Clinical Monitoring Oversight
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 Life 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.
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 FDA audits and inspection readiness
- Increase confidence, and speed, for the Sponsor