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Quality Monitoring

At ASCENTH, the importance of Quality Monitoring cannot be stressed enough. Our dedicated Quality Management team brings extensive experience in providing independent evaluations to identify risks and errors, suggesting corrective measures in a timely manner to ensure the integrity and success of your clinical trials. Our comprehensive quality monitoring services include:

  • Site Audits: Conducting thorough audits of clinical trial sites to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
  • TMF Audits: Performing meticulous audits of the Trial Master File (TMF) to ensure all essential documents are complete, accurate, and compliant with regulatory standards.
  • Vendor Evaluation and Audits: Evaluating and auditing vendors to ensure they meet the highest standards of quality and reliability, ensuring seamless trial operations.
  • SOP Audits: Reviewing and auditing Standard Operating Procedures (SOPs) to ensure they are up-to-date, comprehensive, and effectively implemented.
  • Site Training for Regulatory Agency Audits: Providing specialized training for sites to prepare them for regulatory agency audits, ensuring they are well-equipped to demonstrate compliance and address any queries.
  • GCP Compliance Check: Conducting thorough checks to ensure all trial activities adhere to GCP guidelines, safeguarding the rights, safety, and well-being of study participants.

Our Quality Monitoring team is committed to maintaining the highest standards of excellence in all aspects of clinical trial conduct. By proactively identifying and addressing potential issues, we ensure the integrity of your data and the overall success of your clinical trials. Trust ASCENTH for reliable and thorough quality monitoring services that keep your trials on track and compliant.

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