The QA Team provides expertise in managing compliance with international Good Clinical Practices, European and national trial regulations, protocols, procedures and contractual agreements. At FSS we are committed to meeting the fundamental intent of those ethical and scientific quality standards to protect patient safety, wellbeing, rights and privacy and have confidence in the integrity of the trial data generated and results.

In addition to meeting our compliance obligations, QA adds value both to improve and adapt our clinical trial practices to meet objectives where one size does not fit all. We have a management commitment to a quality culture of transparency and knowledge sharing and where standardisation does not crush innovation as we encourage new approaches and technologies.

Throughout the study lifecycle, QA works closely with and provides the best possible timely and practical QA advice to study teams.

Our quality management system incorporates:

  • a robust quality management system that is fit for purpose and based on risk based approaches to achieve the quality necessary for critical trial activities.
  • the implementation of effective data handling Quality Control systems throughout the study lifecycle to ensure data integrity.

QA Services

  • Technical Writing expertise to create and maintain QA systems documentation including Standard Operating Procedures, Plans and Work instructions
  • Trial Master File Plans that reflect current industry standards
  • Procedure management and training and related deviation management across a range of different procedural collaboration models, including flexibility to work to external partner procedures, create study specific instructions/guidelines or harmonise procedures with other Frontier Science offices
  • Training in relevant areas including regulatory awareness, and compliance with Good Clinical Practice (GCP)
  • Expertise in GxP Computer Systems Validation guidance and direction including management of validation activities and tailored validation documentation
  • Auditing services to conduct vendor/supplier, CSV and investigator site audits

FSS strives to be both audit and inspection ready at all times, directing the need for relevant documentary evidence to be able to reconstruct trial activities and facilitate independent review.