9th Clinical Quality Oversight Forum – 9th Clinical Quality Oversight Forum

ExL’s 9th Clinical Quality Oversight Forum focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. This forum acts as the annual gathering for clinical quality, operations, management and audit professionals to engage and candidly share their experiences, struggles, obstacles, and achievements when working with varying clinical partners including CROs and investigator sites. Learn from this experienced group and take away proven, results-driven, risk-based strategies for optimizing your company’s clinical vendor and site oversight approach.

Event Features

CHAIRPERSON

Angela Berns,
Director and Head of Vendor Management,
UCB BIOSCIENCES INC.

INDUSTRY SURVEY RESULTS: CRO OVERSIGHT EFFECTIVENESS AND IMPACT

Benchmarking and Understanding the Industry’s CRO Oversight Practices, Their Impact, and Effectiveness With New Industry Research Results
Kenneth A. Getz, MBA,
Chairman, CISCRP; Director of Sponsored Research,
TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Beth Harper,
President,
CLINICAL PERFORMANCE PARTNERS, INC.

REAL CASE STUDIES OF AVOIDABLE FAILURES

Examining Fundamental Failures by Top CROs Identified Through Audits, and How Effective Oversight Would Have Prevented Them
Sharon Reinhard, M.S.,
Clinical Compliance Solutions, Consultant on Assignment,
MERCK

Top Five Reasons to Attend

  • Learn from the industry’s leading clinical operations and quality experts as they candidly share their experiences, strategies, and guidance for selecting and managing your clinical partners to ensure compliance and maximize performance.
  • Benchmark your clinical quality oversight strategy against other similar-sized companies to ensure your approach is optimal and effective.
  • Integrate a risk-based, resource-optimizing approach for effective selection, monitoring and long-term management of your clinical vendors and sites.
  • Position your trial for success by ensuring your clinical vendors and sites are inspection ready with the latest tools, technologies and audit strategies.
  • Design your own agenda and choose your preferred learning environment with the selection of interactive workshops, session tracks, educational presentations, dynamic panels, interactive roundtables and ample networking opportunities.

Who Should Attend

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Quality Management/Clinical Quality Management
    • Clinical Quality Assurance/QA/CQA
    • Clinical Quality Control/QC/CQC
  • Clinical Operations/Management/Research/Development
  • Compliance/Clinical Compliance/Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Outsourcing/Vendor Management/Third Party Management
  • Good Clinical Practice/GCP
  • Auditing/Auditor
  • Clinical Risk/Risk Assessment
  • Regulatory Affairs
  • Medical Affairs

The event is also of interest to:

  • Investigative Sites
  • Academic Research Organizations
  • Central, Imaging and ECG Labs
  • IVRS Companies
  • EDC Companies
  • Other Clinical Service Providers