CRO Oversight & Optimization
In August 2013, the FDA released its guidance for monitoring clinical investigations. According to the document, the FDA’s overarching goal is to “enhance human subject protection and the quality of clinical trial data by focusing Sponsor oversight on the most important aspects of study conduct and reporting.”
What does this mean? In layman’s terms, that the FDA understands that contract research organizations (CROs) have had challenges on the quality of their deliverables to Sponsors throughout the trial duration and there are no guarantees on the quality of the work. This is not only disruptive to Sponsors, but to the FDA itself, the life sciences industry, and the patients who are made to wait for new treatments because of shoddy clinical trial work.
KPS is the industry leader in providing oversight of outsourced clinical vendors. Our rigorous methodology — known as CRO Oversight & Optimization — ensures an unparalleled quality of onsite monitoring throughout your clinical trial. Our team reports and remediates any clinical issues before they arise, working in collaboration with our Sponsor’s clinical operations teams. And, they close gaps throughout the process, optimizing outcomes as a trial moves closer to filing.
Trials that are delivered on-time and on-budget, and with the highest quality results/data … which further results in drug reviews that transcend human-error problems and receive approvals more quickly.