CLINICAL TRIALS SITES
A global premarket and postmarket clinical development network
Premarket clinical trials are a critical phase in medical device development, requiring a high level of confidentiality, fast decisions and rapid start-up to advance the drug candidate. This “fast-track” approach requires lean processes, standardized contracting, and a thorough knowledge of the regulatory environments of various countries, and how these can be used to advantage while protecting patient safety and data integrity.
Clinical trials sites are typically commercial ventures, based on a different financial model than academic teaching hospitals. A CRO’s relationships with these sites should be based on true partnerships. This is key to differentiating the quality of service from that of loose, first-come, first-served relationships.
In operationalizing global early development studies, there are three main challenges:
There is strong competition for major studies. Hence, strong relationships with sites are essential to success. With a network of carefully chosen sites, ECLEVAR is able to leverage our experience and alliance with these sites to obtain priority placement of study. They assess feasibility quickly and are part of the early engagement process.
Timelines are key in drug devel- opment. Startup timelines are shortened by utilization of a simplified, fit-for-purpose process for start-up of early development sites, and standardizing templates for sponsor and site materials and documents. Use of master independent contractor agreements accelerates the study-specific contracting process.
Collaborative relationships between sites and CROs, with a predefined and agreed quality matrix, can yield optimal quality. Using trained and dedicated project managers and Clinical Research Associates (CRAs) co-located with sites facilitates monitoring that is close to real-time. External network sites are held to the same rigorous quality metrics as the ECLEVAR internal premarket clinical trials unit.