We create comprehensive, but efficient, monitoring plans to manage clinical trials and engender confidence in your clinical trial integrity. Analytics are used to implement a risk-based approach to monitoring, which cuts costs without sacrificing assurance of data reliability, investigator compliance, or meeting regulatory reporting obligations. Active clinical monitoring can help predict potential clinical trial challenges or at least identify issues early so they may be addressed before they lead to significant delays, lead to increased costs, or derail the trial completely.
Ultimately, if clinical trial data are untrustworthy for any reason, or are dismissed by regulators due to compliance concerns, the entire endeavor becomes a waste of time and resources. We focus on comprehensive site training with continuous performance monitoring to ensure study sites are providing the highest quality data. Intermittent retraining is performed as needed to ensure site performance throughout the duration of the trial. To ensure data integrity, MED clinical research associates and monitors verify the clinical trial data and verify that the trial sites are conducting the trial in accordance with the trial protocol and all applicable regulations and ethical standards (e.g., Good Clinical Practice; ICH GCP).
Our team can help you determine whether additional safety monitoring is appropriate for your clinical trial and convene one or both of the following study monitoring boards, as appropriate:
A Data Safety Monitoring Board (DSMB) is a panel of independent experts who review the safety information of a clinical trial as a whole to determine whether its risk-benefit profile remains acceptable throughout the course of the trial.
A Clinical Events Committee (CEC) is a panel of independent experts who evaluate the circumstances of individual events that occur within the trial. The CEC adjudicates whether the observation meets protocol defined event criteria, as well as the cause of each event (i.e., whether the event was related to a pre-existing condition, the investigational product, the investigational procedure, etc.).