MONITORING IN CENTRAL & EASTERN EUROPE
 
Medical Experience

All CRAs and project managers are MDs with practical working experience in health care, many of them with a higher degree of specialisation. They have gained profound knowledge on country-specific structure of the health care system and treatment habits. They’ve got the medical background to understand aims and traps of a clinical trial concept and are able to assess the importance of events occurring during a patient’s treatment.

Source Data Verification

All monitors are native speakers in their area of operation and therefore have a direct access to the source data for verification. With a source data checklist per patient, kept in English, the sponsor will get for all countries involved a uniform documentation independent of the language of the source.

Trial-specific training

Monitors, project manager and assistants are trained prior to study start with regards to trial's clinical and medical background, its goals and traps, handling and organisation, to make the whole team familiar with the study and to find out necessary organisational adjustments.

Monitors attend regularly in-house training courses, either on a local basis or by the centralised QA service, and are continuously informed about new GCP- requirements and modifications.

Supervision and quality measures

All reporting from any country or CRA’s location to the project manager is email-based. Project manager timely evaluates emailed reports and immediately reacts to problems by appropriate means.
During the clinical trial, project manager, national study co-ordinators and CRAs exchange the latest medical and organisational experiences on a regular basis, either in group meetings or phone conferences.

Motivation

Well-trained monitors, working project- and not area- assigned in one or few projects only, feeling competent and responsible for their projects and sites. Their education as physician enables a colleague-like contact to investigators and an understanding of any medical event and the measures taken both in patient’s history and during the course of the study.

Work experience and staff turnover

Average work experience for CRAs is about 3 years, for senior CRAs/ project managers 5 years. Many staff members have been working for PHAMOS or in clinical research for more than a decade, some of them have an experience as investigator.

CRO’s expertise and experience is kept and continuously developed due to an extraordinary team stability.

Poland Czech Republic Slovakia Hungary Romania Bulgaria