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Auditing-Data Review

By Norwich Clinical Research Associates

NCRA is highly experienced in providing GCP Audit and Data Review services customized to meet your project-specific needs. Whether it involves establishing a data safety monitoring board, assessing existing programs for managerial acquisition decisions, performing internally motivated quality service or pre-application submission audits, or responding to an FDA data audit request, NCRA is able to provide you with the specialized assistance you require.

We understand the time constraints placed on such projects and have the expertise necessary to get your project up and running quickly and completed within the tight timelines that such projects require.

NCRA's Auditing teams are dedicated to providing exceptional and timely service. In order to do so they provide:

  • Experienced auditors/reviewers and auditing/reviewing teams, as appropriate to the project
  • Customized standard operating procedures (SOPs) to meet the project's specific needs
  • Auditors skilled in monitoring and regulatory compliance issues
  • Auditors and data reviewers trained to protocol-specific and disease-specific indications
  • A project manager to act as the liaison to you the client, and as your liaison with the involved regulatory agencies

The services provided by NCRA will vary in accordance with your auditing/review needs. For example, your team can:

  • Set-up a data safety monitoring board (DSMB) specific to your project's therapeutic requirements
  • Produce and implement SOPs or DSMB rules of engagement that meet FDA requirements
  • Develop auditing plans that meet with FDA concurrence
  • Assist with development and implementation of corrective and preventative action plans to address internal audit or FDA citations
  • Deliver project reports that keep you abreast of project status
  • Manage your DSMB third party contracts and payments
  • Provide accurate documented tracking of the project's materials, e.g., auditing worksheets or data measurements

If you find yourself in need of assistance give NCRA a call and let's discuss how we can best meet your specific company needs.