Site Support & Trial Master File Management

We facilitate communication and coordination between the sponsor, sites, CRA’s, IRBs, and other parties (e.g. vendors, safety committees and outside data management). We help develop processes to ensure action item resolution and accountability documentation.

Sites often struggle with complex protocols and data collection or procedures that fall outside their standard of care. We offer customized training and tools to uphold protocol compliance. Our monitors are always available to coach sites and act as a line of communication to the sponsor.

CRA Solutions uses an Essential Document Plan to QC all documents and prevent issue, track and manage to ensure ongoing compliance. We create document indexes, update schedules and other useful tools to help both sites and sponsors maintain regulatory files that are always audit-ready.