We provide top quality – and it´s official

  • More than 10 audits/inspections by local authorities, sponsors, EMA, and FDA passed with flying colours.
  • The latest FDA inspection of two German study sites managed by SSS came through with a "no findings" verdict
  • Certified QM system DIN EN ISO 9001:2008
  • Standard Operating Procedures (SOPs) available for all services
  • Regular internal or sponsor initiated audits of QM system
  • Certified BVMA member

Quality from start to finish

Process definition is a key aspect of quality. While Good Clinical Practice (GCP) guidelines set the framework, much experience and permanent improvement is needed to define exactly what processes are needed to get optimum results – meaning the best possible quality. But not even the best standard operating procedures (SOPs) are any good without permanent adaptation to new regulations, continuous training and checks to verify proper implementation. Here, you need people with the right mindset who are dedicated to a structured approach and maintaining high standards. Having started out as an auditing service, SSS has attached importance to quality issues from the word go and attracted employees who share that preference.

Auditing services

With regulatory inspections on the rise, you need to be sure your sites adhere to the most stringent requirements for compliance and patient protection. Our rigorous auditing process is designed to identify and address issues before the authorities do and prepare your team to answer questions with confidence.

Our company has experience in performing audits on all trial-related processes and functions since 1993. SSS International Clinical Research devotes special attention to compliance with GCP requirements and the quality of generated data. Our company operates in compliance with the international standard ISO 9001:2008 for Quality Management (QM).

Independent auditing can pinpoint problem areas, reduce future costs, streamline project schedules, and ensure regulatory compliance.

Our audit services include the following:

  • System audits
  • Investigator site audits
  • Customer audits, service provider audits
  • Trial Master File audits
  • Protocol audits
  • Database audits
© 2018 SSS International Clinical Research