QUALITY ASSURANCE AND CONTROL

Quality Assurance and Control (QA/QC) is a critical component of clinical research. At Selsoft, we offer QA/QC services to help you ensure the integrity, accuracy, and reliability of your clinical trial data.

Internal Audits

Our team of experienced auditors can conduct comprehensive internal audits of your clinical trial operations to identify any areas of non-compliance, potential risks, or process inefficiencies. We use a risk-based approach to prioritize areas for audit and develop customized audit plans to suit your specific needs.

We can conduct audits of various aspects of your clinical trial operations, including:

  • Protocol adherence
  • Data management processes
  • Site and investigator selection
  • Regulatory compliance
  • Adverse event reporting
  • Drug accountability and storage
  • Patient safety

Our audit reports provide detailed findings and recommendations for corrective actions, and our team can work with you to develop and implement appropriate solutions.

Trial Conduct and Data Quality Monitoring

We can also provide ongoing monitoring of your trial conduct and data quality to ensure compliance with regulatory guidelines and industry standards. Our team can help you develop and implement monitoring plans, conduct monitoring visits, and perform data quality checks to identify any issues or discrepancies.

Our monitoring services include:

  • Site selection and initiation visits
  • Routine monitoring visits
  • Close-out visits
  • Data quality checks
  • Source data verification
  • Query resolution

We can work with you to develop customized monitoring plans that are tailored to your specific study needs and budget.

Compliance with Regulatory Guidelines and Industry Standards

We understand the importance of compliance with regulatory guidelines and industry standards in clinical research. Our team can help you ensure that your trial is conducted in accordance with applicable regulations, guidelines, and industry best practices.

We can provide support with:

  • Investigator training and certification
  • Site qualification and initiation
  • Regulatory submissions
  • Adverse event reporting
  • Data privacy and confidentiality
  • GCP compliance

Our QA/QC services can help you ensure the quality and integrity of your clinical trial data and minimize the risk of non-compliance. Contact us today to learn more about how we can help you with your QA/QC needs.