CLINICAL MONITORING OVERSIGHT
Ensure your clinical trials are executed well.
The hard truth is: Clinical Oversight is essential — and required. Ensuring that your trial is delivered with the highest of quality, on time, and on budget is essential with the escalating costs to conduct clinical trials and to avoid unnecessary and often required, change orders.
KPS brings key elements directly to the trial site. Our Clinical Monitoring Managers ensure that either your CRAs or those of the CROs that you selected are working effectively, following protocol, in compliance with ICH E6, driven by the best processes, and on-track to generate data that’s useful for FDA approval.
Download the infographic, “5 Keys to Controlling Clinical Trial Costs.”
Common “control issues” at clinical sites
Problems due to the CRA’s lack of training or experience
Environmental issues, such as fatigue or stress
Inefficient or problematic protocol or CRF
Clinical Monitoring Oversight (CMO)
Be assured that everything at your trial site is being executed the right way — and that your critical deliverables will be ready on-time, within budget and most importantly, with the highest quality:
Know
that site activities are being implemented correctly
Ensure
the quality of the monitoring data
ESTABLISH
compliance with FDA’s ICH E6
MITIGATE
problems quickly to avoid costly delays
GET HELP
with upcoming FAD audits and inspection readiness
INCREASE
confidence, and speed, for the Sponsor
“KPS brings more control back to the Sponsor — with an improved culture that both the pharma and FSP employees feel more connected to deliver together.”
Mark RidgeLearn how KPS conducted 60 monitoring oversight visits to help a mid-sized pharma company “right the ship”— and save 30% in Year 1.
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To see how Clinical Monitoring Oversight (CMO) can benefit your Sponsors, give us a call.
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