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  • Quality Assurance and Compliance:
  • MakroCare staff is accessible and responsive to questions and requests for information during any part of a study. We provide an independent assessment of the client's quality assurance procedures, based on Good Clinical Practices (GCP), regulatory requirements, (e.g. ICH, FDA), state and local regulations, and MakroCare or sponsor Standard Operating Procedures (SOPs).

  • MakroCare maintains a series of in-house Standard Operating Procedures (SOPs) that are carefully updated as regulations change. We consult on and develop SOPs and project-specific documents, and assist client with writing Standard Operating Procedures (SOPs) and updating SOPs for current compliance.

  • Our quality assurance services include:

  • Investigator site audits
  • Database audits
  • Clinical study reports
  • Integrated report audits
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