Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit
Archived Content

Barnett International and Cambridge Healthtech Institute’s
Clinical Quality Risk Management
Implementing a Comprehensive Quality Management
System for Good Clinical Practice

June 4-5, 2012 


Day 1 | Day 2 

Barnett International and Cambridge Healthtech Institute’s Inaugural Clinical Quality Risk Management conference will focus on meeting the emerging regulatory expectations for a quality systems-based approach to GCP compliance. FDA compliance officials are increasingly speaking about the importance of sponsors’ quality systems in clinical research, and of the shifting expectations for sponsors’ clinical trial oversight, in particular to a quality risk management approach in trial oversight. European regulators have also expressed interest in the topic, and are reportedly working on a risk-based quality management approach for clinical trial conduct and supervision. Thought leaders will share their experiences implementing clinical QRM, creating quality systems-based approaches to clinical monitoring and auditing that produces reliable data, and responding to the evolving regulatory landscape.

Monday, June 4, 2012

7:00 am Registration and Morning Coffee

8:15 Welcome & Chairperson’s Opening Remarks



Ken Schiff, B.A., M.B.A., Quality Risk Management Associates, LLC

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

8:30-9:30 Quality Risk Management in Clinical Trials and Pharmacovigilance

The ICH Q9 Quality Risk Management (QRM) guideline facilitates the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Similarly, but more recently (August 2011), both the EMA and the FDA published a reflection paper on the application of QRM in clinical trials and an industry guidance document on “Oversight of Clinical Investigations–A Risk-Based Approach to Monitoring,” respectively. Industry as well as regulatory bodies have recognized the need and benefits of implementing a risk-based approach to quality management, and are currently gearing up to accommodate this. This course is a timely response to this trend and is designed to provide its participants with a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. Learning objectives include:

  • Define Quality Management System (QMS) Levels for applicable areas in Clinical Trials and Pharmacovigilance
  • Build quality at key points in these processes
  • Apply QRM principles: Identification and Quantification of Key Risk Indicators (KRIs)
  • Implement a Quality by Design approach to overcome shortcomings in quality and compliance
  • Leverage existing information to support decision making in resource allocation within clinical trials
  • Create a governance model to support mitigation strategies and the overall QMS infrastructure

9:30-11:30 Building Quality at Key Points in the Clinical Trial Process: An Exercise in Developing Key Risk Indicators and Critical to Quality Metrics

Key to the success of QRM is the capacity to leverage existing information in such a way that stakeholders can easily assess whether the processes they are responsible for yield (or will yield) the intended results and quality. This approach helps organizations to proactively identify, manage, and mitigate risks before they manifest into real problems. A risk-based approach requires not only a strategy but tools to define leading and lagging indicators to measure specific risks. As referenced from the recent CTTI initiatives, Key Risk Indicators (KRIs) should focus on “what really matters” with an emphasis on patient safety and data integrity, and be tied to particular processes within the clinical drug development spectrum. This interactive session will provide participants with a strong conceptual foundation for defining what is a meaningful KRI across clinical trial processes, as well as the corresponding thresholds for acceptability of outcomes.

11:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Quality Systems-Based Approaches to Clinical Trial Monitoring 

1:00 pm FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials

Anne Marie Murphy, Principal, Hyman, Phelps & McNamara

The FDA recently issued draft guidance on risk-based clinical trial monitoring. The guidance recommends certain methods of risk-based monitoring for sponsors and CROs. The methods addressed include general monitoring requirements, identifying critical data and processes to be monitored, factors to consider when developing a risk-based plan, and on-site monitoring versus monitoring by certain electronic means of communication. The presentation will address key elements of the draft guidance, the expectations from industry when developing a monitoring/quality risk management plan, and practices for moving towards a risk-based approach. We will also review public feedback from the draft guidance comment period.

1:45 Clinical Site Issue Escalation: A Vital Process in Clinical Quality Management

Daniel J. Greenwood, Senior Associate Director, Compliance & Quality Management, Boehringer Ingelheim Pharmaceuticals, Inc.

One of the key elements of a quality management system is the monitoring of clinical trial sites either on-site or remotely via a centralized monitoring approach. When compliance and quality issues are detected through monitoring, there needs to be a process by which issues can be escalated to the appropriate level of management. This session will focus on:

  • Developing a process to escalate site compliance issues
  • Establishing a system to identify systemic trends
  • Integrating a site issue escalation into a robust CAPA process
  • Driving change within the organization through process improvement
  • Addressing the challenges: Culture, Systems, Workload & Resources
  • Demonstrating value to the trial teams and management

2:30 Transitioning from Auditing to a Quality Improvement System

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, Regulatory Support and Quality Assurance, University of Miami

The Office of Regulatory Support and Quality Assurance (RSQA) residing within the Office of Research, Miller School of Medicine at the University of Miami is on its way to advance from a well-established auditing program into a quality improvement program to provide support and assistance to the University research community. In the restructuring process, special attention will be paid to create a robust firewall between QA and QC activities. Quality Management approaches, in particular in respect to customer service, will be put into practice throughout the entire process of implementation.

3:15 Sponsored Presentation (Opportunity Available)

3:30 Refreshment Break

3:50 Good Clinical Practice, Six Sigma, and Lean Methodologies: New Friends on the Playground!

Barbara Osinski, Associate Director, QC GCP Compliance and Training, Clinical Development, Grunenthal USA, Inc.

Lean Sigma are the new “buzz words” being used when discussing Quality Risk Management. But what is it? How can a methodology which originated with manufacturing be applied to the world of clinical? How can an organization introduce a “lean mentality” without compromising quality? Do the regulations allow for this type of paradigm shift? Join us as we discuss a brief history of Lean and Six Sigma, how the methodologies are being applied to Good Clinical Practice and Quality Risk Management, and how it IS possible for everyone to “play nice in the sandbox”!

4:35 Effective CAPAs for Clinical Sites and Sponsors

Jeanne Morris BS, MT (ASCP), President and Principle Consultant, J2 Quality Consulting, former FDA Investigator

A fundamental element of a robust Quality System is the ability to identify and manage problems to prevent future risk. In this session, learn to effectively develop and implement Corrective and Preventative Action Plans at the clinical site, sponsor, and CRO location. The presentation will address CAPA responsibilities, plan components, and examples of how CAPA programs can reduce risk. As a former FDA Investigator, your speaker will highlight FDA’s expectations for CAPA and how the FDA field investigator reviews CAPA documentation to assess compliance.

5:20 Implementation of Quality Risk Management Systems to Manage Risks and Foster GCP Compliance in Global Clinical Trials

Nikita Somani, BPharm, M.Sc., Regulatory Manager, TIMI Study Group, Brigham and Women’s Hospital

As per the inspections performed by the FDA Office of Scientific Investigations (OSI) in 2010-2011, approximately 4% of the investigators were recommended with rejection of data due to data integrity and GCP non-compliance issues. Such GCP noncompliance issues have been bypassed due to lack of cost-effective and robust quality systems to produce reliable clinical data. Therefore a fundamental shift from traditional approach to risk- based approach is recommended in how the research is conducted and regulated. The risk-based strategy will target the resources more effectively to those activities that may be imposing greater risks.

6:05 Welcome Reception (Sponsorship Opportunity Available)

7:00 Close of Day One

Day 1 | Day 2