2015 Archived Content

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Clinical trial outsourcing has become a focal point for the Clinical Project Manager. For those managing these trials, it is imperative to know how to improve study outcomes, maximize efficiency, and apply risk-based best practices, techniques, and tools to the outsourced relationship. This forum will address the specific challenges, needs, and opportunities in outsourced clinical trials, where thought-leaders will share their experiences, best practices, and case studies.

Tuesday, June 2

12:00 pm Conference Registration

1:20 Welcome & Chairperson’s Opening Remarks

1:30 Clinical Trial Vendor Oversight: The CRO Strategic Partner

Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC)

Outsourcing clinical trials is a rapidly growing trend, affecting all professionals at all levels of clinical research. This session begins with insights into how sponsor companies should approach the selection of CRO strategic partners, and continues into how to manage the ongoing relationship while providing adequate oversight. Your presenter will share real-world techniques for implementing best practices and avoiding pitfalls in the outsourced clinical trial model.

2:15 Using Risk-Based Management to Improve the Quality of Your Clinical Trials

Michael Howley PA-C, Ph.D., Physician Assistant – Certified Faculty Coordinator, MBA Healthcare Concentration, Associate Clinical Professor, Department of Marketing, LeBow College of Business, Drexel University

Typical risk-based management techniques usually involve enhanced auditing approaches to identify quality problems after they occur. In this session, your presenter will show you how you can use risk-based quality metrics to identify and correct quality issues before they become problems.

2:30 Sponsored Presentation (Opportunity Available)

3:00 Networking Refreshment Break and Exhibit Viewing

3:30 Case Study: Using Analytics and Visualization Tools to Identify and Evaluate Risk and Support Decision-Making

Rosanne Petros, PMP, Associate Director, Clinical Research, Clinical Research Manager US Global Clinical Trial Operations, The Americas, Merck Research Laboratories

Merck has developed and utilizes metrics reports which allow coarse or finer granularity of focus to identify risk within clinical trials and support decision making regarding study course. Based on robust and accurate underlying data, reports can be run and distributed to the upper and middle study management tiers down to the site management level. The majority of data used to support these reports is obtained from Merck’s CTMS (Clinical Trial Management System) and supplemented from data from EDC, IVRS, and study-specific data repositories. Reports and graphs show study milestone, enrollment metrics, protocol deviations, action items, subject tracking and SDV, data metrics, and monitoring visit data. Data “cuts” and associated visualization can be at the therapeutic area, region, country, study, or site levels to provide objective risk evaluation within the confines of a therapy area, program, region, country, study, or individual site or institution.

4:05 Implementing Risk-Based Monitoring – It Is Not Rocket Science!

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

Many sponsors have embarked on the new course of risk-based study management and risk-based monitoring, but many are struggling to complete the change. There are some essential questions that need to be answered:

• What is the reason for the difficulties that sponsors face when implementing a risk-based approach to monitoring?

• How can we overcome these difficulties? What are the key elements that need to be considered?

• How come most of the sponsors cannot realize the cost saving potential that risk-based monitoring promises? What needs to be done to make it happen?

• With monitoring focused where it really matters, how can we detect real quality improvements?

This presentation will address the most appropriate approach to a risk-based monitoring concept and its components, and will give answers to the most intriguing questions on how to establish a risk-based monitoring approach in your company.

4:40 Case Study: Can Big Data Help in Detecting and – Even More Importantly – Preventing Fraud in Clinical Trials?

Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis

Both patients and investigators can commit fraud for different reasons. For investigators, fraud is often viewed as fabricating, manipulating, or deleting data; whereas for patients, fraud is most likely enrolling at two or more clinical trials sites for a variety of reasons. Despite the many available statistical tools, fraud is very difficult to detect. One method is to use the lab data and to compare patients amongst each other to look for similarity. This way, quite early, we can diagnose some signals that could indicate a potential cause of fraud. Using TAPAS, our risk assessment tool, we run this data weekly across all studies and at all sites, giving us a possibility to see such cases.

5:15 Reception and Exhibit Viewing

(Sponsorship Opportunity Available)

5:45 Short Course Registration

6:00 Close of Day One

6:00 - 8:30 pm DINNER SHORT COURSE:
(SC2) Quality by Design in Clinical Research: Is This Only for the Protocol?*

* Separate registration is required. 

Wednesday, June 3

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:15 Chairperson’s Opening Remarks


8:25 Cyber-Connectedness with Your CRO: Compliance and Peace of Mind

Mollie Shields-Uehling, President and CEO, SAFE-BioPharma Association

Betsy Fallen, Global Head of Program and Business Development, SAFE-BioPharma Association

Cyber-connectedness in outsourced trials is more important now than ever before. Companies need to know, with certainty, that they can trust the identities of individuals on the other side of electronic transactions who are allowed access to valuable trial-related information assets and who are eSigning electronic documents. Created by the biopharmaceutical industry, FDA, and EMA, SAFE-BioPharma is the industry standard for identity management and for applying digital signatures to electronic documents. Beyond business peace of mind, this is an issue of regulatory compliance, including the upcoming EMA eSubmissions digital signature requirements. The company developing the TransCelerate Shared Investigator Platform portal is adopting the SAFE-BioPharma standard, as has the company to which it has outsourced development of its identity management component. Your speakers will provide multiple perspectives, including SAFE-BioPharma leadership, an experienced expert responsible for guiding use of technology in drug development, and a representative to discuss the use of the standard in clinical development.

9:00 Case Study: Applying Strategies to Successfully Operationalize Atypical Studies of Rare Diseases Through a Successful Global Partnership

Patricia Nowowieski, Head, Global Clinical Operations, Cambridge, Global Clinical Operations, Alexion Pharmaceuticals

Donna Holloway, Director, Clinical Project Management, Quintiles

In order to bring medicines to patients with devastating ultra-rare diseases, traditional study designs for large, randomized trials need to be reconsidered. Using the four phases of study execution: planning, initiation, conduct and close-out, we will discuss the benefits of a nimble and flexible partnership to address the complexities of ultra-rare diseases and the necessity to tailor high-impact solutions to trial operations. Attendees will improve their understanding of how to:

• Operationalize atypical studies of rare diseases, in which every data point matters

• Identify factors leading to a successful global collaboration, allowing rapid mobilization in countries/regions at the time a subject is identified

9:20 Sponsored Presentation (Opportunity Available)

9:35 Networking Coffee Break and Exhibit Viewing

10:20 Case Study: Adaptive Monitoring: How to Manage Sites Without Visiting Them

Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis

Adaptive Monitoring uses real-time performance metrics to oversee sites on a daily basis, and permits us to focus attention on the areas that need it the most. Using our TAPAS tool, the central analytic function team and the central monitoring team have access to reports that enable them to focus their work based on continuously tracked site performance metrics. This means that problem sites receive earlier and more frequent visits, while sites showing no major difficulties receive fewer visits at much greater intervals, as long as they continue to maintain a timely flow of high-quality data and show satisfactory performance on study activities. Combined with remote monitoring, adaptive monitoring allows better allocation of resources and definitively helps sponsors to dramatically boost efficiency, increase quality, and reduce risk, without collecting less data. Ultimately, Adaptive Monitoring reduces site visits and cut some costs, without sacrificing data quality or safety.

11:00 Interactive Roundtable Discussions

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 pm Building a Global System: Promoting Accountable Research

Greg Koski, Ph.D., M.D., Co-Founder & President, ACRES; former Director, Office for Human Research Protections, U.S. Department of Health and Human Services

ACRES, a non-profit multi-sector stakeholder collaborative working in the public interest, is a one-of-a-kind, innovative initiative building an open, integrated global system for clinical research. Adapting lessons from other industries that have successfully implemented principles of systems and safety engineering, such as transportation, communications, and information technology, ACRES is applying these principles to the clinical research process to build a true system that will increase safety, efficiency, and professionalism of the endeavor globally, benefiting all stakeholders, especially patients. ACRES believes that disruption alone is insufficient – our goals must be constructive – building the future together, for the benefit of all. This session will highlight and discuss the Alliance’s current initiatives, progress, and expectations.


1:50 Risk-Based Approached to Outsourced Relationships: Best Practices, Tools, and Techniques

Lynnette Wright, Global Contracts & Outsourcing Lead (GCOL), Astellas Pharma Global Development, Inc.

As the pharma industry is shifting its traditional outsourcing model where the sponsor develops a long-term relationship with suppliers, the sponsor needs to evaluate the benefits and risks of the best approach for outsourcing. Appropriate controls need to be in place to reduce business risks and to comply with the requirements of FDA for the vendor oversight by the sponsor. During this session, your speaker will share some of the best practices to manage the risks of outsourcing and to ensure regulatory compliance. What if you knew the outsourcing risks and how to avoid the pitfalls of sourcing? What are the best practices to manage sponsor/supplier relationship? The objective of this session is to:

• Better understand the risks sponsors face with outsourced relationships

• Explore best practices to mitigate risk and implement controls to handle identified risks

2:10 Sponsored Presentation (Opportunity Available)

2:25 Networking Refreshment Break

2:40 Case Study: Predictive Modeling to Optimize Enrollment Outcomes in Outsourced Phase III Studies: A Case Study

Moe Alsumidaie, MBA, MSF, Chief Data Scientist, Annex Clinical

Predicting and changing future outcomes has always been a concept of the past, until today. Enrollment performance continues to be a key challenge and resource intensive component of conducting Phase III research in outsourced studies. During this session, hear how a clinical operations team was able to precisely forecast trial completion dates as early as 30% in trial enrollment, predict and react to future operational outcomes, and implement breakthrough business research tools to uncover enrollment performance issues. Understand the analytical strategies that were executed to:

• Precisely forecast, predict and benchmark trial completion date ranges

• Foresee slowdowns and upturns in enrollment momentum

• Uncover performance issues

• Improve future enrollment outcomes

3:15 Integrated Quality Oversight in Clinical Trials

Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium

To ensure patients in high medical need continue to have access to affordable drugs, companies and authorities are looking at means to decrease the cost of clinical trials while still maintaining oversight on patient safety and integrity, and data credibility. A risk-based approach has been encouraged by both EMA and FDA as a mean to deploy resources where it matters most based on identified risks. Pharmaceutical companies need to control risks related to patient safety, protocol non-compliance, budget (over)spending, trial timelines, etc. This presentation addresses an integrated risk-management approach towards oversight in clinical trials, following some of the key CTTI principles: starting off with the clinical team from an integrated risk assessment of the trial, de-risk the protocol and implement controls to mitigate the identified risks, and manage the residual risks through an integrated quality plan.

3:50 pm Close of Summit

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