Execute 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 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.
Problems due to the CRA’s lack of training or experience
Environmental issues, such as fatigue or stress
Inefficient or problematic protocol or CRF
If you would like to learn more about how KPS Life’s Clinical Monitoring Oversight services can play a critical role in your clinical study success, please contact us today.
Clinical Monitoring Oversight
Helping Sponsors Improve Patient Quality of Life & Save Lives
When studies are outsourced to Clinical Research Organizations (CROs), site monitoring becomes the CRO’s responsibility. Nevertheless, it is crucial for the Sponsor to maintain oversight of monitoring operations and evaluate the quality of the service, since consequences can be severe if issues go unnoticed.
KPS Life’s fully global team of experienced oversight monitors and managers has excelled in providing sponsors with a truly independent and objective third-party assessment of their outsourced monitoring services since the release of the FDA guidance in August 2013.
As an organization focused on curating outsourced services and solutions for Phase I through Phase IV clinical trials, KPS Life’s market-proven Functional Service Provider (FSP) model lifts the traditional burdens normally associated with internally managed clinical monitoring oversight tasks.
KPS Life oversight monitoring team provides the Sponsor with monitoring assessments and trend analysis to ensure that our Sponsor’s protocols are executed at the highest level of quality. With this information, the Sponsor can put additional processes, training, and changes in place to ensure that the trial, including the investigative site, is inspection ready.
To guarantee quality and successful outcomes, our Oversight Monitoring solutions are comprised of experienced Oversight Monitors and Managers with many years of on-site and remote global monitoring experience (typically 8+ years of experience). Each team member is trained in the study’s protocol, the Sponsor’s internal processes, and all relevant regulations.
Our +85% CRA retention rate helps us ensure that our Sponsors receive the support and project stability they deserve and require.
With a focus on efficiency and utilization of team members, studies are managed successfully within budget parameters.
Our solution is implemented to make certain that our Sponsor’s CRAs (Clinical Research Associates), or those of the CRO partner they select are monitoring effectively, to ensure the sites are adhering to protocols, following ICH E6 guidelines, employing best processes, and are on track to generate clean data for FDA approval.
While KPS Life manages the clinical monitoring oversight process, Sponsors still maintain 100% project control. We ensure our monitoring data is accurate, up-to-date, and always accessible.
Nearly two decades ago, KPS Life changed the clinical study industry by introducing our Oversight Monitoring through our Functional Service Provider model. We knew there was a better way to ensure quality monitoring outcomes, deliver significant cost savings, and lift many costly and administrative burdens from our Sponsor partners.
“KPS Life 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 Ridge
Vice President, R&D Project Management , Sponsor Company
Learn how KPS Life conducted 60 monitoring oversight visits to help a mid-sized pharma company “right the ship”— and save 30% in Year 1.
