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