Clinical Trial Oversight Summit
2013 Archived Content

Second Annual | June 3 - 4, 2013
Vendor Management in Clinical Trials

Ensuring Quality through Effective Assessment, Qualification, Auditing, and Communication

Strategies and tools for assessing, implementing and improving quality when partnering with clinical service providers will be the focus of the second annual Vendor Management in Clinical Trials conference. With growing regulatory expectations for a quality systems-based approach to GCP compliance, sponsors must be certain that their third party vendor partners are “inspection ready.” Thought leaders will present their compliance-focused vendor management strategies, from selection through contracting and oversight. With domestic and international regulatory inspection trends in mind, speakers will guide attendees in implementing their own vendor qualification and management strategies. Risk-based approaches to vendor management will be addressed, as well as auditing of clinical service providers. Attendees can expect case studies, take-away tools, perspectives on the current regulatory environment, breakout groups and interactive activities.

Day 1 | Day 2 | Download Brochure 

Monday, June 3, 2013

7:00am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks


RISK-BASED VENDOR MANAGEMENT STRATEGIES 

8:15 Applying Risk-Based Approaches to Vendor Management & Vendor Oversight

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

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

As the sponsor of a clinical trial you are accountable for your service providers. Therefore, appropriate oversight is required. But this is easier said than done. What is deemed “appropriate”? How do I determine the “appropriateness” of oversight? And last but not least, what is the right model for outsourcing? In this session we will answer these questions and provide attendees with methodologies to help in making the right decision.

9:00 Partnering for Clinical Trial Success

Eric Forsthoffer, Strategic Relationship Director, Business Development, BioClinica, Inc.

It takes too long to start up studies and too long to close them out and get analyzable data. Through sound vendor management practices, including governance and key performance indicators, organizations are able to achieve success far ahead of expectations. Effective vendor management starts with each party viewing each other as a partner. Which skills each brings to the table and how they can effectively harness each other’s strengths will be emphasized in this session.

9:45 Networking Coffee Break and Exhibit Viewing

10:15 Impact of Biopharmaceutical Compliance Requirements: Art of Securing Sarbanes-Oxley (SOX) Compliant and Competitive Contractual and Budget Terms

Sally Teeters, CCRP, Senior Director, Legal and Business Management, CardioVascular BioTherapeutics, Inc.

The presentation will include 1) a brief overview of Sarbanes-Oxley (SOX) with emphasis of compliance challenges and impact on sponsors and CROs; 2) RFP process and strategy with emphasis on the importance of planning, evaluation, award process; 3) an in-depth discussion of the critical and non-critical contract; 3) key factors to consider when determining budget terms and type of payment terms; 4) the best practice of minimizing expense and processing of change orders; and 5) overview of good contract practices.

11:00 Interactive Roundtable Discussions

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


VENDOR QUALIFICATION AND CONTRACTING 

1:00pm A Comprehensive Approach to Qualification of Third Party Providers

Kimberly Washburn, Director, Quality Assurance, Global QA, Quintiles

The quest to develop a holistic approach to the identification, assessment, selection, contracting, and management of vendors is essential as a defensible positioning model to address regulatory and cost/oversight concerns with regards to third party vendor use. The facilitation of a standardized approach to vendor oversight lends itself to a consistent assessment model which is based on defined criteria. A risk-based approach with a defined underlining algorithm permits an organization the ability to apply a standard qualification approach for assessing all vendors, from an initial determination of inclusion/exclusion with the program, to the quality assessment method.


CASE STUDY 

1:45 The Contracting Process: Defining the Scope of Work, and Building Quality and Accountability into the Contract

Joe Popowicz, Director, Clinical Operations, Stryker Orthobiologics

Derek Gamber, Regional Sales Manager, MedNet Solutions

Strategic partnerships and functional service provider relationships have helped drive cost and time savings into the clinical development process for large pharmaceutical and medical device companies. This session will review a case study of a medical device company that developed a strategic partnership with an Electronic Data Capture (EDC) supplier. Best practices for vendor selection and contracting will be discussed including:

  • Tools to ensure a uniform assessment of capabilities, costs and timelines
  • Processes to ensure strategic fit for both parties
  • Defining roles and responsibilities as a key component to measure and ensure mutual success

2:30 Diagnostic Trials: A Process for CRO Selection, Qualification and Successful Oversight

Dayna Geralts, Manager, Clinical Affairs, Molecular Diagnostics, Hologic, Inc.

The responsibility of proper diagnostic clinical trial execution is not allowed to be delegated to a CRO per FDA regulations. Therefore, adequate qualification and oversight of CROs executing clinical trials for diagnostic sponsors is critical to a successful study and product approval. This presentation will review a detailed process from identification of CROs to study close out to ensure your study is executed appropriately.

3:15 Sponsored Presentation (Opportunity Available)

3:30 Networking Refreshment Break and Exhibit Viewing


CRO QUALIFICATION, SELECTION AND OVERSIGHT 

3:50 Adapting Outdated CRO Selection Models to Prevail in Extremely Competitive Study Conditions

Pierre Corin, Senior Director, Development Operations, Clinical, Cerexa

The usual model for vendor selection used by the industry is not producing the needed results. CROs constantly rank low on the quality surveys published by the pharmaceutical industry, despite the fact that several of them continue to grow and develop. This presentation will address the need for a more precise and rigorous vendor selection that match the sponsor request more appropriately.


CASE STUDY 

4:35 Leveraging the Sponsor-CRO Relationship for Study Success

Christine E. Buben, MS, MBA, Director, Clinical Operations, Tarsa Therapeutics, Inc.

Rebecca Cope, PMP, Product Manager, BioClinica, Inc.

The partnership between a sponsor and an imaging CRO is a critical one to ensure study success in clinical trials that rely on imaging for efficacy data. The objectives of this presentation are to:

  • Explore unique features that should be considered during imaging vendor selection
  • Review operational tactics that promote quality within the CRO team and at clinical sites
  • Examine strategies for effective partnership to achieve study milestones
  • Present a case study in which Tarsa Therapeutics partnered with BioClinica for a successful pivotal osteoporosis trial

5:20 Reception and Exhibit Viewing (Sponsorship Opportunity Available)

5:45 Short Course Registration

6:00 - 8:30 Dinner Short Course 1, Project Management of CROs 

6:20 Close of Day One



Day 1 | Day 2 | Download Brochure