State and Federal Reporting

With Sample Compliance at the core of our business, Knipper now provides Federal and State Reporting. Our regulatory experts are equipped to handle any potential reportable incidents such as theft, loss and concealed shortage and provide guidance for resolution. All incidents are closely tracked in the Knipper Regulatory Compliance Tracking System.

Compliance Tracking

The Knipper Compliance Tracking System provides detailed information associated with each incident. Each reportable incident is assigned a unique number for easy tracking. Some of the capabilities include:

  • Trending Reports
  • Sample Accountability system data integrated with KCT to provide:
    • Roster Information
    • Product Details
    • Inventory Dates
  • Automated 30 Day Report Awareness

State and Federal Reporting Requirements

Knipper meets all requirements for state and federal reporting, such as:

  • Parties Involved:
    • Healthcare Provider Name
    • Representative Name(s)
  • Product Information
  • Date of Incident
  • Awareness Date
  • Theft Report
  • Quantity

Sunshine and Vermont Reporting

Our regulatory experts are well versed in reporting obligations such as federal disclosure requirements and individual state regulatory laws. They utilize their knowledge to:

  • Develop and maintain all internal policies
  • Ensure Knipper’s employees, systems, and practices comply with applicable sunshine laws

Data Extracts for Client Reporting

Knipper can provide data extract reports showing distributions of drug samples in aggregate by HCP (name, SLN) for a given year to support client processes for annual FDA drug sample transparency reports submission. Reports may also be used to further extract records specific to distributions made to the state of Vermont for that respective annual report.

Featured Services…

  • State and Federal Reporting
  • Data Integrity
  • Incident Tracking
  • Training and Education
  • Compliance Tracking
  • Regulatory Consulting