Clinical Development Outsourcing 101

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Home»Events»Clinical Development...Event Overview»Agenda Day Two

Clinical Development Outsourcing 101

October 11 - 12, 2006 | , ,

Agenda Day Two

8:00	Morning Coffee
9:00	PANEL DISCUSSION Outsourcing Tools and Content of Templates: Internal vs External Options for Use Bid grid, Proposal, Score card examples What's missing from your own templates? Advantages and disadvantages of different tools templates Sharing of experiences
9:45	Budget Basics Understanding unit cost, fees and pass-throughs Utilizing milestone payment schedule Using a budget template plus comparison spreadsheet to review costs
10:15	30-Minute Refreshment Break
10:45	Contract Approach and Development Determining the terms and conditions Defining the Scope of Work Creating timeline exhibits Understanding payment and business terms Grasping contract language and legal terms Regulatory, financial and legal considerations
11:30	Contract Management Payment tracking and use of operational and financial reports Scope change management and version control Change order processing Using standard approaches and templates Contract pitfalls Rate escalation Travel booking fees
12:15	Luncheon
1:15	VENDOR PANEL Lessons Learned from Contracting Processes Recommendations to improve quality and efficiency in the RFP process The RFP process: what do providers think is best? Harmonizing the bid grid with CROs for greater transparency and reduced negotiation Challenges of bonuses/penalties in contracts If you are interested in playing a role, please contact Delia Elbaum at 800-345-8016, ext. 3258 or delbaum@iirusa.com.
2:00	Post Contract Relationship Management Motivating performance of joint clinical study teams Evaluating performance, teams and expectations Optimizing communication across all vendors involved and Sponsor clinical team members Use of Operational Management/Executive Oversight Committees to optimize vendor performance and communication Articulating the functional services needed to a vendor Using service contracts versus operational guide documents Drafting and implementing an Issue Escalation Plan
3:00	30-Minute Refreshment Break
3:30	Use of a Governance Plan versus a Project Management Charter Incorporation of a communication plan Quality plan Project management plan Guidelines for appropriate oversight Risk management
4:00	Adhering to Timelines and other Measures of Success Using standard metrics, operational feasibility and reports to stay on track Identifying commonly used metrics Utilizing metrics to influence process change
4:30	Effective Project Closure Conducting lessons learned sessions
5:00	Program Concludes