Contract Resources for Sponsors/CROs

CRA

Clinical Research Associates are available for monitoring Phase I-IV clinical trials. The range of services includes site evaluation visits through final study termination (close-out) visits including client master file reconciliation.

Auditor

GCP auditors are available to develop a comprehensive auditing plan or conduct a single site audit.

CNI can also provide an auditor to a sponsor or a site to prepare for an audit, either a sponsor audit or before an FDA Inspection.

Project Manager

As a team is only as good as its leader, the project manager plays a critical role in the successful execution of a clinical trial. If your study calls for outsourcing of a project manager, CNI can provide a skilled and effective leader.

Site Recruitment/Investigator Selection

For clients who are just building site or investigator databases, or for seasoned industry anchors expanding into a new therapeutic area, finding the right sites is paramount. CNI will compile a list of sites known to have efficient IRBs, an appropriate patient population, skilled staff and a track record of successful enrollment.

Study Coordinator

We have all felt the crunch of a project that requires more from the clinical site staff than there are hours in a day. To meet a temporary need for data management or regulatory document processing, a contract study coordinator can make the difference between a goal met and a goal missed.

Remote Data Entry (e-CRFs)

CNI has worked extensively with electronic CRFs and electronic source documentation. Our consultants are able to evaluate database needs or explore the possibilities for modifying existing systems.