We have in house ISO9001 certified Standard Operating Procedures that comply with ISO14155 (EN450) and ICH-GCP regulations.
In fact, Factory is the first CRO in Europe to obtain ISO9001 certification for its Standard Operating Procedures. Of course we can use your company SOP's for conducting your clinical trial as well.
Factory's flat organization is a guarantee for low overhead costs, short and efficient communication lines. We work closely with the clients staff and are very keen on the quality performance of clinical studies.
Study audits/independent QA auditing Indicated on the annual audit plan include audits of subcontractors, study sites and may be requested by clients, focus on compliance with contract agreements, GCP and local regulatory requirements. Internal audits include study and process audits, focus on compliance with GCP, SOPs and protocols.
Factory is working according to the highest quality standards, applicable to clinical research:
