26.Jan.2012

OCT Successfully Passes Big Pharma Audit

Since 2007 OCT has been audited by external audits with the regularity of every other month. We are always happy to meet external auditors at our office. Fair and independent audit is beneficial to us in all respects.

Since 2007 OCT has been audited by external audits with the regularity of every other month. We are always happy to meet external auditors at our office. Fair and independent audit is beneficial to us in all respects. It is of extreme importance for the management of the company to have independent opinion regarding quality of our work and recommendations to improve.  For OCT it is very important because the company is growing very rapidly and today we are a company of 90 clinical trials professionals who are based in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria.

In January 2012 OCT underwent auditing conducted by the representative of one of the global pharmaceutical companies. The systems review was conducted in two days and involved review of OCT SOPs, staff personal files inspection, staff interviews, facilities inspection and presentations of OCT clinical trials services. No major findings related to company’s Standard Operation Procedures (SOPs), quality assurance system, trials setup and startup, sites identification and initiation, study management of clinical trials, documents management, regulatory services, local IMP management system, Information technology and safety management for clinical trials were noted by the auditor. OCTs Director Clinical Operations and Quality Assurance Managers demonstrated excellent quality and process control, within predetermined budgets and scheduling parameters.

The auditor noted such advantages of OCT clinical trials management as close control of company executives, straight-forward quality assurance system,  simple and effective organizational structure, professionalism  and flexibility at every level. Each project OCT takes on is with the understanding that it must meet all regulatory requirements and must pass our internal compliance checks to ensure success. Obtaining good clinical data from investigative sites is achieved by having the best-trained, highly motivated and dedicated staff on board. Our responsive and experienced people take care of every detail, giving our clients total confidence that all CRO services will be provided by professionals in an efficient manner. Our flexible approach gives us the ability to bring together an outstanding team to meet any requirements.