Source Data Monitoring

As a sponsor of human clinical trials that evaluate new drugs, biologics, and medical devices, you are responsible for maintaining a high standard of quality and ethics. This means that you must ensure that study participants’ rights, welfare, and safety are protected, and that accurate data are collected, analyzed, and reported to regulatory authorities. Source data verification is one of the methods you use to ensure your clinical trial results in data of the utmost integrity.  In today’s fast paced clinical trial world, sponsors need to have confidence in the expertise of their monitoring group to ensure high quality on-site, remote, and risk-based monitoring.

At HCC, we aim to ensure just that.  Our monitors will audit compliance to FDA GCP regulations and adherence to ICH guidance standards in the conduct of clinical trials. Our clinical consultants possess extensive on-site and remote monitoring experience including risk-based monitoring models. We excel at using a variety of data collection processes, such as paper CRFs and electronic databases.

Clinical study monitoring requires excellent attention to detail, thorough knowledge of clinical trial regulations, and a working understanding of medical terminology and clinical pathology.  Many of our associates are former nurses, radiology technicians, and vascular technicians who have expertise in catheterization or surgical suites.  We place high value on excellent communications skills and emotional intelligence in our associates and we consistently receive feedback from sponsors and site personnel that our experts are knowledgeable, accurate, detailed-oriented, courteous, and achieve study goals and milestones.

Impact

Compliance with FDA, GCP, and/or ICH guidelines and adherence to quality plans and systems ensures accuracy, quality, and consistency of your clinical trial data. Clinical trial data with high integrity is less likely to be questioned, which can cause delays in approval time.

Specific services we offer:

  • Developing comprehensive monitoring plans, traditional or risk-based
  • Complete source data monitoring, either on-site or remote
  • Source data monitoring tailored to your study, your needs
  • Planning and conducting site initiation visits and training
  • Planning and conducting interim monitoring visits
  • Planning and conducting closeout monitoring visits
  • Familiarity with numerous EDC systems
  • Identifying, managing, and resolving data queries
  • Identifying, communicating, and tracking data trends
  • Troubleshooting
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