It goes without saying that quality work is always Factory-CRO’s first concern. Factory-CRO has in house ISO-9001 certified Standard Operating Procedures that comply with ISO14155 (EN450) and ICH-GCP regulations.
In fact, Factory is the first CRO in Europe to obtain ISO-9001 certification for its Standard Operating Procedures. Of course we can use your company SOP's for conducting your clinical trial as well.
But great SOPs are not the only reason our quality is second to none. Factory-CRO's flat organizational structure makes for short and efficient lines of communication, and strong work teams. Our staff and our clients quickly form an integrated team working toward a common goal of quality results.
Study Audits / Independent QA Auditing
Factory-CRO regularly audits our study sites and subcontractors and we encourage our clients to do the same. Our external audits focus on compliance with contract agreements, GCP and local regulatory requirements. Our regular internal audits include study and process audits with a focus on compliance with GCP, SOPs and protocols.
Factory is working according to the highest quality standards, applicable to clinical research:
