Precision for Medicine Acquires ACT Oncology         

Regulatory Compliance Services

ACT oncology can work directly with Sponsors and Investigative Sites to prepare for regulatory agency audits. The key to the success of any product is ensuring that the clinical trials and development programs withstand the rigor of an independent inspection. ACT Oncology can provide Sponsors with an impartial assessment to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and regulatory guidelines necessary to verify the safety of study participants and the integrity and validity of study data. Quality and regulatory compliance assessments include various types of audits at multiple stages throughout a clinical development program. These assessments are necessary to ensure early detection of potential issues and allow for timely intervention and implementation of appropriate corrective actions without compromising data quality.

ACT Oncology provides:

  • Training in the areas of Good Clinical Practice /International Conference on Harmonization (GCP/ICH)
  • Support for clinical site preparations for Regulatory Inspection
  • Investigator Site Audits
  • Mock FDA Sponsor Inspections
  • Hosting of Sponsor Audits and Regulatory Inspections
  • Internal system audits of operational processes
  • Standard Operating Procedure (SOP) development and oversight
  • Vendor Qualification Audits –( pre-selection)
  • Ongoing quality audits to assess vendor adherence to contract responsibilities

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