may have different timestamps, and facilitate monitoring and regulatory inspections for eSource data.

1:15 Session Break


1:25 Chairperson’s Remarks

Kirstin Holzapfel, Head, Clinical Data Process Technology, Global Clinical Data Center, Bayer / Global Clinical Operations

1:30 Implementing Innovative Clinical IT Technologies: The Bayer Approach

Kirstin HolzapfelKirstin Holzapfel, Head, Clinical Data Process Technology, Global Clinical Data Center, Bayer / Global Clinical Operations

It seems to be the right time for a change in the way how Bayer processes clinical study data. Contrary to the phrase: “never change a running system” it became necessary to streamline processes and renew the underlying IT infrastructure. Focused on study setup, conduct and analysis Bayer strives for managing the split between flexible data structures supporting data cleaning and review on the one hand und CDISC requirements on the other hand. Innovative technologies are seen as the key for success.

1:55 The Diffusion of Mobile and Data Sensors into Clinical Trials

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

Will the use of mobile tools and data sensors in clinical trials reshape the landscape and modernize the current trial execution model? The diffusion of mobile solutions and sensors will unleash an unprecedented amount of data and create the opportunity to make clinical trials cheaper and easier to execute, while also improving data accuracy.

Can we leverage the power of mobile and data sensors to:

  • Improve clinical trial operations while reducing costs
  • Generate data-driven insights to inform drug efficacy
  • Drive innovation in patient outcomes
  • Transform the clinical trial experience for key stakeholders

2:20 Whispering: Iteratively Specifying, Refining, and Exercising Your Data Model Prior to Deploying Your Study to the Production Platform(s)

John PerkinsJohn Perkins, Application Architect, MAVERIC Boston CSP Coordinating Center, Department of Veterans Affairs

Although collection mechanisms vary from study to study due to logistical constraints, the data modeling needs of studies, including collection, storage, reporting, monitoring, and analysis, are inherently tool and platform independent. Learn how Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) uses a process we call Whispering combining generation techniques and freely available Veteran Affairs enterprise tools such as SharePoint, InfoPath, SQL Server, Access, Excel, and Word to insure the study team iteratively refines and exercises the data model prior to first patient and independent of production tools and platforms.

2:45 Do You Know if Your Study Participants are Taking Their Medication? Learn How Artificial Intelligence Can Help Reduce the Risk of Trial Failure

Hanina_AdamAdam Hanina, CEO, AiCure

While sites are responsible for data quality and patient safety, the type of extensive and costly participant monitoring usually available in Phase 1 – which guarantees the highest level of human subjects protection and study data integrity – is dropped in later phase trials once the patient leaves the site. AiCure has developed a new gold standard to centralize subject monitoring and medication ingestion through artificial intelligence.


3:00 Refreshment Break in the Exhibit Hall

4:00 Find Your Table and Meet Your Moderator

4:05 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

View Detailed Interactive Breakout Discussion Groups

5:00 Welcome Reception in the Exhibit Hall

6:15 Close of Day

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Leveraging Clinical Trial Data

Wednesday, February 25

7:30 am BREAKFAST PRESENTATION: Evaluating the ROI of Outsourcing Investigator Payments

Stuart ThiedeStuart (Stu) Thiede, President, DrugDev Payments

Everyone knows the # 1 complaint of Investigators is slow payments to the sites. Pharmaceutical companies often outsource investigator payments to improve efficiencies, provide costs savings and build better investigator relationships. But how do you quantify whether or not you made the right decision to outsource? Do you go with anecdotal evidence and assume your goals are being realized or can you prove it with real metrics? This program will review a model that enables you to assess the ROI of outsourcing your investigator payments. See how this model measures benefits such as increased operational efficiencies, enhanced investigator relationships, improved budget management and increased compliance to determine whether or not you’re accomplishing your business objectives.

8:25 Plenary Keynote Session

9:45 Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks
Seguine_EdEd Seguine, CEO, Clinical Ink




10:50 SIOP/CMSO – Risk-Based Strategy to Monitor and Mitigate Threats to Clinical Trial Scientific Integrity

Kenneth Mark MillsKenneth Mark Mills, Director, Clinical Scientific Data Warehouse, Pfizer

Oversight of scientific integrity in ongoing trials is an important component of clinical/medical review. Monitoring adherence to protocol requirements and ensuring that the assumptions made during trial design are not being grossly violated as the trial unfolds is an important aspect of blinded aggregate data review. Such a proactive data monitoring strategy serves to optimize trial outcomes and ensure that the study yields results that are more likely to answer the primary research question and stand up to scrutiny of regulators and scientific peer review. The presentation will provide insight into processes and tools used to support Pfizer’s strategy for monitoring study scientific integrity.

11:15 Doing More, Faster, Better! How CDISC Data Standards Shorten the Clinical Trial Life Cycle Across the Globe

Vincent AmoruccioVincent Amoruccio, Director, Clinical and Statistical Programming, Alexion Pharmaceuticals

The primary goal of the pharmaceutical industry is to develop, produce, and market life changing and life saving drugs as quickly as possible but with the highest quality and standards possible. CDISC data standards offer significant improvements in clinical trial operations. This presentation will address the regulatory requirements for CDISC in the countries that make up 85% of the market and how CDISC can get medications to the public faster.

11:40 How the Exostar/SAFE-BioPharma Alliance Is Optimizing Drug Development and Clinical Trials

Mollie Shields-UehlingMollie Shields-Uehling, President and CEO, Corporate Headquarters, SAFE-BioPharma Association

Tom Johnson, Senior Director, Life Science Product Management, Exostar

The centralized research model is moving toward a distributed global model leveraging the cloud to improve communications, information sharing, and collaboration with external partners. This change in paradigm for clinical trials comes with an increase in security risk, data control and greater need for IP protection. Large Pharma companies who recognize the need for joint development must adopt a secure cloud access solution that enables greater access to partner information and applications while maintaining a federated, trusted environment. This presentation will provide use cases from current Pharma customers utilizing federated identity services to enable cloud based research and development.

12:05 pm Simplifying the Investigator Experience by Using a Single ID

Tom JohnsonTom Johnson, Senior Director, Life Science Product Management, Exostar

Life sciences organizations are fundamentally changing the way they conduct and manage clinical trials. More and more, the biopharmaceutical industry is leveraging the resources and expertise of their partners to gain greater efficiency. However, enabling these teams to quickly connect and share information creates new risks to security, data control and the protection of intellectual property proportional to the increased levels of access. This presentation will demonstrate how utilizing a single managed ID can enable secure collaboration in the cloud with critical partners without compromising security.

12:35 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 Session Break/Close of Conference

Tuesday | Wednesday | Track Brochure | Full Event Brochure
Stay on for Part 2: Leveraging Clinical Trial Data

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In Memory of Gerald “Jerry” Matczak
Matczak Jerry

Gerald “Jerry” Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

– Cambridge Healthtech Institute (CHI)