INVITRO is the First Russian laboratory certified in accordance with ISO15189 standards (medical laboratories requirements for quality and competence) and ISO9001 standards (quality management systems requirements)
- We work in accordance with ICH-GCP. All the employees of CTU pass both internal and external training, including GCP and GCLP courses;
- An internal audit is carried out in CTU annually (confirming compliance with ISO 15189 and ISO 9001 standards);
- INVITRO LLC has produced a Clinical trials Manual describing all Clinical trials processes and patient enrollment procedures. SOPs and Instructions are determined and every step is described for each trials process. All the SOPs are written by process owners and are reviewed annually;
- All the electronic systems used for Clinical trials are validated;
- At CTU there is a quality Manager who is responsible for monitoring the maintenance of all quality aspects of CTU processes;
- INVITRO is audited by external quality assessment systems on regular base (EQAS – US, RIQAS – UK, FSVOK – Russia)
- We are regularly involved in Sponsor audits and carry out corrective and preventive actions