Specialized Products | Data Monitoring Committees
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Longitudinal Data Integration
Data Monitoring Committees (DMC)
Overview | Services | ClinicalSafety.net
Overview
There are different types of DMCs including Data Safety Monitoring Boards (DMSBs), Data Safety Monitoring Committees (DSMCs) and Adjudication Committees. The March 2006 “Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs)” signifies the FDA’s recognition of the DMC as an important tool for protecting patient safety and pro-actively managing potential risk. By providing a process-focused approach, Applied Clinical Intelligence (ACI) is one of the few companies that have a history of operating regulatory-compliant, business-focused DMCs.
ACI strives to operate a well-run, seamless DMC which not only offers insights that confer other benefits, but also ensures complete documentation and that there are no cost overruns or regulatory penalties. ACI recognizes that patient safety is good business. We offer both pre- and post-registration regulatory-grade, high-quality DMC products (proprietary CDISC based-processes and technology including the secure web-portal and Clinicalsafety.net™) with the following advantages:
- Systematic business-based approach to meet sponsor requirements for on-time, on-budget performance
- High scientific quality provided by independent experts with a focus on regulatory, not academic, safety issues
- ClinicalSafety.net™, our secure, single platform for documentation of safety issues
- Regulatory submission-grade programming and statistical services
A sample of our metrics:
Data Monitoring Committees |
|
On Time Delivery of Tables |
100% |
On Time Posting of DMC minutes |
100% |
Services
Our DMC Services are as follows:
- DMC Feasibility
- Charter Development (SOPs)
- Selection of DMC Members
- Meeting Preparation and Conduct
- Data Extracts and Visualization
- GCP-Quality Biometric Support
- Fully Integrated Safety Reports
- Expert Regulatory Consulting
Features:
- Rapid Identification and Recruitment of Scientific Experts
- Rapid Expert Integration of Disparate Data Sources (E.G. CRF, Laboratory, ECG, Etc)
- Scalability and Reproducibility
- Analysis Data Sets and Programs Can be Reused for Clinical Study Reports and Other Uses
- Technology Enhanced Rapid Responsiveness through ClinicalSafety.Net™.
ClinicalSafety.net
ClinicalSafety.net™ is ACI’s electronic platform that markedly increases the efficiency of expert committee deliberations. Whether it is a data monitoring committee, advisory board, adjudication or endpoint committee, ClinicalSafety.net™ provides the following features:
- Automatic electronic notification of safety alerts, reports and analyses through a highly secure web portal to geographically separated committee members
- Automatic notification via email alerts or cell phone or pager messaging when new information has been discovered and review of the new information is required
- Providing access to safety information on a 24/7 basis. This capability can provide better and more thorough scientific safety oversight and enhanced collaboration among the committee members.
- Full documentation and archiving
- Full search capabilities: documents can be searched by any content word, not just document titles
