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Tuesday, March 9, 2010
7:45 AM Morning Coffee or Sponsored Breakfast Presentation (Sponsorship Opportunity Available)
8:40 Chairperson’s Remarks
Ingrid Akerblom, Executive Director, Development IT, Merck & Co., Inc.
8:45 Incorporating and Integrating the eClinical Systems and Practices of Two Organizations
Ed Kellar, EDC Implementation Leader, Wyeth
Sponsors and vendors alike are in a period of rapid consolidation, which is expected to continue. The benefits to consumers and shareholders are widely discussed, but how are other stakeholders affected? In this session we will discuss the impact on eClinical excellence, including: the integration of technologies, likely strategies to assimilate best practices and processes, and the effect on the people and the culture of the combined companies.
Sponsored by
9:15 Independent Electronic Adjudication of Patient Eligibility and Clinical Endpoints in Local and Global Clinical Trials
Drew Kilpatrick, M.D., Director, Global Safety and Pharmacovigilance, Kendle
Traditionally, adjudication of clinical endpoints has involved a paper based approach. Replacement of paper by electronic adjudication offers several process/cost advantages to sponsors of clinical trials. When the electronic adjudication system is linked to IVR/IWR systems/eCRF, it is possible to independently adjudicate that a patient should be randomized into a study and b) identify when a patient has reported a potential clinical endpoint. Furthermore, the electronic approach allows adjudicators to access the system from anywhere in the world, review the corresponding endpoint documentation and complete the electronic adjudication form, confirming (or not) that the event reported by the patient is an endpoint as defined in the protocol.
Sponsored by
9:45 Increasing Clinical Trial Efficiency through Operational Data Management
Bob Webber, President and CEO, TranSenda International, LLC
Clinical trial professionals are faced with managing studies that involve a myriad of disconnected software applications, each with a unique database and user interface. Even after costly point-to-point integration, users need to deal with a number of different systems to extract information. The future of clinical trial management is a portal environment that translates data from multiple clinical systems into targeted user information based upon role and access permissions, leveraging the latest software technologies like Microsoft Office SharePoint Server. This session will include real-world examples.
10:00 Networking Coffee Break and Exhibit Viewing
10:40 Chairperson’s Remarks
Ingrid Akerblom, Executive Director, Development IT, Merck & Co., Inc.
10:45 Integrating SAE and AE Best Practice
Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.
The topic of SAE integration is a current topic that benefits all companies and an issue whose challenges need to be met. This presentation will summarize considerations for moving SAE data into an EDC system. How do we start? Where do we go? And how do we get there? Collated experiences from several companies and discussion of the SAE to EDC Checklist that was developed will be presented.
11:15 Interactive Panel: Overcoming the Challenge of Integrating Safety Reporting Data into your EDC System
This panel will discuss collection of Drug Safety serious adverse event data through an EDC system and the subsequent transfer of these data to the Drug Safety database.
What are the major issues companies encounter when tackling integration of drug safety data collection into company-wide EDC systems? What are the pitfalls and lessons learned when addressing different perspectives of clinical trial data collection vs. safety reporting from a technical and organizational perspective? How have different companies accomplished this? What was the impact on or between the drug safety and clinical research departments? What organizational best practices can be learned?
Moderator: Steven Olsen, M.S., Principal, SJO Consulting, LLC
Rachel Shah, MPH, CCDM, Senior Clinical Data Associate, Gilead Sciences
Michael Goedde, Director, Clinical Data Management, HGS (Human Genome Sciences)
Darlene Kalinowski, Associate Director, eDC Operations, Bristol-Myers Squibb Co.
Jonathan S. Helfgott, Consumer Safety Officer, CDRH, Office of Compliance, Division of Bioresearch Monitoring, FDA
11:45 Post-Panel Q&A with FDA: Discuss Compliance Issues on the Use of Computerized Systems in Clinical Investigations
 Jonathan S. Helfgott, Consumer Safety Officer, CDRH, Office of Compliance, Division of Bioresearch Monitoring, FDA
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12:00 PM Luncheon Presentation (Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on Your Own
1:25 Chairperson’s Remarks:
Susan K. Howard, Therapeutic Program Manager, Oncology Data Management, GlaxoSmithKline
1:30 Clinical Observations Interoperability: Leveraging Semantics for Effective and Accurate Sharing of Clinical Data
Vipul Kashyap, Director, Applied Informatics, CIGNA
The imperative to control rising healthcare costs and yet achieve optimum outcomes suggests the need for holistic services to deliver optimum therapy and care for patients. Those services embrace biomedical research, clinical research and practice. Re-use of clinical data is also beneficial to healthcare providers, e.g., evaluating clinical care quality; payors, e.g., monitoring patient risk profile, and pharma, e.g., determining patient eligibility for clinical trials, monitoring adverse events during and after trials. We propose an extensible framework and architecture for sharing and exchange of clinical data. This is illustrated via a demonstration utilizing eligibility specifications from several clinical research protocols (using the CDISC-based standards) and (structured) patient data from a real world EHR (using HL7-based standards) to screen the EHR data for potential candidates.
2:00 The Highway to Successful Data Integration in Clinical Trials, Without Taking the Wrong Exits
Michael Goedde, Director, Clinical Data Management, HGS (Human Genome Sciences)
Starting with some basic background information and definitions on data integration, this presentation will deal with the question, if technical hurdles are truly the biggest challenge in the effort of companies to integrate clinical data or if there are other aspects that could result in bigger roadblocks. It will also look into different approaches for successful data integration for BioTech, small pharma and big pharma. After sharing experiences of different integration models this presentation will also try to raise questions around ROI of integrating data.
Sponsored by
2:30 Integration in eClinical Trials World - A Critical Path Perspective
Ram Kamath, CEO, Vsoft Infoware, Inc.
Clinical trials are becoming increasingly complex and data collection a significant challenge with global trials. In a landscape of over 150 vendors/applications and over 100 IT staff, simplification through integration has become inevitable. Critical path initiatives are the driving force behind improvement in the success rate of trial.
• Features of silo-based solutions with glue-on approach
• Adaptive/Seamless-phase trials and its advantages
• How to make clinical trials more worry-free
• Transition from paper to eClinical world and from partial integration to full integration
• Move to Infoware with single information repository based transactional and reporting system
2:45 Networking Refreshment Break and Exhibit Viewing
3:30 Development and Implementation of a Standard Methodology for the Assessment of Sites that have EMR/EHR Systems for Support of Drug Development
Aaron Kamauu, M.D., Healthcare Data Strategy, Biometrics, Roche
We have developed a standard methodology for assessing sites with EMR/EHR systems for the direct support of drug development programs/clinical trials. This includes assessment of their data content/quality, technical capabilities, biomedical informatics capabilities and past experience using EMR/EHR data in support of clinical research and/or drug development. Herein we present this methodology and its application to specific drug projects.
4:00 EDC and Data Quality
Reza Rostami, MBA, CCDM, RAC, Assistant Director, Quality Assurance & Regulatory Compliance, Duke Clinical Research Institute, Duke University Medical Center
Transitioning from paper-based data collection to electronic data capture (EDC) systems has resulted in much measurable efficiency such as quick data availability and fast database lock. However, the level of data quality is more perceived than empirically measured. To date, data that demonstrate high levels of quality of electronically collected data are very limited and inconclusive. The main source of error in paper-based trials was data extracted from the patient chart and transcribed to the CRF. This activity stays the same with EDC: data is extracted from patient charts and entered into the system. To use an EDC system with confidence, data managers, programmers, and managers must understand how this new technology and processes affect data quality. This presentation will address techniques for measuring data quality, provide examples of published evidence of data quality in EDC, and recommend steps to assure a higher data quality.
4:30 Standards in Your Future: How SAFE-BioPharma, IHE and CDISC are Collaborating to Improve Safety Reporting
Rich Furr, Head, Global Regulatory Affairs and Chief Compliance Officer, Headquarters, SAFE-BioPharma Association
Reliance on paper forms is a major obstacle preventing the clinical investigation process from becoming fully electronic. Signing, handling, archiving and storing paper is expensive, error-prone and time-consuming. This presentation will explain a collaboration by three industry standards groups to achieve faster safety trend analysis, data mining and data migration from electronic health records 1) to archived and digitally signed electronic case report forms and 2) to individual case safety report forms.
5:00 Close of Electronic Data in Clinical Trials Conference
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