Experienced personnel are also an integral part of successfully conducting clinical trials “on the ground” in Europe. They speak the language, understand the customs, and know the ins and outs of obtaining regulatory and ethical approval for trials. In some disease states there is intense competition for treatment-naïve patients, and the ideal CRO partner can identify which medical centers and investigators are most likely to achieve enrollment goals.
“On the ground” experience also includes finding ways to make the clinical trial process as easy as possible. When implemented properly, the best solutions can reduce costs via faster start-up and enrollment times and fewer queries about procedures and data. Ideas can be as simple as providing sites with a troubleshooting contact in the same time zone and as complex as developing a unified technology that enables integration, collaboration, and transparency across all trial stakeholders.
This type of technology has the potential to save time and money for the investigators, the CRO, and the sponsor. For investigators, an integrated, streamlined, easy-to-use platform means they and their staffs need to use only one program for all trial-related tasks instead of having separate systems for trial documentation, procedures, data entry, pharmacovigilance/safety, etc.
A single program requires less training time and eliminates the need for duplicate data entry into multiple systems. Ideally, the technology is configured to help the sites enroll appropriate patients by verifying that potential subjects meet the predetermined inclusion and exclusion criteria. The system should also detect and flag protocol deviations (e.g., an on-trial patient is prescribed a contraindicated medication) in real time. With these features the sites need less training on the details of the trial protocol, and investigators have more time to focus on their primary goal of high-quality patient care.
Providing technology-amplified services benefits the CRO because their personnel spend less time answering questions from sites and more time ensuring data quality. If the platform uses a web-based interface, clinical trial monitors are able to review study records online.