Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

Clinical Monitoring

Download a copy of FDA guidance on Risk-Based Monitoring (PDF 113kb)

Download Draft »

Selecting the right monitors is a critical part of the hiring for your project whether you hire internal staff or outsource. Unless you have a proven system for evaluating the monitors, your search for qualified experienced dedicated monitors can lead to hiring mistakes or delays as you scramble to find monitors. For smaller companies that don’t have the infrastructure, training and managing monitors can be a continuing challenge throughout the study.

Research Dynamics reduces the risk of finding and managing monitors. We have the ability to recruit the right monitors quickly and manage them to maximize their performance on your trial. We can provide the “best-fit” monitors to meet your most immediate and critical monitoring needs.

Our Field Monitors (CRAs) have years of experience to ensure optimal site performance. Their therapeutic experience enables a closer relationship with the site personnel as they understand the nuances of the protocol and how to overcome protocol challenges. They are respected advisors for the sites as a result of their experience and expertise. When on site, they work with site personnel to ensure data integrity and protocol compliance.

We use a mix of employee and contract field monitors which combines the advantages of both types. Employee monitors provide the instant availability and project control often needed during a project. Contract monitors offer flexibility and cost savings since they are selected for specific project needs such as therapeutic expertise, specific monitoring experience (eg, phase 1) or geographical region. Our monitoring force is flexible so we can rapidly increase or decrease our site visit frequency as necessary. Our monitors can be full time assigned to the project or used as needed to provide cost savings. We make every effort to use regional monitors to save travel costs and travel time.

Our average field monitor has over 5 years monitoring experience and therapeutic experience. Their backgrounds are typically nursing, or life sciences and some are certified monitors. Our in-house recruiters continually search for new monitors so our database is current and increasing. This database provides rapid deployment of qualified monitors for your projects. Please read our success stories.

We monitor investigator sites throughout the United States, Canada and Europe. All monitoring activities are conducted under GCP, ICH and FDA requirements. Monitoring is not an “add-on” service but one of our core competencies. So, you get the best monitors at the best value. Our processes are designed to be cost effective so each on-site visit is determined by the needs of the project and the site’s activity and not only by a calendar. We specialize in all types of monitoring:

Phase 1 monitoring:
Regardless of the type of Phase 1 trial, our experienced monitors are trained in the unique and complex requirements of this type of trial. Accurate and timely sample collection, proper handling of the samples and unique logistics are just some of the key areas that are part of the expertise of our phase 1 monitors.

Phase 2 and 3 monitoring:
Therapeutic area knowledge and monitoring experience are most important in phase 2 and 3 studies so these studies are where our monitors excel. These larger trials contain patient recruitment as well as protocol challenges and the RDCG monitors’ experience provides proactive emerging issue resolution.

Phase 4 monitoring:
Post marketing trials have difference requirements from the other phases. Our monitoring processes for these trials are also different and specialized for these types of trials.

EDC and monitoring:
EDC should reduce the time and cost to monitor a clinical trial. However, in order to maximize these benefits, monitoring processes need to be re-engineered. Research Dynamics has designed their processes to maximize EDC’s benefits and allow the monitors to work more effectively. Several years ago Research Dynamics was one of the first CROs to partner with an EDC company to provide a training and consulting program to assist sponsors in using EDC most effectively. See our release on our partnership with DATATRAK.

Review of real time data allows for more proactive monitoring responses to the data, reduction in queries, reduction in protocol violations, and faster access to adverse event information. These benefits allow the monitor while on-site to concentrate on protocol compliance and resolving site issues for more efficient monitoring and lower costs.

Although many companies have implemented EDC systems, they have not obtained the advantages of monitoring with EDC. EDC changes the conduct of the trial, the monitoring processes and the data processes to provide higher quality data faster. Research Dynamics was one of the first CROs to design, and implement these processes and provide these advantages to our sponsors.