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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.” Barnett International and Cambridge Healthtech Institute’s Inaugural Vendor Management in Clinical Trials conference will feature strategies and tools for assessing, implementing, and improving quality when partnering with clinical service providers. Speakers will share their experiences in vendor selection and contracting, defining and implementing quality metrics with their vendor partners, and auditing clinical service providers with current regulatory inspection trends in mind. Presentations will feature case studies, take-away tools, perspectives on the current regulatory environment, and interactive activities.
Attend the EVENT Short Course*
Wednesday, June 6, 2012 8:30 AM - 11:00 AM
Proactive Approaches to Vendor Management
Instructors:
Michael J. Harte, Founder and President, The Harte Group
James Kirwin, Vice President and Senior Advisor, Clinical
Development Operations, The Harte Group
* Separate registration required.
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Wednesday, June 6, 2012
8:00 am Event Short Course Registration and Morning Coffee
11:00 Main Conference Registration
12:45 pm Barnett Welcome & Chairperson’s Opening Remarks
1:00 Implementing a Quality Management Approach to Clinical Vendor Selection
Susan Lubin, Associate Director, Outsourcing; Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb Co.
Kristian Hubbard, Manager, Outsourcing; Discovery Medicine Clinical Pharmacology, Bristol-Myers Squibb Co.
1:45 Clinical Trial Success Begins with the Scope of Work: How to Ensure Your Trial is Successful Using the Task Order Agreement
Manley Finch, Executive Director, HIV Nutrition Network, NPO
Clinical trials are often derailed by a fundamental lack of clarity in the scope of work between the sponsor and CRO or other vendors. The devil is in the details. A strong starting point is a detailed Task Order Agreement that clearly outlines the scope of work, the timelines, and responsible parties. Cost overruns, delays, and damaged sponsor/vendor relationships create havoc in clinical development programs, and create a tremendous fiscal and resource burden to the industry. Effective vendor outsourcing depends on clearly defined goals, expectations, and responsibilities.
2:30 Building Quality and Accountability into Vendor Contracts
Sally Teeters, Senior Director, Legal and Business Management, CardioVascular BioTherapeutics, Inc.
The presentation will include: 1) A brief overview of SOX with emphasis of the challenges and impact is has on sponsors and CROs; 2) The importance of planning and processing of RFPs; 3) An in-depth discussion of the critical contract terms, as well as the other contract terms which tend to be considered non-critical but may have a major impact; 4) Key factors to consider when determining budget terms; 5) The best practice of minimizing expense and processing of change orders by specifying the format, timing and approval process; and 6) Identification of good contract practices.
3:15 Refreshment Break
3:45 Haunted by the Contract: How Upfront Mistakes Lead to a Host of Nightmares
Charles Wienbar, Program Manager, Participant Recruitment, Clinical and Translational Science Institute, University of California, San Francisco
This session features a case study of how a poorly written $3 million vendor contract put a $150 million acquisition at risk. The pivotal study was in rescue mode due to a number of compliance issues. The vendor was tasked with auditing ~20 international sites and documenting the corrections. The structure of the agreement was such that the vendor was paid for site monitoring visits, when it was the filing of visit reports that mattered to the company, the FDA, and the acquiring entity. It is a common problem that the payment structure in a contract is not tied to clinically meaningful deliverables. As a result, the incentives of the vendor do not support the strategic objectives of the sponsor. Attendees will gain an appreciation of how a poorly structured contract creates downstream problems at the sites and with data collection, and how a well-written contract can help steer a vendor in the right direction.
4:30 Applying Vendor Management Practices to Clinical Research Sites
Glenda Guest, Vice President, Norwich Clinical Research Associates (NCRA)
You manage the vendors who supply you with materials to manufacture your product, why not apply those vendor management concepts to management of research sites? This presentation is designed to help participants see the parallels between vendor management activities in the manufacturing setting and how they can apply in a clinical research setting. The protocol, investigator agreements, qualification visits, and other activities already performed by the majority of individuals engaged in regulated research are related to manufacturing supplier contracts, vendor qualification audits, and other vendor management activities.
5:15 Welcome Reception (Sponsorship Opportunity Available)
Attend the Dinner Short Course*
Wednesday, June 6, 2012 6:00 PM - 8:30 PM
SOP Assessment: Ensuring GCP Compliance in Standard Operating Procedures (SOPs)
Instructor: Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management
* Separate registration required.
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