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Monday, October 21, 2013 | 8:30 - 11:00 am

Key Technical, Scientific and Operational Considerations in Conducting a Patient-Centric Study

Technology continues to grow at an exponential rate and is allowing us to incorporate new and innovative concepts into clinical trials. By leveraging these technologies and newer communication channels, studies can be designed so part or all of a study can be executed without the need for investigative sites. Patient-centric studies are more in demand than ever before, however, new concepts and procedures bring an entirely new set of considerations that must be carefully thought through before starting any clinical trial.

Attendees will learn the most important technological, scientific and operational considerations when designing and executing a patient centric study:

  • How to collect and share data with patients using the latest technologies and tools: EDC systems, smartphones, social media, wireless medical devices and more
  • Scientific design considerations such as targeting the right patient population, selecting study endpoints, including a control group, etc.
  • Operational study enhancements, such as utilizing centralized clinics, pharmacies and home health nurses
  • During the workshop, attendees will divide into teams to work through a sample study design



Nancy Mulligan Nancy Mulligan, Senior Director, Operations, Patient and Physician Services, United BioSource Corporation 

Ms. Mulligan has over 22 years of experience in medical and pharmaceutical communications. In her current position at Patient & Physician Services for UBC, she manages an in-house team of medical writers, designers, production and communications professionals all focused on designing and executing aggressive, multi-media initiatives and site-based programs for various stakeholders. Ms. Mulligan is responsible for program operations of all TES strategies and vehicles that support physicians and patients, including recruitment and retention programs for research studies. Prior to joining UBC, Ms. Mulligan was a consultant with Booz Allen Hamilton and served as Vice President at Matthews Media Group. She holds a B.S. in Communications from University of Massachusetts.

Krista PayneKrista Payne, Executive Director, Value Demonstration within Peri- and Post-Approval Services; Senior Research Scientist, United BioSource Corporation 

Ms. Payne, BA (Hons), MEd, is responsible for the conceptualization, design, and implementation of observational studies and registries including burden of illness evaluations and disease, national and multi-national direct-to-patient surveys, retrospective chart reviews, as well as product and safety registries. Ms. Payne has almost 20 years of pharmacoeconomic and research experience ranging from oncology, cardiology, and neurology, to pulmonology and gastrointestinal indications. Ms. Payne has designed and executed various multi-national observational studies and registries, including prospective and retrospective data collection projects in more than 14 countries around the world.

Halleluya DunnHalleluya Dunn, Clinical Recruitment Manager, Patient & Physician Services, United BioSource Corporation 

Mrs. Dunn is an Operations Manager with extensive experience in the clinical research field. At UBC, she oversees the execution of patient recruitment and retention programs for both clinical and post-marketing programs across a wide array of therapeutic areas, including neurology, gastroenterology, and oncology. Mrs. Dunn comes to UBC with 8 years of clinical research experience as a trial manager for domestic and international Phase I-IV studies with Intercell USA Inc., Technical Resources International and CONRAD. In her previous roles she managed aspects of recruitment, regulatory submissions, and the general logistics of conducting clinical trials in the U.S and the rest of the world.



*Separate registration required



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