Protocol Synopsis and Full Protocol Development
Our own expertise, combined with access to key opinion leaders, will result in a focused, feasible protocol that will be readily accepted by Regulatory Agencies, IRBs/IECs and investigators.
Investigator Selection and Contracting
Through extensive trial management experience, we have learned how to efficiently access the correct type and number of investigators for on-time, within-budget delivery of quality data. We can advise on appropriate Principal Investigator strategies for the region, country, or site depending on specific requirements and business goals. We can help assess the pros and cons of alternative strategies. We have the know-how to determine the distinctive motivators of different investigators to "sign on" or opt out of specific trials, and how to build those motivators into a "win-win contract".
Clinical Vendor Selection
We can help develop and implement a clinical vendor strategy that dove-tails with your current staff, and future staff plans, to optimize internal and external human resource and technology utilization. We have extensive experience in vendor assessments as well as critical factor assessment for successful sponsor-vendor partnerships.
Resource Needs Planning & Assessments
We have established processes and metrics that deliver results in a much more timely fashion, and at a lower cost, than conventional approaches and traditional methodologies. Our unique knowledge and experience will help you simplify data collection and study monitoring. The end result is improved quality, and time- and cost-savings, which will significantly save on your scarce resources.