Maximizing Sponsor-CRO Partnerships

• Managing Risk When Contracting With Service Providers •
• Achieving Cohesive Working Relationships in an Atmosphere of Increased Scrutiny •

Thursday, June 14, 2007

About

So much can go wrong when partnering with CROs,...
The future of a company can depend on the outcome of a clinical trial...

Growing public scrutiny and clamor over the practices of clinical trial sponsors, as well as the increasing expense of product development, have caused pharmaceutical, medical device, and biotech companies to increasingly outsource their clinical trial activities to CROs.

Such outsourcing, however, creates a potential minefield of risks. In selection and qualification, the sponsor runs the risk that the CRO does not have the resources or expertise to conduct compliant trial-related duties, and the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. In contract detail, trial-related duties transferred to a CRO must be identified clearly. Yet given the exigencies of service agreements, including turnover in leadership and bridging learning curves of new clinical trial managers, this is no easy task. In oversight, failure to implement checks and balances to monitor duties can cause the trial, budget, or even compliance to go way off course. If all this were not enough, recent EMEA and FDA publications and the establishment and management of independent DSMBs have created formidable challenges in ensuring clear assignment of responsibility between sponsors and CROs.

The time is now for you to minimize the risks. This unique event will help you use service agreements to your company’s advantage and create positive and efficient relationships with CROs.

There is one place that industry professionals with a stake in clinical development partnerships can come to resolve the dilemmas and problems associated with sponsor-CRO partnerships. American Conference Institute’s timely publication from the forum on Maximizing Sponsor-CRO Partnerships will explore how service agreements can be drafted to anticipate and prevent every imaginable contingency given the volatile nature of the drug development arena. Through a faculty of experts skilled in executing “win-win” relationships between sponsors and CROs, this conference also will address the collaborative skills needed to ensure that trials in emerging countries are conducted within the labyrinth of guidelines, identify models for the management of outsourced relationships, and discuss how to effectively utilize performance metrics to assess partnerships.

Contents & Contributors

About

So much can go wrong when partnering with CROs,...
The future of a company can depend on the outcome of a clinical trial...

Growing public scrutiny and clamor over the practices of clinical trial sponsors, as well as the increasing expense of product development, have caused pharmaceutical, medical device, and biotech companies to increasingly outsource their clinical trial activities to CROs.

Such outsourcing, however, creates a potential minefield of risks. In selection and qualification, the sponsor runs the risk that the CRO does not have the resources or expertise to conduct compliant trial-related duties, and the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. In contract detail, trial-related duties transferred to a CRO must be identified clearly. Yet given the exigencies of service agreements, including turnover in leadership and bridging learning curves of new clinical trial managers, this is no easy task. In oversight, failure to implement checks and balances to monitor duties can cause the trial, budget, or even compliance to go way off course. If all this were not enough, recent EMEA and FDA publications and the establishment and management of independent DSMBs have created formidable challenges in ensuring clear assignment of responsibility between sponsors and CROs.

The time is now for you to minimize the risks. This unique event will help you use service agreements to your company’s advantage and create positive and efficient relationships with CROs.

There is one place that industry professionals with a stake in clinical development partnerships can come to resolve the dilemmas and problems associated with sponsor-CRO partnerships. American Conference Institute’s timely publication from the forum on Maximizing Sponsor-CRO Partnerships will explore how service agreements can be drafted to anticipate and prevent every imaginable contingency given the volatile nature of the drug development arena. Through a faculty of experts skilled in executing “win-win” relationships between sponsors and CROs, this conference also will address the collaborative skills needed to ensure that trials in emerging countries are conducted within the labyrinth of guidelines, identify models for the management of outsourced relationships, and discuss how to effectively utilize performance metrics to assess partnerships.

Contents & Contributors

SPONSOR – CRO PARTNERSHIPS INTERNATIONALLY: OVERCOMING ISSUES WHEN CONTRACTING GLOBALLY
Maria D. Buckley, Nutter McClennen & Fish LLP (Boston, MA)

NEGOTIATING AND LIMITING LIABILITIES AND INDEMNIFICATION BETWEEN THE PARTIES
James Lovett, Covance, Inc. (Princeton, NJ)

NEGOTIATING AND LIMITING LIABILITIES AND INDEMNIFICATION BETWEEN THE PARTIES
Natasha Leskovsek, Heller Ehrman LLP (Washington, DC)

NEGOTIATING AND LIMITING LIABILITIES AND INDEMNIFICATION BETWEEN THE PARTIES
Tanya Dobash Berlage, Saul Ewing LLP (Baltimore, MD)

ANALYZING PROJECT MANAGEMENT AND STAFFING APPROACHES
Kathleen McCarthy-Kirby, Clinical Operations Consultant (Boston, MA)
Linda D. Bentley, Mintz Levin Cohn Ferris Glovsky and Popeo P.C. (Boston, MA)

TIMELINES: MANAGING PROMISES AND EXPECTATIONS
C. Lee Jones, Essential Group Inc. (Gurnee, IL)

MAXIMIZING DEVELOPMENT: EVOLVING MODELS OF OUTSOURCING AND THE IMPACT OF OUTSOURCING ON BIOMEDICAL PRODUCT DEVELOPMENT
Douglas Peddicord, PhD., Association of Clinical Research Organizations (ACRO)

THE VALUE PROPOSITION OF WORKING WITH CROS: COMPENSATION, PRICING, PAYMENT TIMELINES, AND BEYOND
Deborah Turunjian, OSI Pharmaceuticals, Inc. (Boulder, CO)
Alison Macpherson, Bright Pharmaceutical Services (Sherman Oaks, CA)
Charlene Dark, Data Management, SDC, Inc. (Raleigh, NC)

AVOIDING CONFLICTS RELATING TO CONFIDENTIALITY, DATA PROTECTION, AND OWNERSHIP OR SHARING OF IP
Decanda M. Faulk, RN, Esq., CHC, Carella, Byrne, Bain, Gilfillan, Cecchi, Stewart & Olstein, P.C. (Roseland, NJ)

AVOIDING CONFLICTS RELATING TO CONFIDENTIALITY, DATA PROTECTION, AND OWNERSHIP OR SHARING OF IP
Rachel Abramovitz, Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY)

ASSESSING CRO QUALIFICATIONS AND SELECTING THE RIGHT CRO
Candace Lee, RN, BS, CCRC, Eurand Inc.; Greater Columbus Chapter (Vandalia, OH)
Nadina C. Jose, MD, CPI, MBA, Research Strategies Inc. (Arcadia, CA)
Michael Rogovin, BS, JD, Wyeth Research (Collegeville, PA)

SPONSOR-CRO PARTNERSHIPS INTERNATIONALLY: OVERCOMING ISSUES RAISED WHEN CONTRACTING GLOBALLY
Lisa K. Brown, Shire Human Genetic Therapies, Inc. (Cambridge, MA)

DATA SAFETY MONITORING BOARDS, CROS AND SPONSORS
Victoria Colasanto, Averion International Corp. (Southborough, MA)

THE BEST LAID COMMUNICATION PLANS: ESTABLISHING BETTER LINES OF COMMUNICATION AND MAINTAINING THEM
Donna Saligan, MBA, MT (ASCP), RH Bouchard & Associates, Inc. (Tiverton, RI)
Susan Morris, M.Ed, CPCC, ACC, Morris Consulting Group LLC (Longhorne, PA)

OPTIMIZING CRO RELATIONSHIPS THROUGH PERFORMANCE METRICS THAT ARE ALIGNED WITH CORPORATE GOALS
James B. Jones, MD, PharmaD, FACEP, Alpharma Pharmaceuticals (Piscataway, NJ)
Robyn Philip-Norton, OSI Pharmaceuticals, Inc. (Oncology) (Melville, NY)
Patricia Devitt Risse, PharmaD, Advanced Clinical Trial Solutions, LLC (Flemington, NJ)

WEIGHING TACTICAL V. STRATEGIC AS YOU OUTSOURCE OPERATIONS TO CRO
Maria Acgaoili, Contracts & Outsourcing, Pfizer Inc. (New York, NY)
Jan A. de Witt, MD, The Partnering Group of Quintiles Transnational (Netherlands)



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