Clinical Trial Monitoring

January 27, 2018
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Clinical monitoring services are a key part of your study success. Our monitoring approach is developed with a strong partnership between clinical operations and clinical data management.

With the success of Electronic Data Capture, the monitoring role has expanded. Our CRAs are both clinical and technical experts with EDC systems.

Our monitors are trained in site etiquette, communication, and proper documentation practices.

Clinical Monitoring Services

  • Our monitoring services offer Site Qualification, Site Initiation, Site Monitoring, For Cause, and Site Closeout visits.
  • PI and Site Personnel Training. Training can be conducted on-site or remotely.
  • We are experts in protocol compliance, regulatory compliance and source document review.
  • We offer Senior CRA services to provide oversight and guidance to field monitors (along with other in-house responsibilities).
  • Creation of core documents (Clinical Monitoring Plan, eCRF guidelines, etc.)
  • Performance of Sponsor-side duties like User Acceptance Testing of the EDC system from the Clinical Operations / Site perspective.
  • Risk based and remote monitoring in accordance with a risk assessment plan.

Study Start-Up

Study start-up is a pivotal phase in Clinical Data Management activities. Our team has experience creating hundreds of studies (Phases I, II, III, and IV). Key drivers during this period are Protocol finalization, SAP review, and eCRF design. This phase typically spans 4 months and requires significant efforts.

Our team will help you avoid costly errors and make the right decisions through this process. We communicate tasks and timeline status proactively. We understand that acceleration to go-live is often required and we can work with you on the best way to achieve your goals.

Study Conduct

Study Conduct brings challenges that our qualified team can help you solve. We help you make the right decisions by providing you critical study quality metrics.

Other CROs will often lose focus during this period of routine activity and fall weeks behind with data quality and queries. We are metric/quality driven and understand the importance of keeping the clinical study database current.

Study Close Out

Study close out is where you reap the benefits of experience. With BPG managing your start-up and conduct, study close out will be efficient and fast!

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