2113 Wells Branch Pky
Suite 6900
Austin, Texas 78728
512-782-8204

Quality Assurance

Maintaining Quality and Consistency…

 

The staff of SlieaGen diligently performs site audits to verify that the protocol is performed according to sponsor's Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and International Commission on Harmonization (ICH) standards.

As part of a meticulous review, SlieaGen personnel will verify that

  • Informed Consent documents are present and complete
  • All documents concerning interactions with the IRB/IEC are on file
  • The documents and procedures concerning sample collection, handling and storage are followed and complete
  • All facilities and equipment are adequate
  • Data collected in a representative sample of Case Report Forms are authentic and supported by source documents.
  • Records and procedures for site visits are reviewed; corrective actions completed and documented if necessary
  • Site is compliant with internal Standard Operating Procedures.

SlieaGen’s commitment to quality strives to ensure our Client’s satisfaction.

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