Whitney works with our clients to ensure that the protocol is clear and easy to understand and will be followed by the trial site. Our consultants will guide clients throughout the ethical committee review until the protocol is accepted by all clinical sites.
Study Monitoring and Inspection
Whitney Consulting acts as the sponsor’s trial monitor to conduct regular inspections of the sites to ensure that the protocols are followed and the patient data are true and accurate.
Drafting Clinical Reports and Summary Reports
Typically a clinical study is done at two or more clinical sites. Whitney Consulting will work with each site to assist in completing their clinical report. Whitney also collects and summarizes data from all sites and will write the final summary report for the sponsor.
General Management of a Study
Managing a trial is time consuming and can be tedious. On behalf of our international clients, Whitney Consulting acts as the project manager for our clients. We manage and monitor the entire project: ensuring that timelines are met, activities are completed, and costs are within budget, all while maintaining transparency for our clients.
Whiney will manage the entire clinical trial project from protocol drafting to site selection to execution until the study is completed. We have extensive experience in IVD clinical trials.