Since the investigator site produces the clinical data and other information that becomes part of a product approval application, the site is one of the most critical elements of a clinical trial. Our site management improves site performance through specially designed processes to ensure quality results from investigator sites.
Although on-site monitoring is important, technological advances have provided additional methods to improve site performance. Research Dynamics has developed unique site management processes that improve the quality of the site performance in patient recruitment, GCP and protocol compliance, and data quality. These processes include a more cost-effective on-site monitoring plan that decreases the non-value added costs of monitoring.
We call this our ICPSM Program or Intensive Care Program. This quality interaction could not occur through standard monitoring every 4 to 6 weeks. Our ICP program provides you with faster site start-up (faster IRB approval), higher quality data (fewer queries), and improved protocol and GCP compliance (fewer protocol violations). These operational efficiencies and quality levels would not occur with a traditional monitoring plan.