Quality assurance

Quality Assurance and audits are one of the core businesses of S&P Pharmaterra. Therefore we have a very wide range of quality assurance experience. Besides the constant monitoring of the trial, our QA department performs internal audits on a routine basis. All the aspects of the trial undergo the scrutiny of our QA team. Our QA team works closely with our CRAs and our Regional Offices to ensure full simultaneous compliance to the local regulations, to the Sponsor's requirements, and to internationally accepted GCP/ICH standards.

Our professionals work with sites and investigators on maintenance and updates to the Standard Operating Procedures to guarantee that all the quality attributes are met. Our systems, processes and standard operating procedures are harmonized amongst our regional offices throughout Central & Eastern Europe.

We measure our operational performance so we have quantitative data that allows us and our clients to monitor our progress and measure our success. We ensure that our employees have the resources and training to perform to the high standards we and our clients require. The quality of your trial is unthinkable without proper documentation, archiving processes, and close cooperation with local IRBs.

We always pay special attention to:

  • Review and supervision of deadlines on completion of regulatory tasks at each and every site
  • Review of translations (National -> English -> National)
  • Critical (Essential) Documents package for drug release collection and submission
  • Proper filing of Investigator Trial File
  • Document Archiving
  • Documenting query resolution
  • Additional document preparation / collection
  • Narrative Writing
  • Timely and correct SAE reporting
  • Confidentiality of patient visits
  • Local/Central lab result reporting

Our policy toward documentation is based on notion "Every single document is an indicator of entire trial"