"A Practical Approach to Achieving Success
With CROs and Other Outsourcing Providers"

Developed by
John R. Vogel, Ph.D.

"Each time John presents his outsourcing workshop to the Roche Bioscience teams I come out looking good. He covers the practical aspects of contract research and speaks to everyday needs of project team members. We always learn something new that we can immediately apply to solving real outsourcing issues."

Sue A. Stempien
Director, Outsourcing Management
Roche Bioscience

"John Vogel's workshops were well received and achieved high marks from members of the department of Clinical Investigations, Roche Laboratories. The course provided valuable information and education on not only the day-to-day management of outsourced projects, but also for what we believe to be the most critical piece of outsourcing, effective planning. Dr. Vogel's interactive and lively presentation format invites participants to actively participate in all discussions. This, along with his extensive knowledge of the subject, leaves the participants with useful and practical information that can be applied daily to work more efficiently and effectively with CROs."

Diane Polito, M.S., Team Leader
Clinical Affairs Contracts Office
Roche Laboratories, Inc.

Introduction

The role of outsourcing is increasing as companies attempt to accelerate drug development in an environment often characterized by cost-cutting measures. Increased emphasis on using contractors has shifted the role of in-house staff from performing study-related tasks to managing complex service relationships. Technically competent personnel may, nevertheless, lack the skills and experience to work effectively with CROs and other outsourcing providers.

This 1½-day training program is designed to provide personnel with the necessary skills to select and manage CROs and other outsourcing providers in an efficient and cost-effective manner.

Objectives

• Convey a practical understanding of the steps and processes necessary for building partnerships with CROs and other outsourcing providers.
• Provide useful forms and checklists.
• Describe positive examples of successful outsourcing.
• Create a highly participative environment in which people learn by performing tasks.
• Give participants an opportunity to find solutions to current outsourcing problems they are facing.
• Ensure that participants take away real, practical skills that can be used in the workplace.

How can the program be customized for you?

• Emphasize topics selected by you. If the participants are experienced in one or more specific areas, a brief overview (approximately 15 minutes) rather than a detailed discussion of the topic(s) can be presented.
• Involve you in selecting among role-plays for the problem-solving exercises. Training participants perform two exercises on problem-solving techniques. A series of eight scenarios are available from which you can choose the two that you believe will best relate to the interests of the group (e.g., clinical research, data management, project management).
• Integrate your SOPs and guidelines. The sourcebook is a 1½-inch, 3-ring binder with approximately 200 pages of tables and text. You may wish to insert copies of guidelines and formats used at your company. Sourcebook forms are used for teaching purposes. However, the specific procedure to be used at your company can be presented as well.
• Include presentations by your contract administration department. Participation by your department in presenting training materials will increase awareness that a central contracting resource is available to assist teams with their outsourcing needs.

How will personnel benefit from this training?

Designed on the principle that people learn best by actually doing, this workshop stresses group exercises and discussions to ensure that participants gain practical, "hands on" experience using proven techniques for managing outsourced projects. Participants receive a 200-page "sourcebook" which is designed to serve as a future reference.

At the end of the training program your staff will have learned how to:

• Decide when to outsource services
• Decide among outsourcing alternatives
• Identify study specifications
• Assess a CRO’s capability, compatibility and cost
• Ensure that the sponsor and CRO have realistic, mutual expectations and shared goals
• Utilize performance metrics to ensure that objectives are achieved
• Manage the sponsor-provider relationship
• Recognize problems at an early stage
• Solve problems encountered with sponsor-provider relationships

Who should attend?

• Clinical Research
• Biostatistics
• Data Management
• Contract Administration
• Medical Affairs
• Project Management
• Marketing Support
• OTC

Training Program

Day One

Introduction

• Group discussion: Workshop expectations
• Frequent causes of outsourcing problems
• Workshop goal and objectives
• CROs and "niche providers"
• New outsourcing options

Part 1 Outsourcing Strategies

• The benefits of "strategic" outsourcing
• Developing an efficient outsourcing strategy
• Case studies of outsourcing

Coffee break

Part 2 Defining Accurate Study Specifications

• Three critical steps to ensure success with outsourcing
• What are study specifications?
• Defining and communicating accurate study specifications
• Breakout session: Preparing study specifications from a sample protocol

Lunch

Part 3 Requesting Proposals

• Prequalifying CROs
• Conducting a site visit
• Contents of the RFP package
• Instructions to bidders
• The resource allocations worksheet

Part 4 Selecting a CRO

• The selection team
• Evaluating bids
• Oral presentation of the bid
• The key criteria for CRO selection
• Group discussion: What are your experiences?

Part 5 Contracting With a CRO

• Objectives of the sponsor-CRO contract
• Obligations of the sponsor and CRO
• Transfer of obligations
• Types of contracts
• Breakout session: Negotiating a sponsor-CRO contract

Coffee break

Part 6 Managing the Outsourced Project: Clarifying Roles and Responsibilities

• Critical factors for ensuring a successful sponsor-CRO relationship
• Operating guideline for a sponsor and CRO
• Roles and responsibilities of the sponsor and CRO
• Succession planning

Part 7 Managing the Outsourced Project: Defining and Using "Performance Metrics"

• The value of performance metrics
• Examples of performance metrics

Part 8 Managing the Outsourced Project: Communication/Decision-Making

• Communication/decision-making model
• The "kick-off" meeting
• Periodic oversight meetings
• Characteristics of sponsor-CRO interactions
• Critical success factors for sponsor-CRO interactions

Day Two

Part 9 Problem-Solving

• Ten "red flags"
• Ten questions to ensure effective problem-solving
• Strategies for successful problem resolution (when to take action, where to start, when to escalate)

Part 10 Negotiation and Conflict Resolution

• Preparing to meet with the CRO
• Common negotiation topics
• Negotiation techniques
• Breakout session: Problem-solving exercises
• Group discussion: Problem-solving experiences
• Positive behaviors/things to avoid

Coffee break

Part 11 Solving Your Outsourcing Problems

• Group discussion: What problems are you having with outsourced projects?
• Recommendations from the group
• Plans for follow-up
• How can we become resources for each other?
• Lessons from other industries

Part 12 Evaluating Performance

• End-of-study meeting
• CRO evaluation database
• End-of-study self-evaluation by the sponsor
• Evaluation of the workshop

Workshop close

In-house Training Has Been Conducted For The Following Companies:

Comments From Training Participants In the U.S. and Abroad:

"Very much relevant to managing a current project."

"Realistic examples and problems."

"I am currently involved in a study with two CROs and everything explained is very relevant."

"Has perspective of both sponsors and CROs."

"Instructor is outstanding."

"Well presented."

"Excellent workshop; one of the best I attended."

". . . one of the most practical, and appreciated, educational programs we’ve had in several years."

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John R. Vogel Associates, Inc.
328 Pualoa Nani Place / Kihei, HI 96753
Phone: (808) 875-6063 / Fax: (808) 875-0913
Email: mail@jrvogel.com