Regulatory Development

Regulatory compliance is a key part of your clinical trial process. DF/Net can help you meet your FDA and other regulatory requirements with our expertise in:

  • SOP Development and Review
  • Quality Control Processes
  • DataFax Upgrade Validation
  • Data Management System Validation
  • System Event Management and Documentation
  • Security Training
  • 21 CFR Part 11 Compliance Consulting

For the past ten years, Phil Kirsch, the Quality Control Manager at DF/Net has lead the DataFax User Group Audit of Clinical DataFax Systems Inc. DF/Net has also provided detailed validations of various client DataFax systems, including the system used at the NIH.

Let DF/Net be your guide for the regulatory issues surrounding data management. We’re here to help.

How Can We Help You?

Phone: 206.322.5931
Fax: 206.322.5932
Email: info@dfnetresearch.com
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DF/Net Research, Inc.
140 Lakeside Avenue, Suite 310
Seattle, WA 98122 USA