FSP
We offer a range of ‘flexible’ contractual engagement models ranging from project outsourcing and functional insourcing (FSP).
Often sponsors prefer that vendors utilize their statistical computing environments, macro systems, and SOPs for a greater level of continuity, compliance and for more consistent input throughout the clinical development process. Or there can be times when hiring permanent staff is not the best option for you. In either situation NJS can save you both the burden, and direct cost of recruiting, training, and paying employee benefits. Moreover, you can scale up or cut back quickly depending upon your departmental resourcing requirements.
NJS provides our customers with the security of knowing that our functional teams are highly qualified for the tasks in which they are allocated. Our resources are led by veteran Project Managers, who have many years of managerial experience. They can supervise training, compliance, timelines, quality, and budgets, to become a true extension of your internal department.
It goes without saying that there are many reasons why companies often choose to insource expertise rather than outsource projects or hire it directly. With that in mind, NJS’s domain specific expertise, operational knowhow, combined with our extensive network of industry talent enables NJS to deliver highly qualified resources in a comprehensive range of biometrics functions.
Areas of expertise:
- Biostatistics
- SAS Programming
- Clinical Data Management
- Data Monitoring Committee Support
Other Services
Biostatistics
Strategic Planning for Clinical Development, Endpoint selection, Study design, Submission strategy, SBA Review, FDA communication.
SAS Programming
CDISC data standards, industry data standards, and FDA compliance are always at the heart of every statistical programming task that we undertake.