2016 Archived Content

Clinical Trial Auditing

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.


10:00 am Conference Registration

Quality Plans and Change Management
for RBM

10:40 Chairperson’s Remarks

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

10:45 Co-Presentation: ICH E.6 Addendum & Change Management towards a Metrics Based Future

Andy Lawton, Global Head, Data Management, Biometrics & Data Management, Boehringer Ingelheim Ltd.

Jean Baumann, Change Management Specialist, JMB Consulting, LLC

The forthcoming release of the addendum to ICH E.6 (GCP) will encapsulate risk-based methodology into the GCP framework; it will no longer be something to ignore as a fashion, but to use as a launch pad for innovation. The draft addendum will be reviewed and discussed, in particular the short and long term impact to organisations.

Of critical importance to the success of risk-based methodologies and the resulting metrics taking hold in an organization, is having a change management strategy that matches the organization’s starting point. Specific change management and project management methods will be introduced to optimally implement risk-based methodologies and innovations.

Remarque Systems12:15 pm How Signal-Driven SDV™ and Risk Based Monitoring Helps Improve Data Quality and Bring Efficiency to Clinical Trials

Badhri Srinivasan, President, Remarque Systems, Inc.

1:00 Dessert Break in the Exhibit Hall

1:30 Session Break


1:55 Chairperson’s Remarks

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

2:00 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

The field of clinical research is constantly evolving and CAPA (Corrective Action Preventive Action) is no longer exclusive to manufacturing and laboratory processes. The creation and implementation of corrective and preventive actions as well as fully executed CAPA plans is becoming a cornerstone of high quality clinical research programs. Although CAPA plans are not specifically mentioned in the regulations governing clinical research, FDA and other regulators as well as organizational leadership expect Principal Investigators, sponsors and IRBs to respond to compliance issues via such plans. Risk assessments and root-cause analyses, as well as short and long-term commitments to improve quality, will become a necessary part of a well-functioning research team. This presentation will provide the audience with examples of positive change, heightened awareness and strategies for the creation and implementation of a CAPA system in academia. Essential elements for a robust CAPA system, potential and existing barriers and the placement of CAPA within an organization’s quality program will be discussed. The take-home message is that a well-functioning CAPA system is becoming an essential element of any organization’s quality assurance program.

2:30 Building Quality Assurance (QA) and Quality Systems Management (QSM) into Clinical Research Operations

Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

3:30 Refreshment Break in the Exhibit Hall

Risk-Based Auditing

4:00 Moving Away from a “Conventional” Approach to Auditing in Clinical Trials

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

Recent and continuing changes to the regulatory environment – changes in regulation, increased complexity in clinical trials, new approaches to clinical trial conduct such as electronic data capture, electronic medical records and risk-based monitoring, impact the quality of clinical trials and the resulting data. The drive towards a risk-based approach to clinical trial conduct and oversight necessitates a change to clinical audit programs. A “conventional” approach to auditing clinical trials is no longer sufficient. This session will focus on methods and tools that can be considered in developing a clinical trial audit program that is designed for the 21st century, and assuring quality and compliance in today’s clinical environment.

4:30 Science-Based Auditing of Clinical Trials

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

Topics covered in this presentation include: 1. Traditional Audit Methodologies, 2. Science-Based Auditing, and 3. Lessons Learned.

5:00 Close of Day


8:30 am Interactive Breakout Discussion Groups with Continental Breakfast

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

Vendor Performance, Quality and Metrics

9:25 Chairperson’s Remarks

Jessica Dolfi, Manager, Solution Consulting, Medidata Solutions

9:30 Speed Networking

10:00 Partnering Quality with Our Quality Partners: Managing Clinical Trial Quality through Oversight and Collaboration with Our CRO Partners

Derek Hall, Associate Director, Quality Assurance GCP, Incyte

This presentation will cover: 1. Managing audits of vendors in a large global market, 2. Establishing quality contacts and regular communication, and 3. Writing and establishing a quality agreement.

10:30 Resource Planning, Real-Time Project Reporting and Dashboards

Donna Gandt, Area Vice President, Unanet

The presenter will demonstrate how customers utilize Unanet to facilitate Resource Scheduling & Skills Management; Time Tracking; Real-Time Reporting on Project Status, Margin, Utilization, etc.; Billing & Revenue Recognition; Integrated Financials.

10:45 Coffee Break in the Exhibit Hall

11:30 Issue Escalation for Fully Outsourced Studies

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

12:00 pm Vendor/Sponsor Performance Metrics: How Are We Doing?

Randy Krauss, Director, Clinical Process Optimization, Shire

Completing clinical trials in a timely, cost-effective, and safe manner is key to the success of both the vendor and sponsor. The number and types of metrics to be implemented can be dizzying. Understanding what is important to the sponsor will help determine what metrics are best to be implemented. Further, not all metrics are created equal. This talk will focus on developing a metrics hierarchy and how to use them to improve performance.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

1:55 Chairperson’s Remarks

Jessica Dolfi, Manager, Solution Consulting, Medidata Solutions

2:00 PANEL DISCUSSION: Project Tracking and Establishing Appropriate Metrics from Both the Sponsor & CRO Perspective

Randy Krauss, Director, Clinical Process Optimization, Shire

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

Marie Rosenfeld, Director, Development Operations, Contracts & Outsourcing Vendor Management Lead, Astellas Pharma Global Development, Inc.

From both the sponsor and CRO perspective, we will discuss what are considered the “right” metrics to collect on vendor performance and how well projects are being completed. Are there appropriate “hard” and “soft” metrics that should be considered when working with sponsors, CROs and other clinical vendors (labs, imaging centers, reading centers, etc.)?

3:30 Close of Conference

Pair this program with Mastering Risk-Based Monitoring and a Dinner Course on Expectations of Risk-Based Monitoring to maximize your time at the Clinical Trial Innovation Summit!

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