Program Day One

Opening remarks from the Chair

Evaluating recent and ongoing changes in the world of outsourcing in order to plan for future partnerships

• Assessing developments taking place in the CRO marketplace in order to establish a more effective decision making strategy
• Understanding the implications for sponsors and the opportunities that have been resulted from a more integrated CRO/Sponsor climate
• Overcoming the challenges presented by a more CRO reliant environment to exploit potential advantages without sacrificing autonomy
• Uncovering developing trends and what they will mean for the future of clinical trials outsourcing

Achieving clarity on how to identify the type of CRO that best meets the needs of your company profile to help you maximize ROI

• Establishing the needs for your trial in order to more effectively streamline the selection process
• Assessing the capabilities and specialities you require of your CRO
• Understanding whether a full service or function service model will offer the best return on the investment of your time and financial outlay
• Achieving a balance between price and quality by involving both the clinical and outsourcing teams in the selection protocol
• Revealing key strategies to make the right choices first time, every time

Best practices in vendor management and collaboration: case study on improving the sponsor-vendor relationship to create a win-win situation for all

• Traditional challenges for the technology vendor
• Understanding the challenges faced by the sponsor
• What can be done to help - Proven solutions to overcome challenges
• Role of outsourcing in improving the sponsor-vendor relationship and impacting the bottom line

Developing an effective strategy to maintain multiple contracts successfully and improve time and cost efficiency

• Establishing an optimal model for your clinical trial department to ensure that your protocol produces the best possible partnership every time

• Achieving a balance between over dependence on too few providers, and an unmanageable number of vendors

• Incorporating offshore CROs into your global strategy in order to promote good interaction and reduce the likelihood of error

• Reviewing supervisory strategy to improve your working relationships and increase efficiency

Panel Discussion
The tender process: how can you ensure that the proposal you receive is realistic and informative in order to avoid unnecessary change orders

• The Request For Information: ensuring that your request is sufficiently specific to allow the CRO provides a comprehensive and informative response
• Understanding the optimal level of detail in order to make efficient use of time without compromising the bid process
• The Request For Proposal: analyzing key questions to maximize the accuracy and relevance of the proposals you receive
• Developing best practice reviewing the bids to identify the CRO who best meets your needs
• Re-evaluating bid-grids and the need for negotiations to be based on a common language: avoiding all barriers to communication
• Comparing ‘apples to apples’ to make sure that the cheapest bid really is the best value

Establishing a workable contract that delivers on promises

• Optimizing the speed of your trial by identifying potential problems at the outset
• Asking the revealing questions: pinpointing unrealistic promises
• Defining effective due diligence procedure to ensure that your vendor offers what you need
• Ensuring that the bid is realistic and all-inclusive to minimize the chance of over-spending
• Clearly defining responsibilities and expectations in order to minimize oversight and achieve key milestones

A Case Study of Functional Outsourcing at Regeneron:

• How functional outsourcing fits into an outsourcing strategy
• Benefits of standardizing technology infrastructure
• Bundling of services and technology for key functions
• Building a knowledge base with standards and libraries
• Key Relationship Metrics and Guidelines