Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit

Cambridge Healthtech Institute’s Sixth Annual
Clinical Trial Auditing
Building Effective Audit Programs

May 10-11, 2016 | Westin Boston Waterfront | Boston, MA


A comprehensive quality management system is crucial to ensuring the two objectives of clinical trial quality – patient safety and data quality. Implementing quality standards coupled with establishing effective audit teams leads to more compliant, higher quality clinical trials. Cambridge Healthtech Institute’s “Clinical Trial Auditing” conference offers case studies and best practices on establishing effective audit teams, auditing practices, and CAPA plans.


Corrective and Preventive Actions (CAPAs) for Clinical Trials

CAPA as Part of Quality Systems in Academia

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami


Risk-Based Auditing

Risk-Based Auditing at Allergan

Janis Little, Vice President, Global R&D Quality, Allergan

Science-Based Auditing Of Clinical Trials

Amer Alghabban, Vice President, GxP QA, Compliance & Training, GxP Quality Assurance, Karyopharm Therapeutics Inc.


Vendor Performance, Quality and Metrics

Partnering Quality with our Quality Partners: Managing Clinical Trial Quality through Oversight and Collaboration with Our CRO Partners

Christine Block, ‎Executive Director, Quality Assurance GCP, Incyte

Issue Escalation for Fully Outsourced Studies

Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb

So I Contracted with My Vendor…Now What?!

Tenley Koepnick, Head of Clinical Vendor Oversight; Director, Drug Development Operations, Allergan

Vendor/Sponsor Performance Metrics. How Are We Doing?

Randy Krauss, Director, Clinical Performance Metrics, Alexion

PANEL: Project Tracking and Establishing Appropriate Metrics from both the Sponsor & CRO Perspective 

Tenley Koepnick, Head of Clinical Vendor Oversight; Director, Drug Development Operations, Allergan  

Randy Krauss, Director, Clinical Performance Metrics, Alexion

Timothy S. LaCroix, MBA, Head, Business Development, PharPoint Research, Inc.




To submit a speaker proposal for Clinical Trial Innovation Summit 2016, please click here.

For questions or suggestions about the meeting, please contact:
Lee Yuan
Associate Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5404
E: lyuan@healthtech.com

For media and association partnerships, please contact:
Jaime Hodges
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5429
E: jhodges@healthtech.com

For partnering and sponsorship information, please contact:
Ilana Quigley
Sr Business Development Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com