Quality Assurance

Presentation

Experience

  • Biotrial SOPs concern all Biotrial activities and are written according to regulations (GCP, GLP, GMP) and ICH recommendations
  • Use of Biotrial or Sponsor’s SOPs

Staff

  • Experienced team in GCP, GLP, GMP and IT validation
  • Knowledge of big pharma companies process and support for medium/biotech companies

Expertise

Internal Audits
Biotrial’s Quality Assurance Unit’s internal audits cover all internal systems, processes and facilities (Non-Clinical, Clinical, Data Management, Biostatistics, Medical Writing, Patient Trials and Oncology).

  • Supplier audits
  • Study audits
     

External Audits and Inspections
A member of the Quality Assurance staff assists the auditor mandated by the sponsor

In case of an inspection from authorities (ANSM, FDA, other), our Quality Assurance staff will perform a pre-inspection audit and will assist the inspectors during their entire inspection.
 

SOP Management
Biotrial SOPs are written by operational staff, who actually perform the procedures and have the best knowledge of their own work. The Quality Assurance Unit will then be in charge of :

  • Checking the accordance with the regulations
  • Following SOP review and reading
     

IT Validation

  • A Quality Assurance member is present in each validation team in order to carry out the validation files and to follow their update.
  • All the IT systems generating data are validated in order to follow 21 CFR part 11 regulations.
     

Training
The Quality Assurance staff is in charge of:

  • Initial training concerning the regulations and the Biotrial SOPs
  • Continuous year-round training on new SOPs, regulation processes - including regular trainings on ICH GCP for clinical teams - and audit remarks