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Wednesday, June 27 • 8:00am - 9:15am
#304: Data and Quality Approaches to Informing Global Investigative Site Selection

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-625-L04-P; CME 1.25; IACET 1.25; RN 1.25

Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative (CTTI) has worked to critically evaluate current approaches to investigator qualification, including GCP training, and develop recommendations on efficient and effective methods for investigators to become qualified to conduct clinical trials. This session will also describe these recommendations, focusing on the merit and value of the directives, as well as sharing insight from multiple stakeholder perspectives on how to implement these changes in practice.

Learning Objectives

Assess current industry trends and strategies on end-to-end site identification; Assess data available through public databases to aid in site selection.

Chair

Stella Stergiopoulos

Speaker

Challenges and Solutions in Integrating Data Sources to Support Evidence-Based Site Selection and Study Planning
Claire Sears, PhD

Empowering our Investigators: How New Investigator Qualification Approaches Could Improve Quality Conduct of Clinical Trials
James Kremidas


Speakers
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →
avatar for Claire Sears

Claire Sears

Communications Director, Data Solutions, DrugDev
Claire Sears joined DrugDev early in 2013, where she is currently Director, Product Communications for the Data Solutions team, leading communications and training activities for the TransCelerate Investigator Registry, and for Investigator Databank. With a background in academia... Read More →
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Research Fellow, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos leads multi-sponsored research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session