Preparation of study related documentation such as the protocol, case report forms (CRFs), and informed consent documents

Establishing necessary documentation for ethics/regulatory approvals

Preparation and support during initial meetings with regulatory bodies

Pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice

Frequent reports and communications to keep you apprised of data accrual and quality on a site-by-site basis, and to assist in keeping the study team on track.