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Tuesday, June 26 • 8:00am - 9:00am
#209: Oversight in the Era of E6 (R2)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-18-562-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will outline the characteristics that define common outsourcing models and expose their corresponding risk/benefit ratio with regard to sponsor and CRO oversight. Case studies of proven solutions within each model will be presented and linked to recommendations to achieve enhanced oversight in the era of E6 (R2).

Learning Objectives

Discuss the risk/benefit ratio with regard to sponsor and CRO oversight in common outsourcing models; Identify methods to implement improved and more efficient approaches to clinical trial oversight.


Melissa Bomben, MS


Cristin MacDonald, PhD

Lauren Curtiss

Ann Marie Dunne, MPH

avatar for Melissa Bomben

Melissa Bomben

Vice President, Strategic Resourcing, Syneos Health
Melissa Bomben is Vice President, Strategic Resourcing with Syneos Health, an organization purpose-built to achieve a singular goal: Biopharmaceutical Acceleration. As an operational leader with over 20 years of experience, Melissa works directly with pharmaceutical development organizations... Read More →
avatar for Lauren Curtiss

Lauren Curtiss

GCP Inspection Lead, Merck & Co., Inc.
Lauren Curtiss is a GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. In this role, Lauren leads the preparation, notification, conduct and follow-up of Health Authority GCP inspections related to clinical studies sponsored by Merck worldwide... Read More →

Ann Marie Dunne

Director, Quality Operational Capabilities, Global Clinical Operations, Biogen
Accomplished clinical research professional with over 18 years experience in clinical project management, strategic program development and quality management/compliance.
avatar for Cristin MacDonald

Cristin MacDonald

Vice President, Client Delivery, The Avoca Group, United States
Dr. Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 5 years of pharmaceutical industry experience with expertise in clinical research... Read More →

Tuesday June 26, 2018 8:00am - 9:00am EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session