Clinical Trial Oversight Summit

Short Courses*


(Monday, June 2 6:00-8:30 pm)

(SC1) Best Practices to Becoming a Preferred Site

Janet Ellen Holwell, CCRC, CCRA, Clinical Research Consultant

Mirror, Mirror, on the wall, who’s the fairest site of them all? It could be you! This workshop will explore best practices for FDA-compliant source and regulatory documentation and the tools that can help to get you there. Join us to learn how to best prepare for a monitoring visit or site audit/inspection. Most non-compliance noted through monitor visits, regulatory inspections, and audits stem from inadequate and inconsistent documentation at sites. Learn techniques to better manage your regulatory files and prepare to answer sponsors, auditors, and inspectors regarding screening/enrollment numbers, subject withdrawal, informed consent, recruitment efforts, delegation of authority, protocol violations, and adverse events. Identify what is adequate source. What do I really need to file in my site master file? What are “extras” that will make my site preferred by sponsors? Tips and tricks for managing the regulatory file will be provided through tools, worksheets, templates, and interactive activities. Best practices for documentation and management of investigational product will be shared. Objectives include:

  • Identify the extra steps needed to take for unblinded components of trials
  • Recognize the importance of quality in clinical trials by identifying key areas for improved documentation and communication
  • Identify key areas for improved documentation and communication leading to better quality
  • Manage documentation of recruitment efforts effectively


(Tuesday, June 3 1:00-3:30 pm)

(SC2) Metrics & KRIs: Study Oversight in a Risk Management Environment – How to Make It Work!

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

Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC

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 FDA and EMA guidances, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics 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 is designed to provide its participants with a strong conceptual foundation for defining and developing meaningful Quality Risk Indicators and Critical to Quality metrics along with corresponding thresholds for acceptability of outcomes that can be used across clinical trial processes.


(Tuesday, June 3 6:00-8:30 pm)

(SC3) Managing the CRO Relationship: From Engagement through Delivery

Michael J. Harte, Founder & President, The Harte Group

In this workshop, we will explore effective and creative approaches to the Sponsor/CRO relationship, from engagement through delivery. Participants will learn to:

  • Ensure the validity and accuracy of their program: Validate the protocol and assess patient availability and compliance
  • Start with the end in mind: Regulatory expectations; data presentation; and study goals
  • Consider key points in CRO engagement: CRO pricing; development activity and objectives; the use of electronic systems; vendor workflow and process; taking steps to engage QA support to maintain audit-readiness of your program; encourage input from CRO functional groups for better, creative, and more efficient ways to conduct the program
  • Identify ways that the CRO can be held accountable for their deliverables: Deliverable-based vs. time-based contracts; if wrong selection of CRO made, never fear changing
  • Ensure total transparency of all parties/functions: Better communication ensures that everyone aware of status and need for their services


(Wednesday, June 4 6:00-8:30 pm)

(SC4) Take Control of Your RCA and CAPA Activities to Achieve Clinical Excellence

Eric Morfin, MBA, PMP, Partner, Clinical Excellence Research Institute; Partner, Critical Skills, Inc.

In 2011 and 2012, 47% and 43% respectively of the FDA audit findings were related to Corrective Action/Preventive Action. The findings identified a lack of systematic root cause analysis. Attend this hands-on workshop to:

  • Streamline your clinical operations timelines by quickly identifying the root cause of any deviation and getting the project back on schedule
  • Minimize your audit risks by establishing a reliable CAPA process demonstrating a systematic, step-by-step Root Cause Analysis and Corrective Action Process
  • Integrate your CAPA processes with other Continuous Improvements Tools such as Six Sigma
  • Analyze real-life RCA/CAPA case studies in small groups and individually


(Thursday, June 5 1:00-3:30 pm)

(SC5) Quality by Design for Success: QbD in the Design and Planning of Your Clinical Trial

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

Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC

Regulators are demanding a risk-based approach to managing quality in clinical trials and in particular monitoring as an oversight tool. Many have started to work on such an approach, however, they fail to be successful. The main reason for this failure is found in ignoring the Quality by Design (QbD) aspect of clinical trials in the first place. We have all seen studies with many protocol amendments that were necessary even before the trial started. This is only one example of wasting time and money, including extending the timelines of clinical studies unnecessarily. If you are not building your risk-based monitoring methodology on a sound foundation of a well-designed trial, even the smartest set up of risk-based monitoring will not live up to its expectations. In this workshop, you will learn what aspects to consider when designing a clinical protocol, when you plan for the study start up based on the approved protocol, and when you plan to use metrics to measure adherence to the protocol and support risk-based monitoring.

*Separate Registration Required