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Clinical Trial Monitoring

Clinical Trials

We create comprehensive, but efficient, monitoring plans to manage clinical studies 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).

Auditing

A clinical audit can be carried out as an independent assessment of compliance with the clinical trial protocol, regulatory requirements, and relevant standards such as ISO 14155 and ICH GCP. The scope of an audit may cover the entire clinical trial or any piece therein, such as an audit of the CRO or an audit of a clinical trial site. Audits may be planned periodically or performed ad hoc as the result of a risk analysis.

Our auditing services can assess the compliance of your clinical trial to ensure integrity of the trial data, documentation, and procedures. We will identify potential risks and find proactive resolutions to issues that could otherwise jeopardize the clinical trial or its results. Along with a report of the audit findings, we also provide recommendations based on 30+ years of experience managing successful clinical trials to improve compliance or to improve your quality systems and procedures. We can walk you through the process of implementing these enhancements and even provide clinical trial staff training to avoid issues in the future.

Safety Monitoring

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.).

Through active monitoring and trend analysis, our expert trial managers ensure timely reporting to the DSMB/CEC to meet the notification requirements. We regularly meet with them to provide supporting information and larger context for events that occur within the trial. Then we incorporate the resulting findings to optimize the conduct of the trial wherever possible.