Faculty Connection, LLC, is a consulting company formed by faculty of the Duke Clinical Research Institute (DCRI) as a vehicle to provide advice and insight to companies in the health care arena in a more efficient manner. Our members are all practicing physicians who are also leaders in the clinical research arena, and they have significant experience interacting with the pharmaceutical, biotechnology and medical devices industries. They provide counsel and guidance in a wide variety of topics, including drug development, trial design, regulatory environment, market need, reimbursement issues, prescription patterns, disease management and other related issues.

Specific examples of possible consulting engagements may include:

• Protocol development for a new drug entering clinical trials
• Competitive assessment for a drug in a particular therapeutic area
• Assessment of implications of regulatory environment
• Know-how in regulatory submissions to FDA, CMS, etc.
• Strategy development for a particular product (or line of products) and services
• Tactical advice for rapid patient recruitment and other logistical issues in clinical research
• Market need assessment in a specific therapeutic area
• Estimation of market trends
• Scenario modeling and forecasting – probability of success for a pool of compounds