Quality Assurance and Regulatory Affairs

The Quality Assurance (QA) and Regulatory Affairs(RA) department missions are two-fold: QA activities and RA activities.

QA & RA Team is composed of:

  • The QA & RA Director
  • The QA & RA Associate
  • The QA Clinical Project Manager
  • The QA Clinical Project Manager Junior
  • The QA & RA Executive Assistant

QA Goals are:

  • To ensure that all clinical trials conducted by TRIO are in compliance with the ICH/GCP guidelines, the 21 CFR Part 11, all applicable national regulations and in compliance with the TRIO or Sponsor/Manufacturer's SOPs as applicable.
  • To improve the quality of TRIO activities.

QA Activities are:

  • To design an appropriate Quality Management System (QMS)
  • To come-up with proposals in terms of process changes as appropriate
  • To manage the development and revision of all TRIO SOPs in collaboration with appropriate TRIO Departments
  • To train TRIO staff and communicate on GCP, Computer System Validation (CSV) and SOPs
  • To give advices to TRIO staff on GCP, on CSV, in line with applicable SOPs
  • To conduct Internal Audits, External Audits such as Vendors Audits and Site Audits
  • To host Sponsor Audits (or Inspections if any)
  • To implement any corrective and prevention actions
  • To review study documents (Protocols, PICF, CRF, CSR…) from a QA perspective
  • To review and approve all "key" CSV documents (e.g. URS, Validation and Test Plans, Test and Validation Summary Reports…)

RA Goals are:

  • To provide regulatory expertise within our Organization contributing to sound decision-making
  • To manage clinical trial applications to Competent Authorities and Ethics Committees for trials where CIRG is the Sponsor and/or Applicant.

RA Activities are:

  • To ensure a regular review of the relevant regulations applicable to our business (QMS, Clinical trials, Ethics, Clinical Trial Applications, CSV ...)
  • To develop tools such as summaries of local regulatory pre-requisites applicable to our business
  • To train TRIO staff on regulations of interest as needed
  • To give advices on any local regulations to TRIO staff
  • To perform the CTAs / INDs submissions
  • To review study documents (Protocols, PICF, CRF, CSR...) from a RA perspective