We provide direct submissions to the FDA either via our own access to the FDA Electronic Submissions Gateway (ESG) or through our preferred or your recommended eCTD vendor. We provide regulatory agency liaison services with industry standard record management practices.

• Coordination of NDA Submissions
• Preparation of ISS/ISE and other clinical sections
• Compilation of NDA sections
• Quality assurance

request for proposal

I have worked with Prosoft Clinical on multiple projects from Phase 1 through Phase 3 over the past several years and have used partial service to full service depending on the project. Prosoft Clinical’s team performs as if they were part of your own organization which I think sets them apart from other CROs. They are easy to work with no matter the scope of their services. We have had to have them rescue projects awarded other organizations in order to get the job done and meet timelines. Unlike some of the other CROs you aren’t nickled and dimed with change orders. Prosoft Clinical’s edc system is easy to use for both the sponsor and site personnel. Prosoft Clinical’s team has many years of experience working on the Sponsor side of the business so they understand their customers.

~ Sr. Director Clinical Operations