Having a Prosperous New Year with a CRO: The Gift

Transcript:Having a Prosperous New Year with a CRO: The Gift:
Having a Prosperous New Year with a CRO: The Gift of A Great Contract Paul G. Nardulli, Attorney At Law, Optima Law Group Claudia Shojai, Supply Chain Supervisor, INOVA Diagnostic Moderator: Tim Scott, President, Pharmatek CRO Industry CRO industry is booming, taking a larger piece of worldwide R&D expenditures -- $14 billion by CROs in 2012 The industry is fragmented with over 1000 CROs, including: A small group of large, full service multinational entities representing 50% of worldwide CRO revenue The remaining CROs being small to mid-sized entities providing a more limited menu of services, including: Niche CROs providing services in a limited geographic region or on a specific disease state or therapeutic model Potential Advantages of CROs Reduce: Time needed to develop and commercialize a new drug Sponsor’s fixed costs associated with personnel, equipment and facilities needed for its R&D function Provide: Ready access to needed expertise and/or technology Greater access to potential investigators Knowledge of regulatory climate in foreign markets Potential Risks of Outsourcing to CROs Risks generally associated with reduced control of the clinical trial process by the Sponsor Risks include: Delays in completion of studies Lost or poor data Regulatory infractions produce indirect consequences FDA regulations/GCPs HIPAA Fraud and Abuse Private litigation exposure Factor Most Often Causing Study Delays United States Whose and what expectations are being met with the contract? When gifts are expected and not delivered, there is little to celebrate Proactive approaches to contract management. Contract management and oversight is one now integral part of a critical clinical strategy. Are the Sponsor and CRO proactively managing the contract in order to tackle issues that arise? A contract is the key link between strategy and execution. Total Contract Management strategy will prepare your organization to better manage expectations. Contract Lifecycle Management Whose and what expectations are being met with the contract? When gifts are expected and not delivered, there is little to celebrate Clinical Trials Success begins with the scope of work Clinical Trials are often derailed by a fundamental lack of clarity in the scope of work between the sponsor and the CRO and other vendors. The devil is in the details. A strong starting point is a detailed Task Order Agreement that clearly outlines the scope of work, the timelines, and responsible parties. Cost overruns, delays, and damaged sponsor/vendor relationships create havoc in clinical development programs, and create a tremendous fiscal and